Moderate to Severe Ulcerative Colitis
Conditions
Brief summary
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
Interventions
DRUGInduction- PF-06480605 50 mg SC Q4W
PF-06480605
DRUGInduction- PF-06480605 150 mg SC Q4W
PF-06480605
DRUGInduction- PF-06480605 450 mg SC Q4W
PF-06480605
OTHERInduction- Placebo SC Q4W
0 mg Placebo
DRUGChronic- PF-06480605 50 mg SC Q4W
PF-06480605
DRUGChronic- PF-06480605 150 mg SC Q4W
PF-06480605
DRUGChronic- PF-06480605 450 mg SC Q4W
PF-06480605
Sponsors
Hoffmann-La Roche
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* A diagnosis of UC for \>=3 months. * Participants with moderate to severe active UC as defined by a Total Mayo Score of \>=6, and an endoscopic subscore of \>=2. * Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy). * Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.
Exclusion criteria
* Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.). * Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study * Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available. * 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results * Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection. * Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 | At Week 14 | Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. |
| Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.) | TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe. |
| Induction Period: Number of Participants With Serious Adverse Events (SAEs) | From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe. |
| Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation | From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe. |
| Chronic Period: Number of Participants With TEAEs | From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.) | TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe. |
| Chronic Period: Number of Participants With SAEs | From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe. |
| Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | Induction Period: At Week 14; Chronic Period: At Week 56 | Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. |
| Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | Induction Period: At Week 14; Chronic Period: At Week 56 | Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. |
| Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | Induction Period: At Week 14; Chrnoic Period: At Week 56 | Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number. |
| Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | Induction Period: At Week 14; Chronic Period: At Week 56 | Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number. |
| Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Induction Period: 30 mins postdose on Day 1, Weeks 4, 8, 12 and 14; Chronic Period: 30 mins postdose on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (Week 52) and Follow-up (FU) Visits 1 (Week 56), 2 (Week 60) and 3 (Week 64) | — |
| Induction Period: Change From Baseline in Fecal Calprotectin | Baseline, Weeks 4, 8, and 12 | — |
| Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline, Weeks 4, 8, and 12 | — |
| Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Baseline, Weeks 4, 8, and 12 | — |
| Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | Baseline, Weeks 4, 8, 12, 14 | Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5. |
| Chronic Period: Percentage of Participants Who Achieved Clinical Remission | At Week 56 | Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number. |
| Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | At Weeks 14 and 56 | Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. |
| Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | At Weeks 14 and 56 | Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. |
| Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | At Weeks 14 and 56 | Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. |
| Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | At Weeks 14 and 56 | Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. |
| Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | At Weeks 14 and 56 | Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number. |
| Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 (baseline), Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64 | — |
| Chronic Period: Change From Week 14 in hsCRP | Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 | — |
| Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 | — |
| Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64 | — |
| Change From Baseline in hsCRP Through the End of Study | Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 | — |
| Change From Baseline in Serum sTL1A Through the End of Study | Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64 | — |
| Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64 | Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5. |
Countries
Australia, Belgium, Bulgaria, Colombia, France, Germany, Hungary, India, Italy, Japan, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Recruitment details
A total of 246 participants with moderate to severe ulcerative colitis (UC) took part in the study at 114 investigative sites across 23 countries from 19 December 2019 to 25 October 2022. The study consisted of a 12-week induction period and a 40-week chronic therapy period.
Pre-assignment details
Participants were randomized in 2:2:2:2:2:3:1:1:1 to 1 of 9 treatment sequences to receive PF-06480605 50 milligrams (mg), 150 mg, 450 mg or a matched placebo during the induction and chronic therapy periods. One participant in the PF-06480605 450 mg arm was enrolled but did not receive any treatment.
Participants by arm
| Arm | Count |
|---|---|
| Induction Period: Placebo Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12. | 45 |
| Induction Period: PF-06480605 50 mg Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12. | 47 |
| Induction Period: PF-06480605 150 mg Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12. | 62 |
| Induction Period: PF-06480605 450 mg Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12. | 91 |
| Total | 245 |
Baseline characteristics
| Characteristic | Induction Period: Placebo | Induction Period: PF-06480605 50 mg | Induction Period: PF-06480605 150 mg | Induction Period: PF-06480605 450 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 12.9 | 37.8 years STANDARD_DEVIATION 13.91 | 42.2 years STANDARD_DEVIATION 13.02 | 41.6 years STANDARD_DEVIATION 13.79 | 40.7 years STANDARD_DEVIATION 13.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 43 Participants | 55 Participants | 86 Participants | 226 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 5 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 9 Participants | 9 Participants | 18 Participants | 49 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 30 Participants | 35 Participants | 49 Participants | 70 Participants | 184 Participants |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 23 Participants | 36 Participants | 99 Participants |
| Sex: Female, Male Male | 24 Participants | 28 Participants | 39 Participants | 55 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 47 | 0 / 62 | 0 / 91 | 0 / 12 | 0 / 14 | 0 / 14 | 0 / 46 | 0 / 27 | 0 / 30 | 0 / 26 | 0 / 26 | 0 / 29 |
| other Total, other adverse events | 16 / 45 | 11 / 47 | 20 / 62 | 34 / 91 | 5 / 12 | 9 / 14 | 9 / 14 | 24 / 46 | 15 / 27 | 12 / 30 | 14 / 26 | 15 / 26 | 14 / 29 |
| serious Total, serious adverse events | 4 / 45 | 3 / 47 | 1 / 62 | 4 / 91 | 0 / 12 | 0 / 14 | 0 / 14 | 5 / 46 | 1 / 27 | 0 / 30 | 2 / 26 | 1 / 26 | 4 / 29 |
Outcome results
Primary
Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Time frame: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Population: Evaluable population mITT included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
Primary
Chronic Period: Number of Participants With SAEs
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Time frame: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Population: Evaluable population mITT included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Number of Participants With SAEs | 0 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With SAEs | 0 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With SAEs | 0 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With SAEs | 5 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With SAEs | 1 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With SAEs | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With SAEs | 2 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With SAEs | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With SAEs | 4 Participants |
Primary
Chronic Period: Number of Participants With TEAEs
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Time frame: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Population: Evaluable population modified intent-to-treat (mITT) included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Number of Participants With TEAEs | 5 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With TEAEs | 9 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With TEAEs | 9 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With TEAEs | 30 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With TEAEs | 16 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With TEAEs | 15 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With TEAEs | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With TEAEs | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With TEAEs | 20 Participants |
Primary
Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Time frame: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Population: Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Period: Placebo | Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
| Induction Period: PF-06480605 450 mg | Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation | 0 Participants |
Primary
Induction Period: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Time frame: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Population: Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Period: Placebo | Induction Period: Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Serious Adverse Events (SAEs) | 3 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Induction Period: PF-06480605 450 mg | Induction Period: Number of Participants With Serious Adverse Events (SAEs) | 4 Participants |
Primary
Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Time frame: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Population: Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Period: Placebo | Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 25 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 16 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 29 Participants |
| Induction Period: PF-06480605 450 mg | Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 49 Participants |
Primary
Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: At Week 14
Population: Evaluable population ITT included all participants randomly assigned to IP and who took at least one dose of IP in induction period. Participants were analyzed according to the product they received. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 | 11.6 percentage of participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 | 25.5 percentage of participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 | 23.3 percentage of participants |
| Induction Period: PF-06480605 450 mg | Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14 | 23.9 percentage of participants |
p-value: 0.054590% CI: [-0.2, 27.65]Chan and Zhang Method
p-value: 0.082390% CI: [-1.7, 24.09]Chan and Zhang Method
p-value: 0.064290% CI: [-0.64, 22.91]Chan and Zhang Method
Secondary
Change From Baseline in Fecal Calprotectin Through the End of Study
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. As pre-specified in the statistical analysis plan (SAP), data is presented using the treatment sequence in the chronic period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -0.21 μg/g | Standard Deviation 1.742 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | 0.41 μg/g | Standard Deviation 2.745 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -0.36 μg/g | Standard Deviation 1.169 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | 0.46 μg/g | Standard Deviation 2.788 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 10.43 μg/g | Standard Deviation 1.53 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -0.61 μg/g | Standard Deviation 2.247 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -0.92 μg/g | Standard Deviation 2.115 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -1.76 μg/g | Standard Deviation 2.456 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -1.43 μg/g | Standard Deviation 2.92 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -1.05 μg/g | Standard Deviation 2.958 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -1.99 μg/g | Standard Deviation 2.555 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -1.05 μg/g | Standard Deviation 2.653 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -1.22 μg/g | Standard Deviation 2.64 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -1.76 μg/g | Standard Deviation 2.42 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -1.89 μg/g | Standard Deviation 2.781 |
| Induction Period: Placebo | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -1.19 μg/g | Standard Deviation 2.692 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -1.53 μg/g | Standard Deviation 2.796 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -1.87 μg/g | Standard Deviation 2.871 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -3.14 μg/g | Standard Deviation 2.233 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -2.45 μg/g | Standard Deviation 2.916 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 11.06 μg/g | Standard Deviation 1.45 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -1.73 μg/g | Standard Deviation 2.941 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -1.95 μg/g | Standard Deviation 3.001 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -1.30 μg/g | Standard Deviation 2.745 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -0.84 μg/g | Standard Deviation 2.026 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -0.56 μg/g | Standard Deviation 1.601 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -3.08 μg/g | Standard Deviation 3.021 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -1.00 μg/g | Standard Deviation 1.778 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -0.21 μg/g | Standard Deviation 0.925 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -1.68 μg/g | Standard Deviation 2.505 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -2.48 μg/g | Standard Deviation 2.935 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -2.56 μg/g | Standard Deviation 2.525 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -2.35 μg/g | Standard Deviation 3.701 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -1.21 μg/g | Standard Deviation 3.752 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -3.27 μg/g | Standard Deviation 2.568 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -3.02 μg/g | Standard Deviation 2.912 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -2.52 μg/g | Standard Deviation 3.263 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -2.87 μg/g | Standard Deviation 4.006 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -1.32 μg/g | Standard Deviation 4.008 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -0.43 μg/g | Standard Deviation 3.261 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -2.87 μg/g | Standard Deviation 2.951 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 10.44 μg/g | Standard Deviation 2.984 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -0.67 μg/g | Standard Deviation 3.908 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -2.35 μg/g | Standard Deviation 2.768 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -1.63 μg/g | Standard Deviation 3.097 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -2.70 μg/g | Standard Deviation 2.246 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -3.11 μg/g | Standard Deviation 3.401 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -1.15 μg/g | Standard Deviation 2.572 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -1.60 μg/g | Standard Deviation 3.435 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -1.80 μg/g | Standard Deviation 3.019 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -0.38 μg/g | Standard Deviation 1.973 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -1.16 μg/g | Standard Deviation 2.744 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -1.36 μg/g | Standard Deviation 2.837 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -1.20 μg/g | Standard Deviation 3.371 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 9.91 μg/g | Standard Deviation 2.069 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -1.48 μg/g | Standard Deviation 3.378 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -1.36 μg/g | Standard Deviation 3.019 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -1.71 μg/g | Standard Deviation 3.104 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -0.78 μg/g | Standard Deviation 2.906 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -1.00 μg/g | Standard Deviation 3.05 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -1.27 μg/g | Standard Deviation 2.652 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -1.31 μg/g | Standard Deviation 3.225 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -1.19 μg/g | Standard Deviation 3.384 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -1.35 μg/g | Standard Deviation 3.354 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -1.87 μg/g | Standard Deviation 2.328 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -2.20 μg/g | Standard Deviation 2.564 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -1.56 μg/g | Standard Deviation 1.722 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -2.46 μg/g | Standard Deviation 2.75 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -2.03 μg/g | Standard Deviation 2.251 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -2.30 μg/g | Standard Deviation 2.662 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 11.12 μg/g | Standard Deviation 1.472 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -2.05 μg/g | Standard Deviation 2.327 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -2.62 μg/g | Standard Deviation 2.563 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -2.59 μg/g | Standard Deviation 2.491 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -2.39 μg/g | Standard Deviation 2.68 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -2.17 μg/g | Standard Deviation 2.13 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -2.62 μg/g | Standard Deviation 2.906 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -2.31 μg/g | Standard Deviation 2.91 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -2.93 μg/g | Standard Deviation 