Acne Inversa
Conditions
Brief summary
This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing Period and a 4 week Follow up Period.
Interventions
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
The treatment period is a parallel design
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa
Exclusion criteria
* History of human immunodeficiency virus (HIV) or positive HIV serology at screening, * Infected with hepatitis B or hepatitis C viruses. * Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | At week 16 | HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | At weeks 1, 2, 4, 6, 8, and 12 | HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | At week 16 | This estimand was intended to provide difference between treated and placebo in percentage of participants with a total AN count of 0 or 1, or 0, 1 or 2, respectively at week 16. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | At weeks 1, 2, 4, 6, 8, 12 and 16 | The analysis of covariance (ANCOVA) model was implemented for statistical testing, which included terms of treatment group, the stratification factors, and the baseline value as the independent variable. |
| Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | At weeks 1, 2, 4, 6, 8, 12 and 16 | The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome. |
| Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | At weeks 1, 2, 4, 6, 8, 12 and 16 | The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome. |
| Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | At weeks 4, 8, 12 and 16 | HS flare was defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19. |
| Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19. |
| Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method. |
| Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | At weeks 1, 2, 4, 6, 8, 12 and 16 | Erythema response was defined as achieving erythema score of 1 or 0 in all affected anatomic regions among participants who had an erythema score of 2 or more in at least 1 anatomic region at baseline. NRI for missing values which were related to withdrawal and all other events except for COVID-19. A four-point ordinal scale ranging was used: 0 (no redness), 1 (faint but discernible pink coloration), 2 (moderate red coloration), and 3 (very red or bright red coloration). |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Up to 20 weeks | The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs. |
| Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Up to 20 weeks | The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs. |
| Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Up to 20 weeks | The vital signs were measured included temperature (Oral, Tympanic, Axillary or Temporal), pulse rate (beats/min) and blood pressure (mmHg). |
| Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Up to 20 weeks | Laboratory test abnormalities included hematology, chemistry, urinalysis and biomarker. |
| Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | Up to 20 weeks | ECG parameters included QT interval, QTc interval, PR interval, and QRS complex. |
| Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | At weeks 1, 2, 4, 6, 8, 12 and 16 | The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed. |
| Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | At weeks 1, 2, 4, 6, 8, 12 and 16 | The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed. |
| Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | At weeks 4, 8, 12 and 16 | The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of Not at all, A little, A lot, Very much. The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. |
| Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | At weeks 4, 8, 12 and 16 | The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of Not at all, A little, A lot, Very much. The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined a change from baseline in total score, where negative value means improvement in DLQI. |
| Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | At weeks 4, 8, 12 and 16 | The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of Not at all, A little, A lot, Very much. The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined the percentage of patients with complete resolution of dermatology specific quality of life impact, as assessed by a total score of ≤ 1 (range: 0 - 30), where higher percentage indicates better improvement in DLQI. |
| Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | At weeks 1, 2, 4, 6, 8, 12 and 16 | In summary statistics for pharmacokinetic, concentration values below the lower limit of quantification (LLOQ) was set to zero. |
Countries
Australia, Canada, United States
Participant flow
Pre-assignment details
Participants were randomized at 60 sites in 3 countries, including Australia (N=6), United States (N=46) and Canada (N=8). A total of 194 participants (67% moderate and 33% severe hidradenitis suppurativa) were screened successfully and were randomized to 4 treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were randomly assigned to receive matching placebo in a 1/3 ratio of PF-06650833 or PF-06700841 or PF-06826647. | 48 |
| PF-06650833 400mg QD PF-06650833 400mg was administered orally once daily (QD) by tablet. | 47 |
| PF-06700841 45mg QD PF-06700841 45mg was administered orally once daily (QD) by tablet. | 52 |
| PF-06826647 400mg QD PF-06826647 400mg was administered orally once daily (QD) by tablet. | 47 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 3 | 7 |
| Overall Study | Lack of Efficacy | 1 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 | 5 | 1 |
| Overall Study | Non-Compliance With Study Drug | 0 | 0 | 1 | 1 |
| Overall Study | Other | 0 | 0 | 1 | 2 |
| Overall Study | Physician Decision | 1 | 0 | 1 | 0 |
| Overall Study | Pregnancy | 2 | 0 | 0 | 0 |
| Overall Study | Protocol Deviation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 10 | 3 | 5 |
Baseline characteristics
| Characteristic | Placebo | PF-06650833 400mg QD | PF-06700841 45mg QD | PF-06826647 400mg QD | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37.0 Years STANDARD_DEVIATION 8.95 | 39.9 Years STANDARD_DEVIATION 12.66 | 38.0 Years STANDARD_DEVIATION 11.76 | 36.6 Years STANDARD_DEVIATION 10.72 | 37.9 Years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 13 Participants | 7 Participants | 8 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants | 34 Participants | 43 Participants | 38 Participants | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 13 Participants | 18 Participants | 24 Participants | 14 Participants | 69 Participants |
| Race/Ethnicity, Customized Multiracial (Asian, White) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 32 Participants | 26 Participants | 26 Participants | 28 Participants | 112 Participants |
| Sex: Female, Male Female | 42 Participants | 34 Participants | 40 Participants | 35 Participants | 151 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 12 Participants | 12 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 47 | 0 / 52 | 0 / 47 |
| other Total, other adverse events | 6 / 48 | 10 / 47 | 14 / 52 | 18 / 47 |
| serious Total, serious adverse events | 0 / 48 | 2 / 47 | 0 / 52 | 2 / 47 |
Outcome results
Primary
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At week 16
Population: All participants randomized and received at least one dose of study intervention. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | 33.3 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | 34.0 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | 51.9 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)]. | 37.0 Percentage of participants |
Comparison: The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.p-value: 0.469690% CI: [-15.2, 16.7]MR weighting strategy
Comparison: The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.p-value: 0.029890% CI: [2.7, 34.6]MR weighting strategy
Comparison: The null hypothesis for primary efficacy analysis was that the percentage of participants achieving HiSCR response at Week 16 was the same for the active treatment (PF-06650833, PF-06700841 or PF-06826647) and placebo. The treatment was considered superior to control if the difference was statistically significant at the overall 1-sided 0.1 level.p-value: 0.360690% CI: [-12.6, 19.6]MR weighting strategy
Secondary
Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)].
The analysis of covariance (ANCOVA) model was implemented for statistical testing, which included terms of treatment group, the stratification factors, and the baseline value as the independent variable.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 1 | -1.94 Percent change |
| Placebo | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 12 | -32.52 Percent change |
| Placebo | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 8 | -36.26 Percent change |
| Placebo | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 2 | -22.29 Percent change |
| Placebo | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 16 | -34.96 Percent change |
| Placebo | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 4 | -26.46 Percent change |
| Placebo | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 6 | -33.05 Percent change |
| PF-06650833 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 12 | -39.06 Percent change |
| PF-06650833 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 6 | -25.96 Percent change |
| PF-06650833 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 4 | -30.98 Percent change |
| PF-06650833 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 8 | -24.76 Percent change |
| PF-06650833 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 16 | -24.11 Percent change |
| PF-06650833 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 2 | -34.81 Percent change |
| PF-06650833 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 1 | -13.92 Percent change |
| PF-06700841 45mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 6 | -47.62 Percent change |
| PF-06700841 45mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 1 | -17.00 Percent change |
| PF-06700841 45mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 2 | -25.15 Percent change |
| PF-06700841 45mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 4 | -44.00 Percent change |
| PF-06700841 45mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 8 | -52.41 Percent change |
| PF-06700841 45mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 12 | -49.70 Percent change |
| PF-06700841 45mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 16 | -52.58 Percent change |
| PF-06826647 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 4 | -30.38 Percent change |
| PF-06826647 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 16 | -44.37 Percent change |
| PF-06826647 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 12 | -52.51 Percent change |
| PF-06826647 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 2 | -27.79 Percent change |
| PF-06826647 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 1 | -19.39 Percent change |
| PF-06826647 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 8 | -51.33 Percent change |
| PF-06826647 400mg QD | Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)]. | Week 6 | -42.00 Percent change |
Comparison: Week 190% CI: [-26.16, 2.2]
Comparison: Week 190% CI: [-29.09, -1.04]
Comparison: Week 190% CI: [-31.86, -3.05]
Comparison: Week 290% CI: [-28.09, 3.05]
Comparison: Week 290% CI: [-18.22, 12.5]
Comparison: Week 290% CI: [-21.02, 10.03]
Comparison: Week 490% CI: [-22.96, 13.93]
Comparison: Week 490% CI: [-35.84, 0.77]
Comparison: Week 490% CI: [-22.85, 15]
Comparison: Week 690% CI: [-15.04, 29.22]
Comparison: Week 690% CI: [-37.08, 7.95]
Comparison: Week 690% CI: [-31.66, 13.76]
Comparison: Week 8p-value: 0.810890% CI: [-9.98, 32.98]ANCOVA
Comparison: Week 8p-value: 0.104390% CI: [-37.28, 4.98]ANCOVA
Comparison: Week 8p-value: 0.129690% CI: [-37.04, 6.9]ANCOVA
Comparison: Week 12p-value: 0.34590% CI: [-33.49, 20.42]ANCOVA
Comparison: Week 12p-value: 0.111990% CI: [-40.4, 6.04]ANCOVA
Comparison: Week 12p-value: 0.088590% CI: [-44.34, 4.37]ANCOVA
Comparison: Week 16p-value: 0.70590% CI: [-22.28, 43.98]ANCOVA
Comparison: Week 16p-value: 0.183390% CI: [-49.73, 14.48]ANCOVA
Comparison: Week 16p-value: 0.321390% CI: [-42.76, 23.94]ANCOVA
Secondary
Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of Not at all, A little, A lot, Very much. The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes.