2.999 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -2.81 μg/g | Standard Deviation 2.789 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -2.42 μg/g | Standard Deviation 3.174 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -1.69 μg/g | Standard Deviation 3.357 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -2.63 μg/g | Standard Deviation 3.885 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -2.55 μg/g | Standard Deviation 2.883 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -2.10 μg/g | Standard Deviation 2.824 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -2.29 μg/g | Standard Deviation 3.768 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -2.85 μg/g | Standard Deviation 3.782 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -2.61 μg/g | Standard Deviation 3.609 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -2.31 μg/g | Standard Deviation 3.468 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -2.24 μg/g | Standard Deviation 3.311 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -2.96 μg/g | Standard Deviation 3.311 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -2.40 μg/g | Standard Deviation 4.271 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -2.89 μg/g | Standard Deviation 3.346 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -2.50 μg/g | Standard Deviation 3.129 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 10.38 μg/g | Standard Deviation 2.683 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -1.03 μg/g | Standard Deviation 3.037 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -0.87 μg/g | Standard Deviation 3.039 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -2.29 μg/g | Standard Deviation 3.142 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -1.74 μg/g | Standard Deviation 3.257 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 10.41 μg/g | Standard Deviation 1.218 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -1.90 μg/g | Standard Deviation 3.306 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -1.46 μg/g | Standard Deviation 2.729 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -1.28 μg/g | Standard Deviation 3.038 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -1.61 μg/g | Standard Deviation 3.685 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -1.21 μg/g | Standard Deviation 3.159 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -1.09 μg/g | Standard Deviation 3.077 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -2.11 μg/g | Standard Deviation 3.406 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -1.58 μg/g | Standard Deviation 3.128 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -1.56 μg/g | Standard Deviation 3.253 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -1.60 μg/g | Standard Deviation 3.431 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -1.25 μg/g | Standard Deviation 2.899 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -1.17 μg/g | Standard Deviation 2.198 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -1.75 μg/g | Standard Deviation 3.477 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -1.73 μg/g | Standard Deviation 3.158 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -1.58 μg/g | Standard Deviation 3.213 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -2.41 μg/g | Standard Deviation 3.338 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -1.76 μg/g | Standard Deviation 3.108 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -1.52 μg/g | Standard Deviation 3.478 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -1.46 μg/g | Standard Deviation 3.8 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -1.70 μg/g | Standard Deviation 3.353 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -2.39 μg/g | Standard Deviation 3.217 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -2.20 μg/g | Standard Deviation 2.991 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -2.03 μg/g | Standard Deviation 4.805 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -1.26 μg/g | Standard Deviation 3.043 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 9.95 μg/g | Standard Deviation 2.225 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -2.08 μg/g | Standard Deviation 3.07 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -1.48 μg/g | Standard Deviation 3.014 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -0.80 μg/g | Standard Deviation 2.727 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 20 | -1.55 μg/g | Standard Deviation 2.49 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 60 | -2.07 μg/g | Standard Deviation 2.843 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 12 | -1.31 μg/g | Standard Deviation 2.634 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 44 | -2.08 μg/g | Standard Deviation 2.932 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 8 | -1.27 μg/g | Standard Deviation 2.874 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 24 | -0.95 μg/g | Standard Deviation 2.877 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 64 | -2.38 μg/g | Standard Deviation 2.247 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 32 | -1.31 μg/g | Standard Deviation 2.032 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Baseline | 10.23 μg/g | Standard Deviation 1.446 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 16 | -1.08 μg/g | Standard Deviation 2.368 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 4 | -0.69 μg/g | Standard Deviation 2.513 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 48 | -1.75 μg/g | Standard Deviation 2.562 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 36 | -2.05 μg/g | Standard Deviation 2.502 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 52 | -2.07 μg/g | Standard Deviation 2.4 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week40 | -1.87 μg/g | Standard Deviation 2.751 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Fecal Calprotectin Through the End of Study | Change From Baseline at Week 28 | -1.61 μg/g | Standard Deviation 2.428 |
Secondary
Change From Baseline in hsCRP Through the End of Study
Time frame: Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. As pre-specified in the SAP, data is presented using the treatment sequence in the chronic period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -1.27 mg/dL | Standard Deviation 1.253 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -0.85 mg/dL | Standard Deviation 1.481 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -1.03 mg/dL | Standard Deviation 2.061 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -1.19 mg/dL | Standard Deviation 1.259 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -1.18 mg/dL | Standard Deviation 2.111 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -1.02 mg/dL | Standard Deviation 1.888 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -0.92 mg/dL | Standard Deviation 3.093 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -0.97 mg/dL | Standard Deviation 1.965 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -1.01 mg/dL | Standard Deviation 2.243 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -0.58 mg/dL | Standard Deviation 2.105 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Baseline | 2.08 mg/dL | Standard Deviation 2.625 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -1.40 mg/dL | Standard Deviation 2.47 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -1.94 mg/dL | Standard Deviation 2.158 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -1.23 mg/dL | Standard Deviation 1.93 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -1.22 mg/dL | Standard Deviation 2.248 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -1.39 mg/dL | Standard Deviation 1.585 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -1.62 mg/dL | Standard Deviation 1.786 |
| Induction Period: Placebo | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -0.86 mg/dL | Standard Deviation 2.162 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -1.43 mg/dL | Standard Deviation 1.914 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | 0.08 mg/dL | Standard Deviation 2.194 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -0.22 mg/dL | Standard Deviation 1.859 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -0.19 mg/dL | Standard Deviation 2.184 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -0.60 mg/dL | Standard Deviation 2.635 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -0.52 mg/dL | Standard Deviation 2.427 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -1.03 mg/dL | Standard Deviation 2.294 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -0.96 mg/dL | Standard Deviation 2.381 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -1.03 mg/dL | Standard Deviation 1.776 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -1.21 mg/dL | Standard Deviation 1.951 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | 0.18 mg/dL | Standard Deviation 1.323 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 2.41 mg/dL | Standard Deviation 1.63 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -0.82 mg/dL | Standard Deviation 1.873 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -1.00 mg/dL | Standard Deviation 2.277 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -1.06 mg/dL | Standard Deviation 2.213 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -0.71 mg/dL | Standard Deviation 1.585 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -1.07 mg/dL | Standard Deviation 2.041 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -0.98 mg/dL | Standard Deviation 