Time frame: At weeks 4, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Absolute Score | 10.2 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Absolute Score | 10.8 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Absolute Score | 10.7 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Absolute Score | 9.5 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Absolute Score | 10.2 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Absolute Score | 9.9 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Absolute Score | 11.2 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Absolute Score | 10.6 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Absolute Score | 8.7 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Absolute Score | 9.6 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Absolute Score | 8.2 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Absolute Score | 9.6 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Absolute Score | 9.5 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Absolute Score | 10.8 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Absolute Score | 11.1 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Absolute Score | 10.5 Units on a scale |
Comparison: Week 490% CI: [-1.7, 2.6]
Comparison: Week 490% CI: [-2.7, 1.7]
Comparison: Week 490% CI: [-1.4, 3.2]
Comparison: Week 890% CI: [-2.7, 1.6]
Comparison: Week 890% CI: [-3.3, 1]
Comparison: Week 890% CI: [-2.2, 2.2]
Comparison: Week 1290% CI: [-3.2, 1.6]
Comparison: Week 1290% CI: [-4.3, 0.3]
Comparison: Week 1290% CI: [-2.6, 2.2]
Comparison: Week 1690% CI: [-0.7, 4.2]
Comparison: Week 1690% CI: [-3.6, 1.2]
Comparison: Week 1690% CI: [-2.4, 2.6]
Secondary
Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS)
The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | 5.67 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | 4.85 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | 5.10 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | 4.34 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | 6.98 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | 4.65 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | 4.77 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | 5.05 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | 6.94 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | 4.69 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | 4.38 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | 4.39 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | 4.77 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | 4.40 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | 4.86 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | 6.37 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | 7.34 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | 5.04 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | 5.55 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | 5.39 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | 5.66 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | 5.53 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | 4.28 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | 6.46 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | 7.38 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | 5.17 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | 4.75 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | 4.46 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | 6.69 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | 4.57 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | 5.46 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | 4.80 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | 4.59 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | 4.36 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | 4.79 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | 5.06 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | 4.46 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | 4.67 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | 6.82 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | 4.40 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | 4.69 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | 5.02 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | 4.44 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | 5.71 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | 5.47 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | 4.81 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | 5.16 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | 4.93 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | 4.86 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | 7.24 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | 5.66 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | 5.24 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | 5.01 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | 5.07 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | 6.77 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | 7.26 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | 5.12 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | 6.51 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | 4.78 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | 7.24 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | 4.45 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | 5.02 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | 5.08 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | 7.43 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | 5.43 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | 4.93 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | 4.81 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | 4.73 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | 4.70 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | 5.10 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | 6.00 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | 5.19 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | 4.69 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | 4.36 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | 4.20 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | 4.14 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | 3.60 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | 3.53 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | 5.37 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | 5.06 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | 4.61 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | 4.41 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | 4.45 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | 3.90 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | 3.80 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | 5.30 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | 4.70 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | 4.40 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | 4.35 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | 4.38 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | 3.87 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | 3.73 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | 4.98 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | 4.66 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | 4.24 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | 4.25 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | 4.32 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | 3.99 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | 4.03 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | 7.06 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | 6.55 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | 6.00 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | 5.86 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | 5.59 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | 5.43 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | 4.60 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | 4.60 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | 4.95 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | 4.66 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | 4.77 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | 4.69 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | 4.68 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | 5.07 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | 3.93 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | 6.37 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | 7.37 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | 4.41 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | 5.04 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | 6.58 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | 6.99 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | 4.65 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | 4.75 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | 5.00 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | 6.65 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | 5.35 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | 3.87 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | 4.83 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | 6.59 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | 4.35 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | 4.91 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | 4.91 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | 5.36 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | 5.63 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | 5.25 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | 4.89 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | 3.77 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | 4.30 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | 6.67 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | 4.97 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | 4.88 Units on a scale |
Comparison: Week 1-HSS0101-Pain At It's Worst90% CI: [-0.69, 0.29]
Comparison: Week 1-HSS0101-Pain At It's Worst90% CI: [-0.96, -0.01]
Comparison: Week 1-HSS0101-Pain At It's Worst90% CI: [-0.91, 0.06]
Comparison: Week 2-HSS0101-Pain At It's Worst90% CI: [-0.95, 0.35]
Comparison: Week 2-HSS0101-Pain At It's Worst90% CI: [-1.33, -0.08]
Comparison: Week 2-HSS0101-Pain At It's Worst90% CI: [-1.21, 0.08]
Comparison: Week 4-HSS0101-Pain At It's Worst90% CI: [-0.54, 1.05]
Comparison: Week 4-HSS0101-Pain At It's Worst90% CI: [-1.15, 0.37]
Comparison: Week 4-HSS0101-Pain At It's Worst90% CI: [-0.85, 0.73]
Comparison: Week 6-HSS0101-Pain At It's Worst90% CI: [-0.24, 1.49]
Comparison: Week 6-HSS0101-Pain At It's Worst90% CI: [-1.03, 0.64]
Comparison: Week 6-HSS0101-Pain At It's Worst90% CI: [-0.66, 1.08]
Comparison: Week 8-HSS0101-Pain At It's Worst90% CI: [-0.69, 1.16]
Comparison: Week 8-HSS0101-Pain At It's Worst90% CI: [-1.21, 0.57]
Comparison: Week 8-HSS0101-Pain At It's Worst90% CI: [-0.49, 1.38]
Comparison: Week 12-HSS0101-Pain At It's Worst90% CI: [-0.79, 1.12]
Comparison: Week 12-HSS0101-Pain At It's Worst90% CI: [-1.59, 0.23]
Comparison: Week 12-HSS0101-Pain At It's Worst90% CI: [-0.88, 1.03]
Comparison: Week 16-HSS0101-Pain At It's Worst90% CI: [-0.96, 1.13]
Comparison: Week 16-HSS0101-Pain At It's Worst90% CI: [-2.24, -0.25]
Comparison: Week 16-HSS0101-Pain At It's Worst90% CI: [-1.95, 0.13]
Comparison: Week 1-HSS0102-Tenderness At It's Worst90% CI: [-0.47, 0.48]
Comparison: Week 1-HSS0102-Tenderness At It's Worst90% CI: [-0.75, 0.18]
Comparison: Week 1-HSS0102-Tenderness At It's Worst90% CI: [-0.78, 0.17]
Comparison: Week 2-HSS0102-Tenderness At It's Worst90% CI: [-0.81, 0.38]
Comparison: Week 2-HSS0102-Tenderness At It's Worst90% CI: [-0.97, 0.18]
Comparison: Week 2-HSS0102-Tenderness At It's Worst90% CI: [-1.05, 0.14]
Comparison: Week 4-HSS0102-Tenderness At It's Worst90% CI: [-0.56, 1]
Comparison: Week 4-HSS0102-Tenderness At It's Worst90% CI: [-0.99, 0.49]
Comparison: Week 4-HSS0102-Tenderness At It's Worst90% CI: [-0.88, 0.67]
Comparison: Week 6-HSS0102-Tenderness At It's Worst90% CI: [-0.38, 1.34]
Comparison: Week 6-HSS0102-Tenderness At It's Worst90% CI: [-1.06, 0.6]
Comparison: Week 6-HSS0102-Tenderness At It's Worst90% CI: [-0.86, 0.87]
Comparison: Week 8-HSS0102-Tenderness At It's Worst90% CI: [-0.81, 0.99]
Comparison: Week 8-HSS0102-Tenderness At It's Worst90% CI: [-1.11, 0.62]
Comparison: Week 8-HSS0102-Tenderness At It's Worst90% CI: [-0.56, 1.25]
Comparison: Week 12-HSS0102-Tenderness At It's Worst90% CI: [-0.87, 0.97]
Comparison: Week 12-HSS0102-Tenderness At It's Worst90% CI: [-1.36, 0.38]
Comparison: Week 12-HSS0102-Tenderness At It's Worst90% CI: [-0.9, 0.93]
Comparison: Week 16-HSS0102-Tenderness At It's Worst90% CI: [-0.96, 1.04]
Comparison: Week 16-HSS0102-Tenderness At It's Worst90% CI: [-2.19, -0.29]
Comparison: Week 16-HSS0102-Tenderness At It's Worst90% CI: [-2.11, -0.11]
Comparison: Week 1-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.39, 0.49]
Comparison: Week 1-HSS0103-Swelling At It's Worst90% CI: [-0.57, 0.37]
Comparison: Week 1-HSS0103-Swelling At It's Worst90% CI: [-0.69, 0.22]
Comparison: Week 1-HSS0103-Swelling At It's Worst90% CI: [-0.94, 0.01]
Comparison: Week 2-HSS0103-Swelling At It's Worst90% CI: [-0.83, 0.35]
Comparison: Week 2-HSS0103-Swelling At It's Worst90% CI: [-1.03, 0.11]
Comparison: Week 2-HSS0103-Swelling At It's Worst90% CI: [-0.99, 0.19]
Comparison: Week 4-HSS0103-Swelling At It's Worst90% CI: [-0.58, 0.9]
Comparison: Week 4-HSS0103-Swelling At It's Worst90% CI: [-0.87, 0.53]
Comparison: Week 4-HSS0103-Swelling At It's Worst90% CI: [-0.65, 0.82]
Comparison: Week 6-HSS0103-Swelling At It's Worst90% CI: [-0.15, 1.54]
Comparison: Week 6-HSS0103-Swelling At It's Worst90% CI: [-0.83, 0.8]
Comparison: Week 6-HSS0103-Swelling At It's Worst90% CI: [-0.62, 1.08]
Comparison: Week 8-HSS0103-Swelling At It's Worst90% CI: [-0.55, 1.13]
Comparison: Week 8-HSS0103-Swelling At It's Worst90% CI: [-0.81, 0.81]
Comparison: Week 8-HSS0103-Swelling At It's Worst90% CI: [-0.35, 1.35]
Comparison: Week 12-HSS0103-Swelling At It's Worst90% CI: [-0.81, 0.95]
Comparison: Week 12-HSS0103-Swelling At It's Worst90% CI: [-1.3, 0.37]
Comparison: Week 12-HSS0103-Swelling At It's Worst90% CI: [-0.92, 0.84]
Comparison: Week 16-HSS0103-Swelling At It's Worst90% CI: [-0.75, 1.2]
Comparison: Week 16-HSS0103-Swelling At It's Worst90% CI: [-1.99, -0.13]
Comparison: Week 16-HSS0103-Swelling At It's Worst90% CI: [-1.99, -0.05]
Comparison: Week 1-HSS0104-Tiredness At It's Worst90% CI: [-0.27, 0.59]
Comparison: Week 1-HSS0104-Tiredness At It's Worst90% CI: [-0.99, -0.15]
Comparison: Week 1-HSS0104-Tiredness At It's Worst90% CI: [-0.35, 0.52]
Comparison: Week 2-HSS0104-Tiredness At It's Worst90% CI: [-0.54, 0.65]
Comparison: Week 2-HSS0104-Tiredness At It's Worst90% CI: [-1.01, 0.13]
Comparison: Week 2-HSS0104-Tiredness At It's Worst90% CI: [-0.33, 0.85]
Comparison: Week 4-HSS0104-Tiredness At It's Worst90% CI: [-0.83, 0.6]
Comparison: Week 4-HSS0104-Tiredness At It's Worst90% CI: [-1.49, -0.12]
Comparison: Week 4-HSS0104-Tiredness At It's Worst90% CI: [-0.86, 0.57]
Comparison: Week 6-HSS0104-Tiredness At It's Worst90% CI: [-0.76, 0.84]
Comparison: Week 6-HSS0104-Tiredness At It's Worst90% CI: [-1.29, 0.26]
Comparison: Week 6-HSS0104-Tiredness At It's Worst90% CI: [-0.68, 0.92]
Comparison: Week 8-HSS0104-Tiredness At It's Worst90% CI: [-0.96, 0.63]
Comparison: Week 8-HSS0104-Tiredness At It's Worst90% CI: [-1.31, 0.24]
Comparison: Week 8-HSS0104-Tiredness At It's Worst90% CI: [-0.69, 0.92]
Comparison: Week 12-HSS0104-Tiredness At It's Worst90% CI: [-1.21, 0.53]
Comparison: Week 12-HSS0104-Tiredness At It's Worst90% CI: [-1.64, 0.02]
Comparison: Week 12-HSS0104-Tiredness At It's Worst90% CI: [-0.72, 1.02]
Comparison: Week 16-HSS0104-Tiredness At It's Worst90% CI: [-0.7, 1.15]
Comparison: Week 16-HSS0104-Tiredness At It's Worst90% CI: [-1.44, 0.32]
Comparison: Week 16-HSS0104-Tiredness At It's Worst90% CI: [-0.83, 1.01]
Comparison: Week 1-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.75, 0.1]
Comparison: Week 1-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.46, 0.42]
Comparison: Week 2-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.65, 0.45]
Comparison: Week 2-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.33, -0.27]
Comparison: Week 2-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.91, 0.19]
Comparison: Week 4-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.36, 1]
Comparison: Week 4-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.59, -0.29]
Comparison: Week 4-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.97, 0.39]
Comparison: Week 6-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.2, 1.3]
Comparison: Week 6-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.41, 0.04]
Comparison: Week 6-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.85, 0.66]
Comparison: Week 8-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.96, 0.66]
Comparison: Week 8-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.89, -0.33]
Comparison: Week 8-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.13, 0.52]
Comparison: Week 12-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.86, 0.95]
Comparison: Week 12-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.73, -0.01]
Comparison: Week 12-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.78, 1.03]
Comparison: Week 16-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.6, 1.39]
Comparison: Week 16-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.9, 0]
Comparison: Week 16-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1, 0.99]
Secondary
Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Absolute Score | 22.9 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Absolute Score | 15.8 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Absolute Score | 14.9 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Absolute Score | 18.9 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Absolute Score | 16.0 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Absolute Score | 17.9 Units on a scale |
| Placebo | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Absolute Score | 19.7 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Absolute Score | 14.5 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Absolute Score | 18.1 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Absolute Score | 17.5 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Absolute Score | 15.9 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Absolute Score | 13.4 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Absolute Score | 18.0 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Absolute Score | 21.4 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Absolute Score | 14.9 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Absolute Score | 20.8 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Absolute Score | 18.8 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Absolute Score | 16.5 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Absolute Score | 15.0 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Absolute Score | 13.0 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Absolute Score | 12.0 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Absolute Score | 13.3 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Absolute Score | 13.4 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Absolute Score | 12.9 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Absolute Score | 19.0 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Absolute Score | 21.4 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Absolute Score | 11.1 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Absolute Score | 14.2 Units on a scale |
Comparison: Week 1 - Statistical Analysis (MI) - Absolute Score90% CI: [-5.9, 2.9]
Comparison: Week 1 - Statistical Analysis (MI) - Absolute Score90% CI: [-6.3, 2.2]
Comparison: Week 1 - Statistical Analysis (MI) - Absolute Score90% CI: [-5.9, 2.9]
Comparison: Week 2 - Statistical Analysis (MI) - Absolute Score90% CI: [-5.2, 3.3]
Comparison: Week 2 - Statistical Analysis (MI) - Absolute Score90% CI: [-4.3, 4.1]
Comparison: Week 2 - Statistical Analysis (MI) - Absolute Score90% CI: [-4.3, 4.3]
Comparison: Week 4 - Statistical Analysis (MI) - Absolute Score90% CI: [-4.5, 3.8]
Comparison: Week 4 - Statistical Analysis (MI) - Absolute Score90% CI: [-5.4, 2.8]
Comparison: Week 4 - Statistical Analysis (MI) - Absolute Score90% CI: [-8.8, -0.3]
Comparison: Week 6 - Statistical Analysis (MI) - Absolute Score90% CI: [-6.5, 3.3]
Comparison: Week 6 - Statistical Analysis (MI) - Absolute Score90% CI: [-9.5, 0.1]
Comparison: Week 6 - Statistical Analysis (MI) - Absolute Score90% CI: [-10.5, -0.4]
Comparison: Week 8 - Statistical Analysis (MI) - Absolute Scorep-value: 0.639390% CI: [-3.6, 5.6]ANCOVA
Comparison: Week 8 - Statistical Analysis (MI) - Absolute Scorep-value: 0.517890% CI: [-4.4, 4.6]ANCOVA
Comparison: Week 8 - Statistical Analysis (MI) - Absolute Scorep-value: 0.086490% CI: [-8.5, 0.8]ANCOVA
Comparison: Week 12 - Statistical Analysis (MI) - Absolute Scorep-value: 0.317290% CI: [-5.5, 3.1]ANCOVA
Comparison: Week 12 - Statistical Analysis (MI) - Absolute Scorep-value: 0.138490% CI: [-6.8, 1.4]ANCOVA
Comparison: Week 12 - Statistical Analysis (MI) - Absolute Scorep-value: 0.142790% CI: [-7.2, 1.5]ANCOVA
Comparison: Week 16 - Statistical Analysis (MI) - Absolute Scorep-value: 0.197590% CI: [-7.5, 2.4]ANCOVA
Comparison: Week 16 - Statistical Analysis (MI) - Absolute Scorep-value: 0.075590% CI: [-8.5, 0.6]ANCOVA
Comparison: Week 16 - Statistical Analysis (MI) - Absolute Scorep-value: 0.186990% CI: [-7.3, 2.2]ANCOVA
Secondary
Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of Not at all, A little, A lot, Very much. The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined a change from baseline in total score, where negative value means improvement in DLQI.