2.164 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -0.67 mg/dL | Standard Deviation 1.957 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 0.86 mg/dL | Standard Deviation 1.942 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -0.70 mg/dL | Standard Deviation 1.108 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -1.09 mg/dL | Standard Deviation 2.151 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -0.43 mg/dL | Standard Deviation 2.529 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -0.72 mg/dL | Standard Deviation 2.025 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -0.91 mg/dL | Standard Deviation 2.855 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -1.44 mg/dL | Standard Deviation 1.935 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -0.84 mg/dL | Standard Deviation 2 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -1.36 mg/dL | Standard Deviation 1.937 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -1.18 mg/dL | Standard Deviation 1.032 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -1.92 mg/dL | Standard Deviation 1.184 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -1.64 mg/dL | Standard Deviation 1.592 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -1.59 mg/dL | Standard Deviation 1.53 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -1.94 mg/dL | Standard Deviation 1.744 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -1.11 mg/dL | Standard Deviation 1.681 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -1.17 mg/dL | Standard Deviation 2.435 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -1.66 mg/dL | Standard Deviation 1.908 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 1.42 mg/dL | Standard Deviation 1.989 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -0.66 mg/dL | Standard Deviation 1.749 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -0.44 mg/dL | Standard Deviation 2.106 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -0.61 mg/dL | Standard Deviation 2.078 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -0.89 mg/dL | Standard Deviation 2.009 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -0.71 mg/dL | Standard Deviation 2.026 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -0.94 mg/dL | Standard Deviation 1.993 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -0.77 mg/dL | Standard Deviation 2.377 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -0.56 mg/dL | Standard Deviation 2.112 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -0.74 mg/dL | Standard Deviation 2.371 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -0.64 mg/dL | Standard Deviation 2.236 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -0.43 mg/dL | Standard Deviation 1.66 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -0.58 mg/dL | Standard Deviation 1.887 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -0.47 mg/dL | Standard Deviation 1.912 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -0.70 mg/dL | Standard Deviation 2.227 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -0.53 mg/dL | Standard Deviation 2.056 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -0.99 mg/dL | Standard Deviation 2.154 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -0.77 mg/dL | Standard Deviation 2.162 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -1.45 mg/dL | Standard Deviation 1.768 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -0.80 mg/dL | Standard Deviation 1.811 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -1.03 mg/dL | Standard Deviation 2.015 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -1.29 mg/dL | Standard Deviation 1.756 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -0.85 mg/dL | Standard Deviation 2.109 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -1.05 mg/dL | Standard Deviation 2.045 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -0.61 mg/dL | Standard Deviation 1.931 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -0.85 mg/dL | Standard Deviation 1.585 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -1.37 mg/dL | Standard Deviation 2.262 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -0.73 mg/dL | Standard Deviation 2.143 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -0.34 mg/dL | Standard Deviation 2.332 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -1.07 mg/dL | Standard Deviation 1.671 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -0.83 mg/dL | Standard Deviation 2.158 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -1.12 mg/dL | Standard Deviation 2.293 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -1.05 mg/dL | Standard Deviation 1.95 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 1.35 mg/dL | Standard Deviation 1.638 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -0.79 mg/dL | Standard Deviation 2.136 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -1.47 mg/dL | Standard Deviation 1.876 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -0.82 mg/dL | Standard Deviation 2.135 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 1.22 mg/dL | Standard Deviation 1.865 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -1.10 mg/dL | Standard Deviation 2.086 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -1.06 mg/dL | Standard Deviation 2.098 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -0.76 mg/dL | Standard Deviation 1.867 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -0.52 mg/dL | Standard Deviation 2.399 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -0.57 mg/dL | Standard Deviation 2.027 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -1.14 mg/dL | Standard Deviation 2.198 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -0.95 mg/dL | Standard Deviation 1.9 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -0.84 mg/dL | Standard Deviation 2.009 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -1.18 mg/dL | Standard Deviation 1.814 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -0.37 mg/dL | Standard Deviation 2.008 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -0.73 mg/dL | Standard Deviation 1.967 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -0.78 mg/dL | Standard Deviation 2.213 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -1.22 mg/dL | Standard Deviation 1.981 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -1.13 mg/dL | Standard Deviation 1.951 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -0.97 mg/dL | Standard Deviation 1.911 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -0.71 mg/dL | Standard Deviation 2.434 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -1.10 mg/dL | Standard Deviation 1.645 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -0.98 mg/dL | Standard Deviation 2.03 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -1.03 mg/dL | Standard Deviation 1.963 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 1.23 mg/dL | Standard Deviation 1.687 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -0.74 mg/dL | Standard Deviation 1.75 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -0.05 mg/dL | Standard Deviation 1.966 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -0.52 mg/dL | Standard Deviation 1.73 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -0.44 mg/dL | Standard Deviation 1.778 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -0.71 mg/dL | Standard Deviation 1.841 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -0.87 mg/dL | Standard Deviation 2.125 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -0.98 mg/dL | Standard Deviation 1.957 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -0.84 mg/dL | Standard Deviation 1.802 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -1.21 mg/dL | Standard Deviation 2.006 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -0.97 mg/dL | Standard Deviation 1.98 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -1.35 mg/dL | Standard Deviation 1.743 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -1.06 mg/dL | Standard Deviation 1.992 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -0.88 mg/dL | Standard Deviation 2.06 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -0.93 mg/dL | Standard Deviation 2.133 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -1.50 mg/dL | Standard Deviation 1.432 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -1.40 mg/dL | Standard Deviation 1.382 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -1.15 mg/dL | Standard Deviation 1.853 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -1.03 mg/dL | Standard Deviation 1.411 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -1.71 mg/dL | Standard Deviation 1.67 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -1.48 mg/dL | Standard Deviation 1.391 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -1.60 mg/dL | Standard Deviation 1.558 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -1.07 mg/dL | Standard Deviation 1.87 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -1.12 mg/dL | Standard Deviation 1.478 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 1.91 mg/dL | Standard Deviation 1.948 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -1.48 mg/dL | Standard Deviation 1.517 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -1.22 mg/dL | Standard Deviation 1.456 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -1.35 mg/dL | Standard Deviation 1.72 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -0.61 mg/dL | Standard Deviation 2.365 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -1.07 mg/dL | Standard Deviation 1.441 