Time frame: At weeks 4, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Change from Baseline | -5.5 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Change from Baseline | -4.9 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Change from Baseline | -5.0 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Change from Baseline | -6.2 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Change from Baseline | -5.5 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Change from Baseline | -5.8 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Change from Baseline | -4.5 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Change from Baseline | -5.1 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Change from Baseline | -6.9 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Change from Baseline | -6.1 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Change from Baseline | -7.5 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Change from Baseline | -6.1 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 16-Change from Baseline | -6.2 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 8-Change from Baseline | -4.9 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 4-Change from Baseline | -4.6 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS) | Week 12-Change from Baseline | -5.2 Units on a scale |
Comparison: Week 490% CI: [-1.7, 2.6]
Comparison: Week 490% CI: [-2.7, 1.7]
Comparison: Week 490% CI: [-1.4, 3.2]
Comparison: Week 890% CI: [-2.7, 1.6]
Comparison: Week 890% CI: [-3.3, 1]
Comparison: Week 890% CI: [-2.2, 2.2]
Comparison: Week 1290% CI: [-3.2, 1.6]
Comparison: Week 1290% CI: [-4.3, 0.3]
Comparison: Week 1290% CI: [-2.6, 2.2]
Comparison: Week 1690% CI: [-0.7, 4.2]
Comparison: Week 1690% CI: [-3.6, 1.2]
Comparison: Week 1690% CI: [-2.4, 2.6]
Secondary
Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)
The Hidradenitis Suppurativa Symptom Items were 5 single items that assessed patient self-reported symptoms related to HS. The participants were asked to rate each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom. The symptoms assessed include: pain, tenderness, swelling, tiredness, and bother of lesion appearance. The higher the score, the worse the outcomes, ranging from 0 indicating no symptom experience and 10 indicating the worst possible symptom. These concepts were scored separately, and were not combined into a composite score. When using mixed effect model repeated measurement (MMRM) analysis, only observed data were used and missing data were not imputed.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | -0.19 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | -1.17 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | -0.49 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | -1.43 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | -0.59 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | -1.38 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | -0.82 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | -0.54 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | -0.63 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | -1.33 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | -1.38 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | -1.47 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | -1.09 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | -1.63 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | -0.73 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | -1.20 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | -0.23 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | -0.98 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | -0.04 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | -0.47 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | -0.37 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | -0.24 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | -1.59 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | -1.11 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | -0.19 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | -0.60 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | -1.12 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | -1.40 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | -0.88 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | -1.20 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | -0.56 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | -0.79 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | -1.00 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | -1.40 Units on a scale |
| Placebo | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | -0.98 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | -0.71 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | -1.13 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | -1.10 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | -0.75 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | -1.36 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | -0.90 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | -0.75 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | -1.42 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | 0.12 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | -0.39 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | -0.78 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | -0.43 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | -0.66 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | -1.01 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | -0.33 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | -0.36 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | -0.78 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | -0.86 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | -0.95 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | -0.80 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | -0.30 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | -0.90 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | -1.06 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | -1.24 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | -0.33 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | -1.57 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | -0.85 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | -0.94 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | -0.14 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | -0.34 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | -0.84 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | -0.78 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | -1.04 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | -1.17 Units on a scale |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | -0.77 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | -1.57 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | -0.67 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | -1.18 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | -1.51 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | -1.66 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | -1.72 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | -2.27 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | -2.34 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | -0.65 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | -0.96 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | -1.42 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | -1.61 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | -1.58 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | -2.12 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | -2.22 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | -0.47 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | -1.06 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | -1.37 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | -1.42 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | -1.38 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | -1.90 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | -2.04 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | -0.61 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | -0.93 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | -1.35 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | -1.33 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | -1.26 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | -1.60 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | -1.56 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | -0.51 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | -1.02 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | -1.56 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | -1.71 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | -1.98 Units on a scale |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | -2.14 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0103-Swelling At It's Worst | -1.17 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0101-Pain At It's Worst | -1.27 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0104-Tiredness At It's Worst | -0.64 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0103-Swelling At It's Worst | -1.11 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0103-Swelling At It's Worst | -1.00 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0101-Pain At It's Worst | -1.18 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0104-Tiredness At It's Worst | -0.90 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0103-Swelling At It's Worst | -0.70 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0102-Tenderness At It's Worst | -2.09 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0105-Bothered By Appearance HS Lesion | -1.20 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0105-Bothered By Appearance HS Lesion | -0.20 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0102-Tenderness At It's Worst | -1.61 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0102-Tenderness At It's Worst | -0.98 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0105-Bothered By Appearance HS Lesion | -0.99 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0105-Bothered By Appearance HS Lesion | -0.58 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0102-Tenderness At It's Worst | -1.37 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0102-Tenderness At It's Worst | -1.28 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0102-Tenderness At It's Worst | -1.02 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0105-Bothered By Appearance HS Lesion | -0.92 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0102-Tenderness At It's Worst | -0.67 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0101-Pain At It's Worst | -2.00 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0101-Pain At It's Worst | -1.04 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0105-Bothered By Appearance HS Lesion | -0.97 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0101-Pain At It's Worst | -1.51 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0101-Pain At It's Worst | -0.96 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 4-HSS0104-Tiredness At It's Worst | -0.68 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 2-HSS0104-Tiredness At It's Worst | -0.23 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0104-Tiredness At It's Worst | 0.04 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 1-HSS0101-Pain At It's Worst | -0.61 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 6-HSS0104-Tiredness At It's Worst | -0.70 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 16-HSS0103-Swelling At It's Worst | -2.00 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 12-HSS0103-Swelling At It's Worst | -1.47 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0105-Bothered By Appearance HS Lesion | -0.90 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0104-Tiredness At It's Worst | -0.62 Units on a scale |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS) | Week 8-HSS0103-Swelling At It's Worst | -0.88 Units on a scale |
Comparison: Week 1-HSS0101-Pain At It's Worst90% CI: [-0.69, 0.29]
Comparison: Week 1-HSS0101-Pain At It's Worst90% CI: [-0.96, -0.01]
Comparison: Week 1-HSS0101-Pain At It's Worst90% CI: [-0.91, 0.06]
Comparison: Week 2-HSS0101-Pain At It's Worst90% CI: [-0.95, 0.35]
Comparison: Week 2-HSS0101-Pain At It's Worst90% CI: [-1.33, -0.08]
Comparison: Week 2-HSS0101-Pain At It's Worst90% CI: [-1.21, 0.08]
Comparison: Week 4-HSS0101-Pain At It's Worst90% CI: [-0.54, 1.05]
Comparison: Week 4-HSS0101-Pain At It's Worst90% CI: [-1.15, 0.37]
Comparison: Week 4-HSS0101-Pain At It's Worst90% CI: [-0.85, 0.73]
Comparison: Week 6-HSS0101-Pain At It's Worst90% CI: [-0.24, 1.49]
Comparison: Week 6-HSS0101-Pain At It's Worst90% CI: [-1.03, 0.64]
Comparison: Week 2-HSS0102-Tenderness At It's Worst90% CI: [-0.97, 0.18]
Comparison: Week 2-HSS0102-Tenderness At It's Worst90% CI: [-1.05, 0.14]
Comparison: Week 6-HSS0101-Pain At It's Worst90% CI: [-0.66, 1.08]
Comparison: Week 8-HSS0101-Pain At It's Worst90% CI: [-0.69, 1.16]
Comparison: Week 8-HSS0101-Pain At It's Worst90% CI: [-1.21, 0.57]
Comparison: Week 8-HSS0101-Pain At It's Worst90% CI: [-0.49, 1.38]
Comparison: Week 12-HSS0101-Pain At It's Worst90% CI: [-0.79, 1.12]
Comparison: Week 12-HSS0101-Pain At It's Worst90% CI: [-1.59, 0.23]
Comparison: Week 12-HSS0101-Pain At It's Worst90% CI: [-0.88, 1.03]
Comparison: Week 16-HSS0101-Pain At It's Worst90% CI: [-0.96, 1.13]
Comparison: Week 16-HSS0101-Pain At It's Worst90% CI: [-2.24, -0.25]
Comparison: Week 16-HSS0101-Pain At It's Worst90% CI: [-1.95, 0.13]
Comparison: Week 1-HSS0102-Tenderness At It's Worst90% CI: [-0.47, 0.48]
Comparison: Week 1-HSS0102-Tenderness At It's Worst90% CI: [-0.75, 0.18]
Comparison: Week 1-HSS0102-Tenderness At It's Worst90% CI: [-0.78, 0.17]
Comparison: Week 2-HSS0102-Tenderness At It's Worst90% CI: [-0.81, 0.38]
Comparison: Week 4-HSS0102-Tenderness At It's Worst90% CI: [-0.56, 1]
Comparison: Week 4-HSS0102-Tenderness At It's Worst90% CI: [-0.99, 0.49]
Comparison: Week 4-HSS0102-Tenderness At It's Worst90% CI: [-0.88, 0.67]
Comparison: Week 6-HSS0102-Tenderness At It's Worst90% CI: [-0.38, 1.34]
Comparison: Week 6-HSS0102-Tenderness At It's Worst90% CI: [-1.06, 0.6]
Comparison: Week 6-HSS0102-Tenderness At It's Worst90% CI: [-0.86, 0.87]
Comparison: Week 8-HSS0102-Tenderness At It's Worst90% CI: [-0.81, 0.99]
Comparison: Week 8-HSS0102-Tenderness At It's Worst90% CI: [-1.11, 0.62]
Comparison: Week 8-HSS0102-Tenderness At It's Worst90% CI: [-0.56, 1.25]
Comparison: Week 12-HSS0102-Tenderness At It's Worst90% CI: [-0.87, 0.97]
Comparison: Week 12-HSS0102-Tenderness At It's Worst90% CI: [-1.36, 0.38]
Comparison: Week 12-HSS0102-Tenderness At It's Worst90% CI: [-0.9, 0.93]
Comparison: Week 16-HSS0102-Tenderness At It's Worst90% CI: [-0.96, 1.04]
Comparison: Week 16-HSS0102-Tenderness At It's Worst90% CI: [-2.19, -0.29]
Comparison: Week 16-HSS0102-Tenderness At It's Worst90% CI: [-2.11, -0.11]
Comparison: Week 1-HSS0103-Swelling At It's Worst90% CI: [-0.57, 0.37]
Comparison: Week 1-HSS0103-Swelling At It's Worst90% CI: [-0.69, 0.22]
Comparison: Week 1-HSS0103-Swelling At It's Worst90% CI: [-0.94, 0.01]
Comparison: Week 2-HSS0103-Swelling At It's Worst90% CI: [-0.83, 0.35]
Comparison: Week 2-HSS0103-Swelling At It's Worst90% CI: [-1.03, 0.11]
Comparison: Week 2-HSS0103-Swelling At It's Worst90% CI: [-0.99, 0.19]
Comparison: Week 4-HSS0103-Swelling At It's Worst90% CI: [-0.58, 0.9]
Comparison: Week 4-HSS0103-Swelling At It's Worst90% CI: [-0.87, 0.53]
Comparison: Week 4-HSS0103-Swelling At It's Worst90% CI: [-0.65, 0.82]
Comparison: Week 6-HSS0103-Swelling At It's Worst90% CI: [-0.15, 1.54]
Comparison: Week 6-HSS0103-Swelling At It's Worst90% CI: [-0.83, 0.8]
Comparison: Week 6-HSS0103-Swelling At It's Worst90% CI: [-0.62, 1.08]
Comparison: Week 8-HSS0103-Swelling At It's Worst90% CI: [-0.55, 1.13]
Comparison: Week 8-HSS0103-Swelling At It's Worst90% CI: [-0.81, 0.81]
Comparison: Week 8-HSS0103-Swelling At It's Worst90% CI: [-0.35, 1.35]
Comparison: Week 12-HSS0103-Swelling At It's Worst90% CI: [-0.81, 0.95]
Comparison: Week 12-HSS0103-Swelling At It's Worst90% CI: [-1.3, 0.37]
Comparison: Week 12-HSS0103-Swelling At It's Worst90% CI: [-0.92, 0.84]
Comparison: Week 16-HSS0103-Swelling At It's Worst90% CI: [-0.75, 1.2]
Comparison: Week 16-HSS0103-Swelling At It's Worst90% CI: [-1.99, -0.13]
Comparison: Week 16-HSS0103-Swelling At It's Worst90% CI: [-1.99, -0.05]
Comparison: Week 1-HSS0104-Tiredness At It's Worst90% CI: [-0.27, 0.59]
Comparison: Week 1-HSS0104-Tiredness At It's Worst90% CI: [-0.99, -0.15]
Comparison: Week 1-HSS0104-Tiredness At It's Worst90% CI: [-0.35, 0.52]
Comparison: Week 2-HSS0104-Tiredness At It's Worst90% CI: [-0.54, 0.65]
Comparison: Week 2-HSS0104-Tiredness At It's Worst90% CI: [-1.01, 0.13]
Comparison: Week 2-HSS0104-Tiredness At It's Worst90% CI: [-0.33, 0.85]
Comparison: Week 4-HSS0104-Tiredness At It's Worst90% CI: [-0.83, 0.6]
Comparison: Week 4-HSS0104-Tiredness At It's Worst90% CI: [-1.49, -0.12]
Comparison: Week 4-HSS0104-Tiredness At It's Worst90% CI: [-0.86, 0.57]
Comparison: Week 6-HSS0104-Tiredness At It's Worst90% CI: [-0.76, 0.84]
Comparison: Week 6-HSS0104-Tiredness At It's Worst90% CI: [-1.29, 0.26]
Comparison: Week 6-HSS0104-Tiredness At It's Worst90% CI: [-0.68, 0.92]
Comparison: Week 8-HSS0104-Tiredness At It's Worst90% CI: [-0.96, 0.63]
Comparison: Week 8-HSS0104-Tiredness At It's Worst90% CI: [-1.31, 0.24]
Comparison: Week 8-HSS0104-Tiredness At It's Worst90% CI: [-0.69, 0.92]
Comparison: Week 12-HSS0104-Tiredness At It's Worst90% CI: [-1.21, 0.53]
Comparison: Week 12-HSS0104-Tiredness At It's Worst90% CI: [-1.64, 0.02]
Comparison: Week 12-HSS0104-Tiredness At It's Worst90% CI: [-0.72, 1.02]
Comparison: Week 16-HSS0104-Tiredness At It's Worst90% CI: [-0.7, 1.15]
Comparison: Week 16-HSS0104-Tiredness At It's Worst90% CI: [-1.44, 0.32]
Comparison: Week 16-HSS0104-Tiredness At It's Worst90% CI: [-0.83, 1.01]
Comparison: Week 1-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.39, 0.49]
Comparison: Week 1-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.75, 0.1]
Comparison: Week 1-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.46, 0.42]
Comparison: Week 2-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.65, 0.45]
Comparison: Week 2-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.33, -0.27]
Comparison: Week 2-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.91, 0.19]
Comparison: Week 4-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.36, 1]
Comparison: Week 4-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.59, -0.29]
Comparison: Week 4-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.97, 0.39]
Comparison: Week 6-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.2, 1.3]
Comparison: Week 6-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.41, 0.04]
Comparison: Week 6-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.85, 0.66]
Comparison: Week 8-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.96, 0.66]
Comparison: Week 8-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.89, -0.33]
Comparison: Week 8-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.13, 0.52]
Comparison: Week 12-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.86, 0.95]
Comparison: Week 12-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.73, -0.01]
Comparison: Week 12-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.78, 1.03]
Comparison: Week 16-HSS0105-Bothered By Appearance HS Lesion90% CI: [-0.6, 1.39]
Comparison: Week 16-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1.9, 0]
Comparison: Week 16-HSS0105-Bothered By Appearance HS Lesion90% CI: [-1, 0.99]
Secondary
Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Pain at its Worst | -0.23 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Pain at its Worst | -1.80 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Pain at its Worst | -1.56 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Pain at its Worst | -0.52 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Pain at its Worst | -1.44 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Pain at its Worst | -1.22 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Pain at its Worst | -1.55 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Pain at its Worst | -1.74 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Pain at its Worst | -1.06 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Pain at its Worst | -1.15 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Pain at its Worst | -1.40 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Pain at its Worst | -1.35 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Pain at its Worst | -0.84 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Pain at its Worst | -0.54 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Pain at its Worst | -1.97 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Pain at its Worst | -0.68 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Pain at its Worst | -1.07 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Pain at its Worst | -1.67 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Pain at its Worst | -1.95 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Pain at its Worst | -2.37 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Pain at its Worst | -2.51 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Pain at its Worst | -1.19 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Pain at its Worst | -2.01 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Pain at its Worst | -1.80 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Pain at its Worst | -0.91 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Pain at its Worst | -0.71 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Pain at its Worst | -1.43 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Pain at its Worst | -1.43 Percent change |
Comparison: Week 1 Pain at its Worstp-value: 0.153690% CI: [-0.8, 0.19]ANCOVA
Comparison: Week 1 Pain at its Worstp-value: 0.058190% CI: [-0.93, 0.02]ANCOVA
Comparison: Week 1 Pain at its Worstp-value: 0.053290% CI: [-0.98, 0.01]ANCOVA
Comparison: Week 2 Pain at its Worstp-value: 0.200790% CI: [-0.95, 0.31]ANCOVA
Comparison: Week 2 Pain at its Worstp-value: 0.069490% CI: [-1.16, 0.06]ANCOVA
Comparison: Week 2 Pain at its Worstp-value: 0.150990% CI: [-1.02, 0.23]ANCOVA
Comparison: Week 4 Pain at its Worstp-value: 0.566390% CI: [-0.64, 0.78]ANCOVA
Comparison: Week 4 Pain at its Worstp-value: 0.139690% CI: [-1.13, 0.23]ANCOVA
Comparison: Week 4 Pain at its Worstp-value: 0.522790% CI: [-0.69, 0.74]ANCOVA
Comparison: Week 6 Pain at its Worstp-value: 0.865690% CI: [-0.24, 1.24]ANCOVA
Comparison: Week 6 Pain at its Worstp-value: 0.167190% CI: [-1.13, 0.29]ANCOVA
Comparison: Week 6 Pain at its Worstp-value: 0.606390% CI: [-0.62, 0.86]ANCOVA
Comparison: Week 8 Pain at its Worstp-value: 0.640290% CI: [-0.59, 0.92]ANCOVA
Comparison: Week 8 Pain at its Worstp-value: 0.191690% CI: [-1.11, 0.34]ANCOVA
Comparison: Week 8 Pain at its Worstp-value: 0.611990% CI: [-0.62, 0.88]ANCOVA
Comparison: Week 12 Pain at its Worstp-value: 0.556890% CI: [-0.68, 0.8]ANCOVA
Comparison: Week 12 Pain at its Worstp-value: 0.097690% CI: [-1.27, 0.15]ANCOVA
Comparison: Week 12 Pain at its Worstp-value: 0.500190% CI: [-0.74, 0.74]ANCOVA
Comparison: Week 16 Pain at its Worstp-value: 0.58190% CI: [-0.65, 0.83]ANCOVA
Comparison: Week 16 Pain at its Worstp-value: 0.007990% CI: [-1.8, -0.34]ANCOVA
Comparison: Week 16 Pain at its Worstp-value: 0.106890% CI: [-1.31, 0.18]ANCOVA
Secondary
Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Average Pain | -0.19 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Average Pain | -1.68 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Average Pain | -1.56 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Average Pain | -0.49 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Average Pain | -1.40 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Average Pain | -1.22 Percent change |
| Placebo | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Average Pain | -1.49 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Average Pain | -1.71 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Average Pain | -0.98 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Average Pain | -1.10 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Average Pain | -1.35 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Average Pain | -1.37 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Average Pain | -0.77 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Average Pain | -0.44 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Average Pain | -1.92 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Average Pain | -0.62 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Average Pain | -0.94 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Average Pain | -1.73 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Average Pain | -1.88 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Average Pain | -2.25 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Average Pain | -2.29 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 4-Average Pain | -1.02 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 16-Average Pain | -1.77 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 12-Average Pain | -1.53 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 2-Average Pain | -0.66 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 1-Average Pain | -0.50 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 8-Average Pain | -1.30 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI) | Week 6-Average Pain | -1.29 Percent change |
Comparison: Week 6 Average Painp-value: 0.150290% CI: [-1.11, 0.25]ANCOVA
Comparison: Week 1 Average Painp-value: 0.189890% CI: [-0.72, 0.22]ANCOVA
Comparison: Week 1 Average Painp-value: 0.056290% CI: [-0.88, 0.02]ANCOVA
Comparison: Week 1 Average Painp-value: 0.138290% CI: [-0.78, 0.16]ANCOVA
Comparison: Week 2 Average Painp-value: 0.203990% CI: [-0.85, 0.28]ANCOVA
Comparison: Week 2 Average Painp-value: 0.085590% CI: [-1, 0.09]ANCOVA
Comparison: Week 2 Average Painp-value: 0.308990% CI: [-0.74, 0.39]ANCOVA
Comparison: Week 4 Average Painp-value: 0.612490% CI: [-0.55, 0.79]ANCOVA
Comparison: Week 4 Average Painp-value: 0.100390% CI: [-1.15, 0.14]ANCOVA
Comparison: Week 4 Average Painp-value: 0.687590% CI: [-0.47, 0.87]ANCOVA
Comparison: Week 6 Average Painp-value: 0.883390% CI: [-0.19, 1.21]ANCOVA
Comparison: Week 6 Average Painp-value: 0.678890% CI: [-0.5, 0.9]ANCOVA
Comparison: Week 8 Average Painp-value: 0.683590% CI: [-0.51, 0.94]ANCOVA
Comparison: Week 8 Average Painp-value: 0.223790% CI: [-1.02, 0.38]ANCOVA
Comparison: Week 8 Average Painp-value: 0.723490% CI: [-0.46, 0.98]ANCOVA
Comparison: Week 12 Average Painp-value: 0.477390% CI: [-0.72, 0.67]ANCOVA
Comparison: Week 12 Average Painp-value: 0.081890% CI: [-1.25, 0.1]ANCOVA
Comparison: Week 12 Average Painp-value: 0.639790% CI: [-0.55, 0.85]ANCOVA
Comparison: Week 16 Average Painp-value: 0.532190% CI: [-0.67, 0.74]ANCOVA
Comparison: Week 16 Average Painp-value: 0.016790% CI: [-1.59, -0.2]ANCOVA
Comparison: Week 16 Average Painp-value: 0.196390% CI: [-1.09, 0.34]ANCOVA
Secondary
Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).