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -1.50 mg/dL | Standard Deviation 1.646 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -0.82 mg/dL | Standard Deviation 1.648 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -1.19 mg/dL | Standard Deviation 1.39 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 16 | -1.09 mg/dL | Standard Deviation 1.783 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 20 | -1.16 mg/dL | Standard Deviation 1.718 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 24 | -1.14 mg/dL | Standard Deviation 1.639 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 60 | -1.91 mg/dL | Standard Deviation 2.213 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 28 | -1.18 mg/dL | Standard Deviation 1.844 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 8 | -1.02 mg/dL | Standard Deviation 1.695 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 32 | -1.31 mg/dL | Standard Deviation 1.988 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 36 | -1.18 mg/dL | Standard Deviation 1.915 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 64 | -1.69 mg/dL | Standard Deviation 2.336 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week40 | -1.60 mg/dL | Standard Deviation 1.802 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 4 | -0.97 mg/dL | Standard Deviation 1.656 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 44 | -1.69 mg/dL | Standard Deviation 1.423 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 48 | -1.47 mg/dL | Standard Deviation 1.67 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 52 | -1.54 mg/dL | Standard Deviation 1.863 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Baseline | 2.53 mg/dL | Standard Deviation 1.803 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 56 | -1.32 mg/dL | Standard Deviation 2.07 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 14 | -0.98 mg/dL | Standard Deviation 1.603 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in hsCRP Through the End of Study | Change From Baseline at Week 12 | -0.95 mg/dL | Standard Deviation 1.646 |
Secondary
Change From Baseline in Serum sTL1A Through the End of Study
Time frame: Baseline, Weeks 4, 8, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. As pre-specified in the SAP, data is presented using the treatment sequence in the chronic period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 4.05 pg/mL | Standard Deviation 0.978 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 3.31 pg/mL | Standard Deviation 1.611 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | -0.05 pg/mL | Standard Deviation 0.708 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 3.08 pg/mL | Standard Deviation 1.718 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 3.83 pg/mL | Standard Deviation 1.308 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | 0.09 pg/mL | Standard Deviation 0.458 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 3.70 pg/mL | Standard Deviation 1.262 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 3.47 pg/mL | Standard Deviation 1.156 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 3.53 pg/mL | Standard Deviation 1.172 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | -0.10 pg/mL | Standard Deviation 0.908 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.76 pg/mL | Standard Deviation 0.524 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 3.56 pg/mL | Standard Deviation 1.13 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 3.47 pg/mL | Standard Deviation 1.247 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 3.29 pg/mL | Standard Deviation 1.5 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | 0.14 pg/mL | Standard Deviation 0.383 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 3.04 pg/mL | Standard Deviation 1.182 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 2.94 pg/mL | Standard Deviation 1.14 |
| Induction Period: Placebo | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 0.08 pg/mL | Standard Deviation 0.474 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 4.17 pg/mL | Standard Deviation 1.415 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 0.28 pg/mL | Standard Deviation 1.209 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | 0.02 pg/mL | Standard Deviation 0.329 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | 0.56 pg/mL | Standard Deviation 1.384 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | -0.01 pg/mL | Standard Deviation 0.329 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 3.51 pg/mL | Standard Deviation 1.742 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 3.65 pg/mL | Standard Deviation 1.865 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 3.31 pg/mL | Standard Deviation 1.961 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 3.48 pg/mL | Standard Deviation 1.919 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 3.90 pg/mL | Standard Deviation 1.564 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | -0.01 pg/mL | Standard Deviation 0.349 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.93 pg/mL | Standard Deviation 0.3 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 3.43 pg/mL | Standard Deviation 1.928 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 4.06 pg/mL | Standard Deviation 1.536 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 3.42 pg/mL | Standard Deviation 1.682 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 3.99 pg/mL | Standard Deviation 1.497 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 3.67 pg/mL | Standard Deviation 1.671 |
| Induction Period: PF-06480605 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 3.75 pg/mL | Standard Deviation 1.543 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | -0.10 pg/mL | Standard Deviation 0.267 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.89 pg/mL | Standard Deviation 0.499 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | -0.02 pg/mL | Standard Deviation 0.221 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | -0.17 pg/mL | Standard Deviation 0.365 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | -0.23 pg/mL | Standard Deviation 0.329 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | -0.11 pg/mL | Standard Deviation 0.305 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 5.19 pg/mL | Standard Deviation 0.861 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 5.41 pg/mL | Standard Deviation 0.771 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 5.67 pg/mL | Standard Deviation 0.742 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 5.62 pg/mL | Standard Deviation 0.62 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 5.55 pg/mL | Standard Deviation 0.842 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 5.44 pg/mL | Standard Deviation 0.951 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 5.34 pg/mL | Standard Deviation 1.093 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 5.46 pg/mL | Standard Deviation 1.019 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 5.43 pg/mL | Standard Deviation 1.211 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 5.35 pg/mL | Standard Deviation 1.132 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 5.07 pg/mL | Standard Deviation 1.553 |
| Induction Period: PF-06480605 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 4.50 pg/mL | Standard Deviation 1.9 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.73 pg/mL | Standard Deviation 0.503 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | 2.93 pg/mL | Standard Deviation 1.629 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 3.01 pg/mL | Standard Deviation 1.71 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 2.87 pg/mL | Standard Deviation 1.992 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 2.96 pg/mL | Standard Deviation 1.813 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 2.97 pg/mL | Standard Deviation 1.598 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 2.94 pg/mL | Standard Deviation 1.668 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 2.99 pg/mL | Standard Deviation 1.684 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | 2.99 pg/mL | Standard Deviation 1.697 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 3.04 pg/mL | Standard Deviation 1.839 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 2.98 pg/mL | Standard Deviation 1.71 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | 3.50 pg/mL | Standard Deviation 1.051 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 2.82 pg/mL | Standard Deviation 1.903 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | 3.18 pg/mL | Standard Deviation 1.331 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 3.08 pg/mL | Standard Deviation 1.445 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 2.86 pg/mL | Standard Deviation 1.881 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 2.98 pg/mL | Standard Deviation 1.762 |