The IHS4 score was calculated by the number of nodules, the number of abscesses, and the number of draining tunnels. IHS4 score = (number of nodules × 1) + (number of abscesses × 2) + {number of draining tunnels (fistulae/sinuses) × 4}. Confidence interval (CI) was calculated using Blyth-Still-Casella method. Lower IHS4 absolute scores mean a better outcome.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Percent Change from Baseline | -7.26 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Percent Change from Baseline | -36.46 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Percent Change from Baseline | -41.30 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Percent Change from Baseline | -26.58 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Percent Change from Baseline | -37.84 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Percent Change from Baseline | -32.64 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Percent Change from Baseline | -30.57 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Percent Change from Baseline | -43.24 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Percent Change from Baseline | -34.10 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Percent Change from Baseline | -33.10 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Percent Change from Baseline | -35.51 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Percent Change from Baseline | -43.47 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Percent Change from Baseline | -30.87 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Percent Change from Baseline | -10.91 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Percent Change from Baseline | -46.83 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Percent Change from Baseline | -21.02 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Percent Change from Baseline | -28.63 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Percent Change from Baseline | -40.71 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Percent Change from Baseline | -47.12 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Percent Change from Baseline | -53.03 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Percent Change from Baseline | -52.64 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 4 - Statistical Analysis (MI) - Percent Change from Baseline | -38.70 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 16 - Statistical Analysis (MI) - Percent Change from Baseline | -46.16 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 12 - Statistical Analysis (MI) - Percent Change from Baseline | -50.11 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 2 - Statistical Analysis (MI) - Percent Change from Baseline | -26.41 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 1 - Statistical Analysis (MI) - Percent Change from Baseline | -24.77 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 8 - Statistical Analysis (MI) - Percent Change from Baseline | -52.64 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI). | Week 6 - Statistical Analysis (MI) - Percent Change from Baseline | -43.09 Percent change |
Comparison: Week 1 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-17.9, 10.59]
Comparison: Week 1 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-28.16, 0.62]
Comparison: Week 1 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-31.91, -3.12]
Comparison: Week 2 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-20.91, 12.33]
Comparison: Week 2 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-18.34, 14.24]
Comparison: Week 2 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-16.34, 16.68]
Comparison: Week 4 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-17.29, 16.36]
Comparison: Week 4 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-24.77, 8.63]
Comparison: Week 4 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-23.35, 11.22]
Comparison: Week 6 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-23.71, 16.63]
Comparison: Week 6 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-36.84, 4.32]
Comparison: Week 6 - Statistical Analysis (MI) - Percent Change from Baseline90% CI: [-33.27, 8.22]
Comparison: Week 8 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.790% CI: [-12.38, 23.96]ANCOVA
Comparison: Week 8 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.296590% CI: [-23.7, 12.08]ANCOVA
Comparison: Week 8 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.156890% CI: [-29.83, 7.17]ANCOVA
Comparison: Week 12 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.267290% CI: [-24.73, 11.17]ANCOVA
Comparison: Week 12 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.057690% CI: [-33.87, 0.73]ANCOVA
Comparison: Week 12 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.119790% CI: [-32.74, 5.44]ANCOVA
Comparison: Week 16 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.338890% CI: [-27.91, 16.65]ANCOVA
Comparison: Week 16 - Statistical Analysis (MI) - Percent Change from Baselinep-value: 0.137690% CI: [-37.12, 7.51]ANCOVA
Comparison: Week 16p-value: 0.274190% CI: [-31.12, 14.48]ANCOVA
Secondary
Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention with baseline ≥3 scores were included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Pain at its Worst | -1.45 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Pain at its Worst | -26.04 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Pain at its Worst | -23.53 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Pain at its Worst | -7.49 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Pain at its Worst | -22.34 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Pain at its Worst | -18.81 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Pain at its Worst | -21.80 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Pain at its Worst | -25.38 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Pain at its Worst | -13.86 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Pain at its Worst | -15.56 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Pain at its Worst | -20.70 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Pain at its Worst | -19.77 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Pain at its Worst | -13.15 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Pain at its Worst | -8.89 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Pain at its Worst | -32.89 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Pain at its Worst | -11.97 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Pain at its Worst | -19.40 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Pain at its Worst | -26.63 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Pain at its Worst | -34.83 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Pain at its Worst | -41.35 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Pain at its Worst | -43.88 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Pain at its Worst | -19.98 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Pain at its Worst | -34.87 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Pain at its Worst | -32.43 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Pain at its Worst | -19.19 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Pain at its Worst | -15.58 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Pain at its Worst | -23.37 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Pain at its Worst | -21.76 Percent change |
Comparison: Week 2 Pain at its Worstp-value: 0.249690% CI: [-19.45, 8.12]ANCOVA
Comparison: Week 1 Pain at its Worstp-value: 0.132190% CI: [-18.39, 3.52]ANCOVA
Comparison: Week 1 Pain at its Worstp-value: 0.047790% CI: [-20.9, -0.14]ANCOVA
Comparison: Week 1 Pain at its Worstp-value: 0.013490% CI: [-24.62, -3.63]ANCOVA
Comparison: Week 2 Pain at its Worstp-value: 0.067590% CI: [-25.03, 1.2]ANCOVA
Comparison: Week 2 Pain at its Worstp-value: 0.07390% CI: [-24.96, 1.54]ANCOVA
Comparison: Week 4 Pain at its Worstp-value: 0.642690% CI: [-11.38, 17.88]ANCOVA
Comparison: Week 4 Pain at its Worstp-value: 0.177690% CI: [-21.73, 6.09]ANCOVA
Comparison: Week 4 Pain at its Worstp-value: 0.445890% CI: [-15.28, 12.94]ANCOVA
Comparison: Week 6 Pain at its Worstp-value: 0.796990% CI: [-7.79, 23.68]ANCOVA
Comparison: Week 6 Pain at its Worstp-value: 0.11290% CI: [-26.09, 3.91]ANCOVA
Comparison: Week 6 Pain at its Worstp-value: 0.502190% CI: [-15.06, 15.16]ANCOVA
Comparison: Week 8 Pain at its Worstp-value: 0.619790% CI: [-12.46, 18.12]ANCOVA
Comparison: Week 8 Pain at its Worstp-value: 0.100390% CI: [-25.81, 3.22]ANCOVA
Comparison: Week 8 Pain at its Worstp-value: 0.50790% CI: [-14.5, 14.81]ANCOVA
Comparison: Week 12 Pain at its Worstp-value: 0.528390% CI: [-14.74, 16.08]ANCOVA
Comparison: Week 12 Pain at its Worstp-value: 0.043190% CI: [-29.98, -0.63]ANCOVA
Comparison: Week 12 Pain at its Worstp-value: 0.239590% CI: [-21.22, 8.45]ANCOVA
Comparison: Week 16 Pain at its Worstp-value: 0.605490% CI: [-13.25, 18.39]ANCOVA
Comparison: Week 16 Pain at its Worstp-value: 0.010690% CI: [-36.91, -6.17]ANCOVA
Comparison: Week 16 Pain at its Worstp-value: 0.08990% CI: [-27.84, 2.77]ANCOVA
Secondary
Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)
Patient Global Assessment Skin Pain Numeric Rating Scale was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). These two concepts were measured within the same instrument, but were scored separately. There was no composite score for this endpoint. The higher the score, the worse the outcomes, ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). Subscales were not combined. The ANCOVA model was fitted. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention with baseline ≥3 scores were included.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Average Pain | -2.47 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Average Pain | -30.85 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Average Pain | -30.75 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Average Pain | -11.24 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Average Pain | -27.83 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Average Pain | -24.04 Percent change |
| Placebo | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Average Pain | -28.65 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Average Pain | -28.50 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Average Pain | -14.86 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Average Pain | -16.00 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Average Pain | -21.78 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Average Pain | -23.80 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Average Pain | -13.39 Percent change |
| PF-06650833 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Average Pain | -8.64 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Average Pain | -38.04 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Average Pain | -13.53 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Average Pain | -21.59 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Average Pain | -33.01 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Average Pain | -39.59 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Average Pain | -45.24 Percent change |
| PF-06700841 45mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Average Pain | -46.21 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 4-Average Pain | -18.67 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 16-Average Pain | -31.92 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 12-Average Pain | -30.42 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 2-Average Pain | -13.49 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 1-Average Pain | -8.81 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 8-Average Pain | -22.11 Percent change |
| PF-06826647 400mg QD | Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI) | Week 6-Average Pain | -22.60 Percent change |
Comparison: Week 1 Average Painp-value: 0.150590% CI: [-15.98, 3.64]ANCOVA
Comparison: Week 1 Average Painp-value: 0.023390% CI: [-20.19, -1.92]ANCOVA
Comparison: Week 1 Average Painp-value: 0.142390% CI: [-16.09, 3.41]ANCOVA
Comparison: Week 2 Average Painp-value: 0.382790% CI: [-14, 9.7]ANCOVA
Comparison: Week 2 Average Painp-value: 0.062490% CI: [-21.44, 0.74]ANCOVA
Comparison: Week 2 Average Painp-value: 0.377190% CI: [-14.04, 9.55]ANCOVA
Comparison: Week 4 Average Painp-value: 0.824790% CI: [-6.13, 22.21]ANCOVA
Comparison: Week 4 Average Painp-value: 0.133790% CI: [-22.28, 4.33]ANCOVA
Comparison: Week 4 Average Painp-value: 0.735790% CI: [-8.65, 19.39]ANCOVA
Comparison: Week 6 Average Painp-value: 0.937790% CI: [-0.98, 28.55]ANCOVA
Comparison: Week 6 Average Painp-value: 0.133290% CI: [-23.29, 4.51]ANCOVA
Comparison: Week 6 Average Painp-value: 0.751490% CI: [-8.6, 20.7]ANCOVA
Comparison: Week 8 Average Painp-value: 0.843390% CI: [-5.67, 23.62]ANCOVA
Comparison: Week 8 Average Painp-value: 0.146190% CI: [-22.64, 4.96]ANCOVA
Comparison: Week 8 Average Painp-value: 0.836490% CI: [-5.86, 23.15]ANCOVA
Comparison: Week 12 Average Painp-value: 0.608590% CI: [-11.68, 16.37]ANCOVA
Comparison: Week 12 Average Painp-value: 0.036590% CI: [-27.58, -1.19]ANCOVA
Comparison: Week 12 Average Painp-value: 0.520190% CI: [-13.5, 14.36]ANCOVA
Comparison: Week 16 Average Painp-value: 0.681390% CI: [-10.05, 18.12]ANCOVA
Comparison: Week 16 Average Painp-value: 0.012890% CI: [-31.91, -4.84]ANCOVA
Comparison: Week 16 Average Painp-value: 0.318190% CI: [-18.3, 10.12]ANCOVA
Secondary
Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)
Laboratory test abnormalities included hematology, chemistry, urinalysis and biomarker.
Time frame: Up to 20 weeks
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: hemoglobin (g/dL) <0.8x lower limit of normal (LLN) | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Hematocrit (%) <0.8x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Erythrocytes (10^6/mm^3) <0.8x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) <0.9x LLN | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) >1.1x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9x LLN | 5 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9x LLN | 6 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) <0.9x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) >1.1x ULN | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) <0.5x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) >1.75x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) <0.6x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) >1.5x ULN | 4 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) <0.8x LLN | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) >1.2x ULN | 5 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) <0.8x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) >1.2x ULN | 8 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Basophils (10^3/mm^3) >1.2x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Eosinophils (10^3/mm^3) >1.2x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Monocytes (10^3/mm^3) >1.2x ULN | 2 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Aspartate Aminotransferase (U/L) >3.0x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alanine Aminotransferase (U/L) >3.0x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) <0.8x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) >1.2x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) <0.8x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) >1.2x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urate (mg/dL) >1.2x ULN | 3 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Cholesterol (mg/dL) >1.3x ULN | 2 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: HDL Cholesterol (mg/dL) <0.8x LLN | 10 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: LDL Cholesterol (mg/dL) >1.2x ULN | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Triglycerides (mg/dL) >1.3x ULN | 5 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) <0.95x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) >1.05x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) <0.9x LLN | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) >1.1x ULN | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) <0.9x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) >1.1x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) <0.9x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) >1.1x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) <0.9x LLN | 10 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) >1.1x ULN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) <0.6x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) >1.5x ULN | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatine Kinase (U/L) >2.0x ULN | 6 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) <0.6x LLN | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) >1.5x ULN | 4 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH <4.5 | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH >8 | 2 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Glucose (mg/dL) ≥1 | 4 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Ketones (mg/dL) ≥1 | 9 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Protein (mg/dL) ≥1 | 32 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Hemoglobin ≥1 | 23 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Urobilinogen (EU/dL) ≥1 | 3 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Bilirubin ≥1 | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Nitrite ≥1 | 3 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Leukocyte Esterase ≥1 | 10 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Erythrocytes (/HPF) ≥20 | 4 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Granular Casts (/LPF) >1 | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Hyaline Casts (/LPF) >1 | 1 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: RBC Casts (/LPF) >1 | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: WBC Casts (/LPF) >1 | 0 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Bacteria (/HPF) >20 | 6 Participants |
| Placebo | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Biomarker: C Reactive Protein (mg/dL) >1.1x ULN | 37 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) <0.5x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) >1.5x ULN | 5 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Basophils (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: LDL Cholesterol (mg/dL) >1.2x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Aspartate Aminotransferase (U/L) >3.0x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) <0.6x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Hyaline Casts (/LPF) >1 | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Triglycerides (mg/dL) >1.3x ULN | 4 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) <0.8x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatine Kinase (U/L) >2.0x ULN | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) >1.1x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) <0.95x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Glucose (mg/dL) ≥1 | 6 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) >1.5x ULN | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Leukocyte Esterase ≥1 | 5 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) >1.05x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alanine Aminotransferase (U/L) >3.0x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) >1.2x ULN | 3 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) <0.9x LLN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) <0.9x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) >1.1x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Granular Casts (/LPF) >1 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) >1.1x ULN | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: WBC Casts (/LPF) >1 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) <0.9x LLN | 10 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Bacteria (/HPF) >20 | 6 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) <0.9x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Erythrocytes (/HPF) ≥20 | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) >1.1x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) >1.5x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) <0.9x LLN | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: RBC Casts (/LPF) >1 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Urobilinogen (EU/dL) ≥1 | 4 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Ketones (mg/dL) ≥1 | 6 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Eosinophils (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) >1.2x ULN | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9x LLN | 3 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) <0.6x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH >8 | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Biomarker: C Reactive Protein (mg/dL) >1.1x ULN | 29 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Monocytes (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9x LLN | 5 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Bilirubin ≥1 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urea Nitrogen (mg/dL) >1.3x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) <0.8x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) >1.1x ULN | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) >1.75x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Hemoglobin ≥1 | 9 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) <0.9x LLN | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Erythrocytes (10^6/mm^3) <0.8x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urate (mg/dL) >1.2x ULN | 3 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH <4.5 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Hematocrit (%) <0.8x LLN | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Cholesterol (mg/dL) >1.3x ULN | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Protein (mg/dL) ≥1 | 30 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: hemoglobin (g/dL) <0.8x lower limit of normal (LLN) | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Nitrite ≥1 | 4 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: HDL Cholesterol (mg/dL) <0.8x LLN | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Aspartate Aminotransferase (U/L) >3.0x ULN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) <0.8x LLN | 3 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) >1.2x ULN | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Protein (mg/dL) ≥1 | 29 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Basophils (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Eosinophils (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Monocytes (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Hemoglobin ≥1 | 16 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alanine Aminotransferase (U/L) >3.0x ULN | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Urobilinogen (EU/dL) ≥1 | 7 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: WBC Casts (/LPF) >1 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Bilirubin ≥1 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatinine (mg/dL) >1.3x ULN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urate (mg/dL) >1.2x ULN | 4 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Cholesterol (mg/dL) >1.3x ULN | 4 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: HDL Cholesterol (mg/dL) <0.8x LLN | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Nitrite ≥1 | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: LDL Cholesterol (mg/dL) >1.2x ULN | 3 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Triglycerides (mg/dL) >1.3x ULN | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Biomarker: C Reactive Protein (mg/dL) >1.1x ULN | 37 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) <0.95x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) >1.05x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Leukocyte Esterase ≥1 | 9 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) <0.9x LLN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) >1.1x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) <0.9x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) >1.1x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Erythrocytes (/HPF) ≥20 | 5 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Bacteria (/HPF) >20 | 5 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) <0.9x LLN | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) >1.1x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Granular Casts (/LPF) >1 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) >1.5x ULN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatine Kinase (U/L) >2.0x ULN | 18 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) <0.6x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Hyaline Casts (/LPF) >1 | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) >1.5x ULN | 3 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: hemoglobin (g/dL) <0.8x lower limit of normal (LLN) | 4 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Hematocrit (%) <0.8x LLN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Erythrocytes (10^6/mm^3) <0.8x LLN | 3 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH <4.5 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) <0.9x LLN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) >1.1x ULN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9x LLN | 7 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH >8 | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9x LLN | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) <0.9x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) >1.1x ULN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Glucose (mg/dL) ≥1 | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) <0.5x LLN | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) >1.75x ULN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: RBC Casts (/LPF) >1 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) <0.6x LLN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) >1.5x ULN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Ketones (mg/dL) ≥1 | 8 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) <0.8x LLN | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) >1.2x ULN | 7 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) >1.5x ULN | 5 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Cholesterol (mg/dL) >1.3x ULN | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) <0.5x LLN | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: hemoglobin (g/dL) <0.8x lower limit of normal (LLN) | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Hyaline Casts (/LPF) >1 | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: WBC Casts (/LPF) >1 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Glucose (mg/dL) ≥1 | 4 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Hematocrit (%) <0.8x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urate (mg/dL) >1.2x ULN | 6 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Bilirubin ≥1 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Monocytes (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Erythrocytes (10^6/mm^3) <0.8x LLN | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) >1.2x ULN | 4 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Platelets (10^3/mm^3) >1.75x ULN | 3 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) <0.9x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH <4.5 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Urea Nitrogen (mg/dL) >1.3x ULN | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Lymphocytes (10^3/mm^3) <0.8x LLN | 3 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Volume (um^3) >1.1x ULN | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Biomarker: C Reactive Protein (mg/dL) >1.1x ULN | 30 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Eosinophils (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) <0.9x LLN | 5 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Urobilinogen (EU/dL) ≥1 | 5 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Ketones (mg/dL) ≥1 | 12 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) <0.6x LLN | 3 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Protein (mg/dL) ≥1 | 32 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9x LLN | 6 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: pH >8 | 5 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Basophils (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) >1.1x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Erythrocytes (/HPF) ≥20 | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Chloride (mEq/L) <0.9x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Alanine Aminotransferase (U/L) >3.0x ULN | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) >1.1x ULN | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) <0.8x LLN | 8 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) <0.9x LLN | 13 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Leukocyte Esterase ≥1 | 6 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Potassium (mEq/L) <0.9x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) <0.9x LLN | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bicarbonate (mEq/L) >1.1x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: URINE Hemoglobin ≥1 | 10 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) >1.05x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Aspartate Aminotransferase (U/L) >3.0x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Granular Casts (/LPF) >1 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Sodium (mEq/L) <0.95x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Leukocytes (10^3/mm^3) >1.5x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose (mg/dL) >1.5x ULN | 3 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Bacteria (/HPF) >20 | 4 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Triglycerides (mg/dL) >1.3x ULN | 7 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Mean Platelet Volume (fL) >1.1x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Creatine Kinase (U/L) >2.0x ULN | 20 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: Nitrite ≥1 | 3 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: LDL Cholesterol (mg/dL) >1.2x ULN | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Urinalysis: RBC Casts (/LPF) >1 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Glucose -FASTING (mg/dL) <0.6x LLN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Clinical Chemistry: HDL Cholesterol (mg/dL) <0.8x LLN | 5 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set) | Hematology: Neutrophils (10^3/mm^3) >1.2x ULN | 4 Participants |
Secondary
Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)
ECG parameters included QT interval, QTc interval, PR interval, and QRS complex.
Time frame: Up to 20 weeks
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention with post-baseline result. If participants didn't have any post-baseline measurement, the participants were not included in the denominator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 9 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 0 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 0 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 1 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 2 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QT INTERVAL, SINGLE BEAT (MSEC): Value>500 | 0 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | PR INTERVAL, SINGLE BEAT (MSEC): Value>280 | 0 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 12 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 5 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 1 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QRS DURATION, SINGLE BEAT (MSEC): Value>120 | 2 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 1 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | PR INTERVAL, SINGLE BEAT (MSEC): Value>280 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 12 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 12 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QT INTERVAL, SINGLE BEAT (MSEC): Value>500 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QRS DURATION, SINGLE BEAT (MSEC): Value>120 | 0 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | PR INTERVAL, SINGLE BEAT (MSEC): Value>280 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QRS DURATION, SINGLE BEAT (MSEC): Value>120 | 3 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QT INTERVAL, SINGLE BEAT (MSEC): Value>500 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 16 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 13 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 6 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 7 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 480<Value<500 | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | PR INTERVAL, SINGLE BEAT (MSEC): Value>280 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Value>=500 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 7 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QT INTERVAL, SINGLE BEAT (MSEC): Value>500 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QRS DURATION, SINGLE BEAT (MSEC): Value>120 | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCF INTERVAL, SINGLE BEAT (MSEC): 450<Value<=480 | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): Chg>60 | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set) | QTCB INTERVAL, SINGLE BEAT (MSEC): 30<=Chg<=60 | 6 Participants |
Secondary
Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)
The vital signs were measured included temperature (Oral, Tympanic, Axillary or Temporal), pulse rate (beats/min) and blood pressure (mmHg).
Time frame: Up to 20 weeks
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Diastolic Blood Pressure (MMHG): Change >= 20mmHg increase | 2 Participants |
| Placebo | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Systolic Blood Pressure (MMHG): Change >= 30mmHg increase | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Systolic Blood Pressure (MMHG): Change >= 30mmHg increase | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Diastolic Blood Pressure (MMHG): Change >= 20mmHg increase | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Diastolic Blood Pressure (MMHG): Change >= 20mmHg increase | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Systolic Blood Pressure (MMHG): Change >= 30mmHg increase | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Diastolic Blood Pressure (MMHG): Change >= 20mmHg increase | 4 Participants |
| PF-06826647 400mg QD | Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set) | Supine Systolic Blood Pressure (MMHG): Change >= 30mmHg increase | 4 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Time frame: Up to 20 weeks
Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with adverse events | 23 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with serious adverse events | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with severe adverse events | 1 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued from study due to adverse events | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued study drug due to AE and continued Study | 1 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with temporary discontinuation due to adverse events | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with temporary discontinuation due to adverse events | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued from study due to adverse events | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with adverse events | 26 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with severe adverse events | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with serious adverse events | 2 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued study drug due to AE and continued Study | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with serious adverse events | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with severe adverse events | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued from study due to adverse events | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with temporary discontinuation due to adverse events | 3 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued study drug due to AE and continued Study | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with adverse events | 30 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued study drug due to AE and continued Study | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with temporary discontinuation due to adverse events | 5 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with serious adverse events | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants discontinued from study due to adverse events | 6 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with adverse events | 29 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Participants with severe adverse events | 4 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
The treatment-emergent AEs (TEAEs) were considered as an adverse event that started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time was flagged as TEAEs.