| Induction Period: PF-06480605 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 2.64 pg/mL | Standard Deviation 2.059 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | 3.84 pg/mL | Standard Deviation 1.613 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 3.57 pg/mL | Standard Deviation 1.608 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 3.25 pg/mL | Standard Deviation 1.637 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 3.16 pg/mL | Standard Deviation 1.573 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | 3.98 pg/mL | Standard Deviation 1.561 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 3.95 pg/mL | Standard Deviation 1.664 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | 3.55 pg/mL | Standard Deviation 1.849 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | 3.73 pg/mL | Standard Deviation 1.445 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 3.02 pg/mL | Standard Deviation 1.644 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 3.20 pg/mL | Standard Deviation 1.715 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 3.31 pg/mL | Standard Deviation 1.714 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 3.01 pg/mL | Standard Deviation 1.695 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 3.46 pg/mL | Standard Deviation 1.678 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 3.00 pg/mL | Standard Deviation 1.719 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 3.30 pg/mL | Standard Deviation 1.657 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.77 pg/mL | Standard Deviation 0.52 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 3.09 pg/mL | Standard Deviation 1.76 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 2.97 pg/mL | Standard Deviation 1.769 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 3.70 pg/mL | Standard Deviation 1.401 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.69 pg/mL | Standard Deviation 0.52 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 3.97 pg/mL | Standard Deviation 1.419 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | 3.96 pg/mL | Standard Deviation 1.406 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 3.61 pg/mL | Standard Deviation 2.155 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 3.96 pg/mL | Standard Deviation 1.338 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 3.92 pg/mL | Standard Deviation 1.535 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | 3.76 pg/mL | Standard Deviation 1.443 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 3.99 pg/mL | Standard Deviation 1.46 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 4.07 pg/mL | Standard Deviation 1.582 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | 3.75 pg/mL | Standard Deviation 1.471 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 3.89 pg/mL | Standard Deviation 1.421 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | 3.97 pg/mL | Standard Deviation 1.218 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 4.25 pg/mL | Standard Deviation 1.438 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 3.75 pg/mL | Standard Deviation 1.383 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 4.26 pg/mL | Standard Deviation 1.325 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 3.60 pg/mL | Standard Deviation 2.046 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 4.24 pg/mL | Standard Deviation 1.51 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | 4.88 pg/mL | Standard Deviation 0.987 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | 4.40 pg/mL | Standard Deviation 2.472 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 3.74 pg/mL | Standard Deviation 2.346 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.83 pg/mL | Standard Deviation 0.706 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 4.37 pg/mL | Standard Deviation 2.724 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 3.10 pg/mL | Standard Deviation 1.605 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 3.10 pg/mL | Standard Deviation 1.725 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 2.85 pg/mL | Standard Deviation 2.115 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 2.90 pg/mL | Standard Deviation 1.893 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 3.55 pg/mL | Standard Deviation 2.22 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 4.12 pg/mL | Standard Deviation 2.459 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 3.28 pg/mL | Standard Deviation 1.789 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 3.12 pg/mL | Standard Deviation 1.854 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | 4.87 pg/mL | Standard Deviation 1.691 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 3.23 pg/mL | Standard Deviation 2.089 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 2.95 pg/mL | Standard Deviation 1.914 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 3.26 pg/mL | Standard Deviation 1.672 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | 4.34 pg/mL | Standard Deviation 2.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | 4.42 pg/mL | Standard Deviation 2.181 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | 5.29 pg/mL | Standard Deviation 0.829 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 3.67 pg/mL | Standard Deviation 2.044 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 4.05 pg/mL | Standard Deviation 1.823 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 3.72 pg/mL | Standard Deviation 1.928 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | 4.98 pg/mL | Standard Deviation 1.434 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 3.68 pg/mL | Standard Deviation 2.141 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 3.69 pg/mL | Standard Deviation 2.218 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 4.11 pg/mL | Standard Deviation 1.802 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.65 pg/mL | Standard Deviation 0.467 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 3.69 pg/mL | Standard Deviation 2.117 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 4.00 pg/mL | Standard Deviation 2.021 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 4.68 pg/mL | Standard Deviation 1.872 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 3.92 pg/mL | Standard Deviation 2.248 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 3.83 pg/mL | Standard Deviation 2.02 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | 4.59 pg/mL | Standard Deviation 1.84 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 4.49 pg/mL | Standard Deviation 1.553 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 3.84 pg/mL | Standard Deviation 2.007 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 16 | 4.66 pg/mL | Standard Deviation 1.069 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 20 | 4.40 pg/mL | Standard Deviation 1.365 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 24 | 4.33 pg/mL | Standard Deviation 1.483 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 60 | 4.42 pg/mL | Standard Deviation 1.254 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 28 | 4.42 pg/mL | Standard Deviation 1.548 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 8 | 4.74 pg/mL | Standard Deviation 0.891 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 32 | 4.39 pg/mL | Standard Deviation 1.452 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 36 | 4.58 pg/mL | Standard Deviation 1.209 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 64 | 4.39 pg/mL | Standard Deviation 1.118 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 40 | 4.42 pg/mL | Standard Deviation 1.45 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 4 | 4.65 pg/mL | Standard Deviation 0.686 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 44 | 4.57 pg/mL | Standard Deviation 1.276 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 48 | 4.61 pg/mL | Standard Deviation 1.428 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 52 | 4.53 pg/mL | Standard Deviation 1.565 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Baseline | 6.83 pg/mL | Standard Deviation 0.428 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 56 | 4.74 pg/mL | Standard Deviation 1.405 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 14 | 5.00 pg/mL | Standard Deviation 0.902 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Change From Baseline in Serum sTL1A Through the End of Study | Change From Baseline at Week 12 | 5.03 pg/mL | Standard Deviation 1.221 |
Secondary
Chronic Period: Change From Week 14 in hsCRP
Time frame: Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | -0.76 mg/dL | Standard Deviation 1.232 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | -0.50 mg/dL | Standard Deviation 1.893 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | -0.28 mg/dL | Standard Deviation 1.346 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | -0.59 mg/dL | Standard Deviation 1.596 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | -0.41 mg/dL | Standard Deviation 1.42 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | 0.35 mg/dL | Standard Deviation 1.75 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | -0.01 mg/dL | Standard Deviation 2.228 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | -1.01 mg/dL | Standard Deviation 1.398 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | -0.32 mg/dL | Standard Deviation 1.893 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | -0.17 mg/dL | Standard Deviation 0.745 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | -1.04 mg/dL | Standard Deviation 2.335 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | -0.11 mg/dL | Standard Deviation 1.709 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 1.22 mg/dL | Standard Deviation 1.667 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | -0.50 mg/dL | Standard Deviation 2.114 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | -0.32 mg/dL | Standard Deviation 1.057 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | -0.79 mg/dL | Standard Deviation 1.535 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | -0.97 mg/dL | Standard Deviation 2.09 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | -0.93 mg/dL | Standard Deviation 1.857 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | -1.29 mg/dL | Standard Deviation 1.786 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | -0.92 mg/dL | Standard Deviation 1.776 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | -1.06 mg/dL | Standard Deviation 1.37 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 2.49 mg/dL | Standard Deviation 2.149 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | -1.05 mg/dL | Standard Deviation 1.726 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | -1.29 mg/dL | Standard Deviation 1.7 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | -1.52 mg/dL | Standard Deviation 1.44 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | -1.31 mg/dL | Standard Deviation 1.707 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | -1.09 mg/dL | Standard Deviation 1.827 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | -1.12 mg/dL | Standard Deviation 1.917 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | -0.36 mg/dL | Standard Deviation 1.665 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | -1.01 mg/dL | Standard Deviation 2.445 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 0.43 mg/dL | Standard Deviation 2.484 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | -1.28 mg/dL | Standard Deviation 2.448 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | -1.12 mg/dL | Standard Deviation 2.366 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | -0.05 mg/dL | Standard Deviation 1.622 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | -1.56 mg/dL | Standard Deviation 2.351 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | -0.85 mg/dL | Standard Deviation 2.253 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | -0.63 mg/dL | Standard Deviation 2.397 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | -0.48 mg/dL | Standard Deviation 2.403 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | -1.23 mg/dL | Standard Deviation 2.619 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | -0.67 mg/dL | Standard Deviation 2.76 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | -1.59 mg/dL | Standard Deviation 2.195 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | -0.57 mg/dL | Standard Deviation 1.766 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 0.72 mg/dL | Standard Deviation 2.322 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | 0.12 mg/dL | Standard Deviation 0.895 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | 0.34 mg/dL | Standard Deviation 1.39 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | 0.28 mg/dL | Standard Deviation 1.328 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | 0.31 mg/dL | Standard Deviation 1.362 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | 0.30 mg/dL | Standard Deviation 1.72 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | 0.07 mg/dL | Standard Deviation 1.43 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | 0.17 mg/dL | Standard Deviation 1.596 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | -0.06 mg/dL | Standard Deviation 1.589 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | 0.28 mg/dL | Standard Deviation 1.749 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | 0.10 mg/dL | Standard Deviation 1.248 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | 0.25 mg/dL | Standard Deviation 1.525 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | 0.40 mg/dL | Standard Deviation 1.804 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | 0.28 mg/dL | Standard Deviation 1.633 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | 0.33 mg/dL | Standard Deviation 1.848 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | 0.31 mg/dL | Standard Deviation 1.314 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | 0.32 mg/dL | Standard Deviation 1.449 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | 0.32 mg/dL | Standard Deviation 1.565 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | 0.29 mg/dL | Standard Deviation 1.156 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | 1.21 mg/dL | Standard Deviation 1.844 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 0.26 mg/dL | Standard Deviation 1.898 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | 0.16 mg/dL | Standard Deviation 1.432 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | 0.29 mg/dL | Standard Deviation 1.49 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | 0.28 mg/dL | Standard Deviation 1.218 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | 0.23 mg/dL | Standard Deviation 1.063 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | 0.17 mg/dL | Standard Deviation 1.998 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | -0.15 mg/dL | Standard Deviation 1.612 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | 0.09 mg/dL | Standard Deviation 1.299 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | 0.04 mg/dL | Standard Deviation 1.074 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | 0.21 mg/dL | Standard Deviation 1.129 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | 0.21 mg/dL | Standard Deviation 1.213 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | 0.72 mg/dL | Standard Deviation 1.347 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | 0.26 mg/dL | Standard Deviation 1.05 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | 0.48 mg/dL | Standard Deviation 1.736 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | 0.06 mg/dL | Standard Deviation 0.882 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | -0.13 mg/dL | Standard Deviation 0.985 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | 0.51 mg/dL | Standard Deviation 0.992 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 0.11 mg/dL | Standard Deviation 1.724 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | 0.22 mg/dL | Standard Deviation 1.699 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | 0.66 mg/dL | Standard Deviation 1.083 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | 0.31 mg/dL | Standard Deviation 1.206 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | 0.28 mg/dL | Standard Deviation 1.179 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | -0.20 mg/dL | Standard Deviation 1.391 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | -0.43 mg/dL | Standard Deviation 1.507 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | -0.35 mg/dL | Standard Deviation 1.645 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | 0.05 mg/dL | Standard Deviation 1.513 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | -0.22 mg/dL | Standard Deviation 1.141 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | 0.07 mg/dL | Standard Deviation 0.985 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | 0.43 mg/dL | Standard Deviation 1.144 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | -0.18 mg/dL | Standard Deviation 1.247 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | 0.52 mg/dL | Standard Deviation 1.659 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | 0.65 mg/dL | Standard Deviation 0.994 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | 0.14 mg/dL | Standard Deviation 1.395 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 0.49 mg/dL | Standard Deviation 2.152 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | -0.56 mg/dL | Standard Deviation 1.572 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | -0.28 mg/dL | Standard Deviation 1.546 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | -0.02 mg/dL | Standard Deviation 1.76 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | -0.21 mg/dL | Standard Deviation 1.39 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | 0.20 mg/dL | Standard Deviation 1.457 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | 0.36 mg/dL | Standard Deviation 2.013 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | -0.25 mg/dL | Standard Deviation 1.347 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | 0.31 mg/dL | Standard Deviation 1.801 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | 0.19 mg/dL | Standard Deviation 1.252 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 0.56 mg/dL | Standard Deviation 1.843 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | -0.06 mg/dL | Standard Deviation 2.231 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | -0.13 mg/dL | Standard Deviation 1.372 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | 0.28 mg/dL | Standard Deviation 1.474 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | -0.55 mg/dL | Standard Deviation 1.39 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | 0.07 mg/dL | Standard Deviation 1.674 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | 0.68 mg/dL | Standard Deviation 2.359 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 52 | -0.63 mg/dL | Standard Deviation 1.221 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 24 | -0.16 mg/dL | Standard Deviation 1.387 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 36 | -0.24 mg/dL | Standard Deviation 1.614 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 20 | -0.19 mg/dL | Standard Deviation 1.362 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 44 | -0.75 mg/dL | Standard Deviation 1.272 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 64 | -0.64 mg/dL | Standard Deviation 1.802 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 40 | -0.66 mg/dL | Standard Deviation 1.154 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 60 | -0.91 mg/dL | Standard Deviation 1.643 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 28 | -0.23 mg/dL | Standard Deviation 1.044 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 56 | -0.34 mg/dL | Standard Deviation 1.463 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 48 | -0.53 mg/dL | Standard Deviation 1.254 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Week 14 | 1.55 mg/dL | Standard Deviation 1.376 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 32 | -0.29 mg/dL | Standard Deviation 1.347 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in hsCRP | Change From Week 14 at Week 16 | -0.12 mg/dL | Standard Deviation 1.283 |