Time frame: Up to 20 weeks
Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with adverse events | 7 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with serious adverse events | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with severe adverse events | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued from study due to adverse events | 0 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued study drug due to AE and continued Study | 1 Participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with temporary discontinuation due to adverse events | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with temporary discontinuation due to adverse events | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued from study due to adverse events | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with adverse events | 10 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with severe adverse events | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with serious adverse events | 1 Participants |
| PF-06650833 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued study drug due to AE and continued Study | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with serious adverse events | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with severe adverse events | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued from study due to adverse events | 1 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with temporary discontinuation due to adverse events | 0 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued study drug due to AE and continued Study | 2 Participants |
| PF-06700841 45mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with adverse events | 12 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued study drug due to AE and continued Study | 0 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with temporary discontinuation due to adverse events | 2 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with serious adverse events | 1 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants discontinued from study due to adverse events | 4 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with adverse events | 16 Participants |
| PF-06826647 400mg QD | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) | Participants with severe adverse events | 3 Participants |
Secondary
Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI).
This estimand was intended to provide difference between treated and placebo in percentage of participants with a total AN count of 0 or 1, or 0, 1 or 2, respectively at week 16. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At week 16
Population: All participants randomized and received at least one dose of study intervention. In PF-06826647 400mg QD treatment group, 1 participant discontinued the study due to COVID-19 pandemic during study Days 9 - 16. Based on the pre-specification in the statistical analysis plan (SAP), this participant was excluded from the analysis after the treatment discontinuation visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0 or 1 | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0, 1 or 2 | 22.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0, 1 or 2 | 27.7 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0 or 1 | 17.0 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0 or 1 | 28.8 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0, 1 or 2 | 38.5 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0 or 1 | 23.9 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI). | Total AN Count of 0, 1 or 2 | 32.6 Percentage of participants |
Comparison: Total AN Count of 0 or 1p-value: 0.51590% CI: [-12.7, 12.1]MR weighting strategy
Comparison: Total AN Count of 0 or 1p-value: 0.073790% CI: [-1.4, 25.8]MR weighting strategy
Comparison: Total AN Count of 0 or 1p-value: 0.208190% CI: [-6.7, 20]MR weighting strategy
Comparison: Total AN Count of 0, 1 or 2p-value: 0.295790% CI: [-9.9, 19.4]MR weighting strategy
Comparison: Total AN Count of 0, 1 or 2p-value: 0.045690% CI: [0.7, 30.5]MR weighting strategy
Comparison: Total AN Count of 0, 1 or 2p-value: 0.155890% CI: [-5.7, 24.1]MR weighting strategy
Secondary
Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)
The Dermatology Life Quality Index (DLQI) is a general dermatology questionnaire that consists of 10 items that assess patient health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) over the last week. Scoring for each item is on a qualitative 0 to 3 scale, with options of Not at all, A little, A lot, Very much. The scores are added up to a total composite score with the range from the minimum score of 0 to the maximum score of 30. The higher the score, the worse the outcomes. The assessments examined the percentage of patients with complete resolution of dermatology specific quality of life impact, as assessed by a total score of ≤ 1 (range: 0 - 30), where higher percentage indicates better improvement in DLQI.
Time frame: At weeks 4, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention with baseline \>1 score were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 4 | 6.8 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 8 | 2.2 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 12 | 4.4 Percentage of Participants |
| Placebo | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 16 | 4.4 Percentage of Participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 8 | 6.8 Percentage of Participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 12 | 13.6 Percentage of Participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 16 | 4.5 Percentage of Participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 4 | 6.8 Percentage of Participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 12 | 10.9 Percentage of Participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 8 | 8.7 Percentage of Participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 16 | 10.9 Percentage of Participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 4 | 8.9 Percentage of Participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 16 | 11.6 Percentage of Participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 8 | 4.7 Percentage of Participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 4 | 2.3 Percentage of Participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI) | Week 12 | 7.0 Percentage of Participants |
Comparison: Week 490% CI: [-9.1, 9.5]
Comparison: Week 490% CI: [-7.4, 9.8]
Comparison: Week 490% CI: [-11.4, 3.4]
Comparison: Week 890% CI: [-3.3, 11.8]
Comparison: Week 890% CI: [-1.8, 14.2]
Comparison: Week 890% CI: [-4.8, 9.8]
Comparison: Week 1290% CI: [-1.3, 16.5]
Comparison: Week 1290% CI: [-2, 15.7]
Comparison: Week 1290% CI: [-5.5, 11.3]
Comparison: Week 1690% CI: [-6.3, 6.4]
Comparison: Week 1690% CI: [-2.8, 15.7]
Comparison: Week 1690% CI: [-1.6, 16.9]
Secondary
Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI)
Erythema response was defined as achieving erythema score of 1 or 0 in all affected anatomic regions among participants who had an erythema score of 2 or more in at least 1 anatomic region at baseline. NRI for missing values which were related to withdrawal and all other events except for COVID-19. A four-point ordinal scale ranging was used: 0 (no redness), 1 (faint but discernible pink coloration), 2 (moderate red coloration), and 3 (very red or bright red coloration).
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention with baseline erythema score ≥2 scores in at least 1 region were included.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 1 | 6.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 12 | 15.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 8 | 15.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 2 | 10.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 16 | 13.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 4 | 13.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 6 | 13.0 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 12 | 23.3 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 6 | 27.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 4 | 20.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 8 | 25.6 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 16 | 16.3 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 2 | 20.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 1 | 4.7 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 6 | 23.9 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 1 | 8.7 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 2 | 17.8 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 4 | 28.3 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 8 | 28.3 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 12 | 30.4 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 16 | 28.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 4 | 18.2 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 16 | 18.6 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 12 | 18.6 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 2 | 18.2 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 1 | 13.6 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 8 | 23.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI) | Week 6 | 23.3 Percentage of participants |
Comparison: Week 290% CI: [-4.5, 19.7]
Comparison: Week 190% CI: [-10.3, 6]
Comparison: Week 190% CI: [-7.3, 11.3]
Comparison: Week 190% CI: [-3.9, 17.4]
Comparison: Week 290% CI: [-2, 23.4]
Comparison: Week 290% CI: [-4.6, 19.6]
Comparison: Week 490% CI: [-5.7, 20.5]
Comparison: Week 490% CI: [1.4, 28.7]
Comparison: Week 490% CI: [-8, 17.5]
Comparison: Week 690% CI: [0.7, 28]
Comparison: Week 690% CI: [-2.2, 24]
Comparison: Week 690% CI: [-2.6, 23.9]
Comparison: Week 8p-value: 0.116290% CI: [-3.6, 23.9]MR weighting strategy
Comparison: Week 8p-value: 0.064290% CI: [-0.8, 27]MR weighting strategy
Comparison: Week 8p-value: 0.166490% CI: [-5.7, 21.8]MR weighting strategy
Comparison: Week 12p-value: 0.188290% CI: [-6.1, 20.5]MR weighting strategy
Comparison: Week 12p-value: 0.042390% CI: [1.1, 28.8]MR weighting strategy
Comparison: Week 12p-value: 0.339690% CI: [-9.7, 16.3]MR weighting strategy
Comparison: Week 16p-value: 0.358490% CI: [-9.4, 14.8]MR weighting strategy
Comparison: Week 16p-value: 0.036790% CI: [1.5, 28.3]MR weighting strategy
Comparison: Week 16p-value: 0.248690% CI: [-7.4, 17.8]MR weighting strategy
Secondary
Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).
HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At weeks 1, 2, 4, 6, 8, and 12
Population: All participants randomized and received at least one dose of study intervention. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 1 | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 2 | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 4 | 31.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 6 | 37.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 8 | 43.8 Percentage of participants |
| Placebo | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 12 | 41.7 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 12 | 31.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 6 | 38.3 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 1 | 12.8 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 4 | 40.4 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 2 | 31.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 8 | 36.2 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 2 | 32.0 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 4 | 39.2 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 6 | 44.2 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 12 | 50.0 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 8 | 44.2 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 1 | 15.4 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 8 | 41.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 12 | 41.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 2 | 28.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 6 | 41.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 1 | 21.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI). | Week 4 | 27.7 Percentage of participants |
Comparison: Week 190% CI: [-15.6, 8]
Comparison: Week 190% CI: [-12.9, 11.1]
Comparison: Week 190% CI: [-8.5, 17.8]
Comparison: Week 290% CI: [-6.9, 22.8]
Comparison: Week 290% CI: [-7.1, 22.2]
Comparison: Week 290% CI: [-11.3, 18.3]
Comparison: Week 490% CI: [-7.1, 25.1]
Comparison: Week 490% CI: [-8, 23.5]
Comparison: Week 490% CI: [-19.4, 11.4]
Comparison: Week 690% CI: [-15.6, 17.2]
Comparison: Week 690% CI: [-9.4, 22.9]
Comparison: Week 690% CI: [-12.8, 20.2]
Comparison: Week 8p-value: 0.779890% CI: [-24.2, 8.7]MR weighting strategy
Comparison: Week 8p-value: 0.481990% CI: [-15.9, 16.8]MR weighting strategy
Comparison: Week 8p-value: 0.593390% CI: [-19.2, 14.4]MR weighting strategy
Comparison: Week 12p-value: 0.842190% CI: [-26.1, 6.2]MR weighting strategy
Comparison: Week 12p-value: 0.20990% CI: [-8.2, 24.2]MR weighting strategy
Comparison: Week 12p-value: 0.518390% CI: [-17.1, 16.2]MR weighting strategy
Secondary
Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)
The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention with baseline NRS≥3 scores. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Pain at its Worst) | 7.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Pain at its Worst) | 34.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Pain at its Worst) | 17.1 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Pain at its Worst) | 29.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Pain at its Worst) | 43.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Pain at its Worst) | 41.5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Pain at its Worst) | 34.1 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Pain at its Worst) | 29.7 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Pain at its Worst) | 21.6 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Pain at its Worst) | 18.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Pain at its Worst) | 21.6 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Pain at its Worst) | 16.2 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Pain at its Worst) | 21.6 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Pain at its Worst) | 29.7 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Pain at its Worst) | 28.6 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Pain at its Worst) | 50.0 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Pain at its Worst) | 40.5 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Pain at its Worst) | 35.7 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Pain at its Worst) | 38.1 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Pain at its Worst) | 16.7 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Pain at its Worst) | 40.5 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Pain at its Worst) | 24.4 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Pain at its Worst) | 35.0 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Pain at its Worst) | 29.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Pain at its Worst) | 35.0 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Pain at its Worst) | 31.7 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Pain at its Worst) | 19.5 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Pain at its Worst) | 27.5 Percentage of participants |
Comparison: Week 1 (Pain at its Worst)p-value: 0.055990% CI: [-0.7, 24.8]MR weighting strategy
Comparison: Week 1 (Pain at its Worst)p-value: 0.075890% CI: [-1.9, 21.4]MR weighting strategy
Comparison: Week 1 (Pain at its Worst)p-value: 0.063790% CI: [-0.6, 23.2]MR weighting strategy
Comparison: Week 2 (Pain at its Worst)p-value: 0.317990% CI: [-10.3, 18.8]MR weighting strategy
Comparison: Week 2 (Pain at its Worst)p-value: 0.107890% CI: [-3.5, 25.5]MR weighting strategy
Comparison: Week 2 (Pain at its Worst)p-value: 0.197690% CI: [-7, 22.2]MR weighting strategy
Comparison: Week 4 (Pain at its Worst)p-value: 0.973890% CI: [-34.3, -3.6]MR weighting strategy
Comparison: Week 4 (Pain at its Worst)p-value: 0.292590% CI: [-11.3, 22.9]MR weighting strategy
Comparison: Week 4 (Pain at its Worst)p-value: 0.617890% CI: [-19.8, 13.7]MR weighting strategy
Comparison: Week 6 (Pain at its Worst)p-value: 0.976990% CI: [-37.4, -4.4]MR weighting strategy
Comparison: Week 6 (Pain at its Worst)p-value: 0.652990% CI: [-21.6, 13.2]MR weighting strategy
Comparison: Week 6 (Pain at its Worst)p-value: 0.887890% CI: [-29.8, 4.3]MR weighting strategy
Comparison: Week 8 (Pain at its Worst)p-value: 0.725990% CI: [-22.9, 10.4]MR weighting strategy
Comparison: Week 8 (Pain at its Worst)p-value: 0.082690% CI: [-2.1, 31.6]MR weighting strategy
Comparison: Week 8 (Pain at its Worst)p-value: 0.788490% CI: [-24.1, 8]MR weighting strategy
Comparison: Week 12 (Pain at its Worst)p-value: 0.932690% CI: [-33.2, 1.1]MR weighting strategy
Comparison: Week 12 (Pain at its Worst)p-value: 0.68190% CI: [-22.1, 12.2]MR weighting strategy
Comparison: Week 12 (Pain at its Worst)p-value: 0.830890% CI: [-27.6, 7]MR weighting strategy
Comparison: Week 16 (Pain at its Worst)p-value: 0.806390% CI: [-24.5, 7.4]MR weighting strategy
Comparison: Week 16 (Pain at its Worst)p-value: 0.264990% CI: [-10.4, 23.4]MR weighting strategy
Comparison: Week 16 (Pain at its Worst)p-value: 0.302990% CI: [-11.7, 22.4]MR weighting strategy
Secondary
Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)
The rate comparing treatment and placebo groups at each visit was analyzed using CMH test with MR weighting strategy between each of active treatment group and placebo. Confidence interval (CI) was calculated using Blyth-Still-Casella method. NRS30 was defined as ≥30% reduction and ≥1 unit reduction from baseline in Patient's Global Assessment (PGA) Skin Pain NRS. The range of skin pain was from 0 to 10. Lower IHS4 absolute scores mean a better outcome. Baseline was defined as the average of all values recorded between Day -6 and Day 1. Weekly data were average values of daily observations over 7 days. NRI (non-responder imputation) for missing values which were related to withdrawal and all other events except for COVID-19.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention with baseline NRS≥3 scores. One participant in the PF-06826647 group with missing data due to COVID-19 was excluded from the main analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Average Pain) | 10.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Average Pain) | 41.0 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Average Pain) | 35.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Average Pain) | 17.9 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Average Pain) | 28.2 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Average Pain) | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Average Pain) | 48.7 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Average Pain) | 26.5 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Average Pain) | 32.4 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Average Pain) | 20.6 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Average Pain) | 26.5 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Average Pain) | 20.6 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Average Pain) | 20.6 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Average Pain) | 17.6 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Average Pain) | 48.8 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Average Pain) | 24.4 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Average Pain) | 36.6 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Average Pain) | 46.3 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Average Pain) | 56.1 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Average Pain) | 41.5 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Average Pain) | 39.0 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 4 (Average Pain) | 34.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 16 (Average Pain) | 32.4 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 12 (Average Pain) | 32.4 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 2 (Average Pain) | 22.9 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 1 (Average Pain) | 8.6 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 8 (Average Pain) | 29.4 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI) | Week 6 (Average Pain) | 34.3 Percentage of participants |
Comparison: Week 1 (Average Pain)p-value: 0.168790% CI: [-5.7, 21.2]MR weighting strategy
Comparison: Week 1 (Average Pain)p-value: 0.037690% CI: [0.6, 27]MR weighting strategy
Comparison: Week 1 (Average Pain)p-value: 0.588390% CI: [-12.9, 9.8]MR weighting strategy
Comparison: Week 2 (Average Pain)p-value: 0.382990% CI: [-12.2, 17.6]MR weighting strategy
Comparison: Week 2 (Average Pain)p-value: 0.031690% CI: [2.5, 33.9]MR weighting strategy
Comparison: Week 2 (Average Pain)p-value: 0.307290% CI: [-10.5, 19.7]MR weighting strategy
Comparison: Week 4 (Average Pain)p-value: 0.895290% CI: [-29.8, 3.7]MR weighting strategy
Comparison: Week 4 (Average Pain)p-value: 0.115790% CI: [-4.6, 30.8]MR weighting strategy
Comparison: Week 4 (Average Pain)p-value: 0.467290% CI: [-17.1, 18.9]MR weighting strategy
Comparison: Week 6 (Average Pain)p-value: 0.928790% CI: [-35.5, 1.6]MR weighting strategy
Comparison: Week 6 (Average Pain)p-value: 0.498490% CI: [-17.8, 17.9]MR weighting strategy
Comparison: Week 6 (Average Pain)p-value: 0.900190% CI: [-33.2, 3.9]MR weighting strategy
Comparison: Week 8 (Average Pain)p-value: 0.831990% CI: [-27.6, 7]MR weighting strategy
Comparison: Week 8 (Average Pain)p-value: 0.03490% CI: [2.3, 37]MR weighting strategy
Comparison: Week 8 (Average Pain)p-value: 0.735990% CI: [-24.4, 10.8]MR weighting strategy
Comparison: Week 12 (Average Pain)p-value: 0.929190% CI: [-33.3, 1.3]MR weighting strategy
Comparison: Week 12 (Average Pain)p-value: 0.508790% CI: [-17.4, 16.9]MR weighting strategy
Comparison: Week 12 (Average Pain)p-value: 0.809890% CI: [-27.2, 8.1]MR weighting strategy
Comparison: Week 16 (Average Pain)p-value: 0.811490% CI: [-24.8, 7.2]MR weighting strategy
Comparison: Week 16 (Average Pain)p-value: 0.153190% CI: [-6.4, 28]MR weighting strategy
Comparison: Week 16 (Average Pain)p-value: 0.378490% CI: [-14.1, 20.7]MR weighting strategy
Secondary
Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].
HS flare was defined as at least a 25% increase in AN count with a minimum increase of 2 relative to Baseline. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
Time frame: At weeks 4, 8, 12 and 16
Population: All participants randomized and received at least one dose of study intervention.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 4 | 13.3 Percentage of participants |
| Placebo | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 8 | 9.3 Percentage of participants |
| Placebo | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 12 | 17.5 Percentage of participants |
| Placebo | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 16 | 17.1 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 8 | 15.4 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 12 | 5.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 16 | 6.9 Percentage of participants |
| PF-06650833 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 4 | 11.9 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 12 | 2.4 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 8 | 2.3 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 16 | 0 Percentage of participants |
| PF-06700841 45mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 4 | 4.8 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 16 | 3.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 8 | 0 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 4 | 14.3 Percentage of participants |
| PF-06826647 400mg QD | Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)]. | Week 12 | 0 Percentage of participants |
Comparison: Week 490% CI: [-13, 10.3]
Comparison: Week 490% CI: [-18.7, 1.8]
Comparison: Week 490% CI: [-10.7, 14.1]
Comparison: Week 8p-value: 0.837290% CI: [-4.6, 17.7]MR weighting strategy
Comparison: Week 8p-value: 0.081990% CI: [-14.1, 1.3]MR weighting strategy
Comparison: Week 8p-value: 0.024290% CI: [-15.2, -0.9]MR weighting strategy
Comparison: Week 12p-value: 0.026490% CI: [-23.1, -2.3]MR weighting strategy
Comparison: Week 12p-value: 0.012790% CI: [-25.1, -3.9]MR weighting strategy
Comparison: Week 12p-value: 0.005990% CI: [-27, -6.2]MR weighting strategy
Comparison: Week 16p-value: 0.118590% CI: [-22.7, 3.5]MR weighting strategy
Comparison: Week 16p-value: 0.00490% CI: [-26.6, -5.6]MR weighting strategy
Comparison: Week 16p-value: 0.041890% CI: [-24.5, -1.1]MR weighting strategy
Secondary
Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)
In summary statistics for pharmacokinetic, concentration values below the lower limit of quantification (LLOQ) was set to zero.
Time frame: At weeks 1, 2, 4, 6, 8, 12 and 16
Population: All enrolled participants who took at least one dose of active PF-06700841, PF-06826647 or PF-06650833 and in whom at least one concentration value is reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 2H | 94.89 Nanograms per milliliter (ng/ml) | Standard Deviation 48.222 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 0H | 34.72 Nanograms per milliliter (ng/ml) | Standard Deviation 35.7 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 12 0H | 34.34 Nanograms per milliliter (ng/ml) | Standard Deviation 32.046 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 1H | 45.70 Nanograms per milliliter (ng/ml) | Standard Deviation 33.027 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 30MIN | 28.58 Nanograms per milliliter (ng/ml) | Standard Deviation 24.51 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 1 0H | 31.79 Nanograms per milliliter (ng/ml) | Standard Deviation 26.567 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 4 0H | 25.33 Nanograms per milliliter (ng/ml) | Standard Deviation 25.795 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 2 0H | 30.48 Nanograms per milliliter (ng/ml) | Standard Deviation 35.796 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 4H | 112.4 Nanograms per milliliter (ng/ml) | Standard Deviation 103.09 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 6 0H | 27.25 Nanograms per milliliter (ng/ml) | Standard Deviation 29.905 |
| Placebo | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 16 0H | 39.41 Nanograms per milliliter (ng/ml) | Standard Deviation 36.773 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 30MIN | 254.7 Nanograms per milliliter (ng/ml) | Standard Deviation 157.3 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 1 0H | 49.22 Nanograms per milliliter (ng/ml) | Standard Deviation 64.871 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 2 0H | 51.48 Nanograms per milliliter (ng/ml) | Standard Deviation 76.426 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 4 0H | 63.60 Nanograms per milliliter (ng/ml) | Standard Deviation 77.18 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 6 0H | 47.38 Nanograms per milliliter (ng/ml) | Standard Deviation 61.091 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 0H | 60.30 Nanograms per milliliter (ng/ml) | Standard Deviation 92.758 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 1H | 373.4 Nanograms per milliliter (ng/ml) | Standard Deviation 174.51 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 2H | 296.0 Nanograms per milliliter (ng/ml) | Standard Deviation 173.76 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 4H | 231.7 Nanograms per milliliter (ng/ml) | Standard Deviation 168.11 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 12 0H | 52.95 Nanograms per milliliter (ng/ml) | Standard Deviation 82.248 |
| PF-06650833 400mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 16 0H | 43.89 Nanograms per milliliter (ng/ml) | Standard Deviation 67.413 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 12 0H | 233.1 Nanograms per milliliter (ng/ml) | Standard Deviation 322.19 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 2H | 869.6 Nanograms per milliliter (ng/ml) | Standard Deviation 549.58 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 4 0H | 215.6 Nanograms per milliliter (ng/ml) | Standard Deviation 259.41 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 1 0H | 281.7 Nanograms per milliliter (ng/ml) | Standard Deviation 364.14 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 4H | 784.8 Nanograms per milliliter (ng/ml) | Standard Deviation 548.33 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 2 0H | 263.8 Nanograms per milliliter (ng/ml) | Standard Deviation 388.42 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 30MIN | 667.4 Nanograms per milliliter (ng/ml) | Standard Deviation 560.37 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 0H | 277.2 Nanograms per milliliter (ng/ml) | Standard Deviation 316.4 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 16 0H | 244.4 Nanograms per milliliter (ng/ml) | Standard Deviation 296.93 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 8 1H | 817.2 Nanograms per milliliter (ng/ml) | Standard Deviation 573.7 |
| PF-06700841 45mg QD | Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set) | WEEK 6 0H | 113.5 Nanograms per milliliter (ng/ml) | Standard Deviation 140.62 |