Secondary
Chronic Period: Change From Week 14 in Serum sTL1A
Time frame: Week 14 (baseline), Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chornic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | 2.85 pg/mL | Standard Deviation 1.141 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | 3.45 pg/mL | Standard Deviation 0.99 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | 3.72 pg/mL | Standard Deviation 1.114 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | 3.36 pg/mL | Standard Deviation 1.108 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | 3.97 pg/mL | Standard Deviation 0.722 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | 3.15 pg/mL | Standard Deviation 1.775 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | 3.59 pg/mL | Standard Deviation 1.128 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | 2.96 pg/mL | Standard Deviation 1.033 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | 3.18 pg/mL | Standard Deviation 1.346 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | -0.13 pg/mL | Standard Deviation 0.576 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | 3.35 pg/mL | Standard Deviation 1.185 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | 3.41 pg/mL | Standard Deviation 1.068 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 6.84 pg/mL | Standard Deviation 0.443 |
| Induction Period: Placebo | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | 2.95 pg/mL | Standard Deviation 1.646 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | 0.29 pg/mL | Standard Deviation 0.328 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | 3.65 pg/mL | Standard Deviation 1.749 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | 2.88 pg/mL | Standard Deviation 1.73 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | 2.87 pg/mL | Standard Deviation 1.505 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | 3.53 pg/mL | Standard Deviation 1.811 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | 2.71 pg/mL | Standard Deviation 1.999 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | 3.43 pg/mL | Standard Deviation 1.84 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 7.21 pg/mL | Standard Deviation 1.254 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | 2.83 pg/mL | Standard Deviation 1.875 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | 2.83 pg/mL | Standard Deviation 1.601 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | 3.84 pg/mL | Standard Deviation 1.872 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | 3.09 pg/mL | Standard Deviation 1.64 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | 3.17 pg/mL | Standard Deviation 1.909 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | 3.78 pg/mL | Standard Deviation 1.759 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | 5.88 pg/mL | Standard Deviation 0.731 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | 5.65 pg/mL | Standard Deviation 0.909 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 6.67 pg/mL | Standard Deviation 0.463 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | 5.58 pg/mL | Standard Deviation 1.106 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | 4.83 pg/mL | Standard Deviation 1.86 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | 0.12 pg/mL | Standard Deviation 0.33 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | 5.66 pg/mL | Standard Deviation 0.926 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | 5.87 pg/mL | Standard Deviation 0.588 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | 5.37 pg/mL | Standard Deviation 1.556 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | 5.42 pg/mL | Standard Deviation 0.954 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | 5.73 pg/mL | Standard Deviation 1.029 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | 5.77 pg/mL | Standard Deviation 0.745 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | 5.74 pg/mL | Standard Deviation 1.224 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | 5.69 pg/mL | Standard Deviation 1.173 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | -0.02 pg/mL | Standard Deviation 0.999 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 9.78 pg/mL | Standard Deviation 1.421 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | -0.03 pg/mL | Standard Deviation 0.431 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | -0.03 pg/mL | Standard Deviation 0.675 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | -0.16 pg/mL | Standard Deviation 1.032 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | -0.10 pg/mL | Standard Deviation 1.158 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | 0.06 pg/mL | Standard Deviation 1.285 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | 0.04 pg/mL | Standard Deviation 1.243 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | -0.01 pg/mL | Standard Deviation 1.289 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | 0.03 pg/mL | Standard Deviation 1.138 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | 0.06 pg/mL | Standard Deviation 1.119 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | 0.31 pg/mL | Standard Deviation 1.155 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | -0.08 pg/mL | Standard Deviation 1.557 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | -0.28 pg/mL | Standard Deviation 1.391 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | -0.68 pg/mL | Standard Deviation 1.2 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | -0.79 pg/mL | Standard Deviation 1.198 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | -0.36 pg/mL | Standard Deviation 0.645 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | -0.73 pg/mL | Standard Deviation 1.092 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | -0.69 pg/mL | Standard Deviation 1.036 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | -0.60 pg/mL | Standard Deviation 1.303 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 10.71 pg/mL | Standard Deviation 1.543 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | -0.95 pg/mL | Standard Deviation 1.188 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | -0.80 pg/mL | Standard Deviation 1.036 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | -0.16 pg/mL | Standard Deviation 0.302 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | -0.59 pg/mL | Standard Deviation 0.912 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | -0.57 pg/mL | Standard Deviation 1.191 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | -0.83 pg/mL | Standard Deviation 1.282 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | -0.65 pg/mL | Standard Deviation 1.09 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | 0.03 pg/mL | Standard Deviation 0.494 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | 0.26 pg/mL | Standard Deviation 0.976 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | 0.14 pg/mL | Standard Deviation 0.779 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | -0.07 pg/mL | Standard Deviation 0.857 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | -0.33 pg/mL | Standard Deviation 1.531 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | -0.01 pg/mL | Standard Deviation 0.762 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | -0.41 pg/mL | Standard Deviation 1.518 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | 0.26 pg/mL | Standard Deviation 0.675 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | -0.13 pg/mL | Standard Deviation 0.924 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 10.61 pg/mL | Standard Deviation 1.488 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | -0.19 pg/mL | Standard Deviation 0.823 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | -0.11 pg/mL | Standard Deviation 0.634 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | -0.01 pg/mL | Standard Deviation 0.919 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | 0.01 pg/mL | Standard Deviation 0.743 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | -0.60 pg/mL | Standard Deviation 1.133 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | -1.28 pg/mL | Standard Deviation 1.63 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | -1.32 pg/mL | Standard Deviation 1.739 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | -1.35 pg/mL | Standard Deviation 1.812 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | -0.22 pg/mL | Standard Deviation 1.086 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | -1.25 pg/mL | Standard Deviation 1.554 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | -1.49 pg/mL | Standard Deviation 1.711 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | 0.00 pg/mL | Standard Deviation 0.987 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | -1.45 pg/mL | Standard Deviation 2.361 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | -1.36 pg/mL | Standard Deviation 1.87 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | -1.55 pg/mL | Standard Deviation 1.985 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 11.30 pg/mL | Standard Deviation 2.495 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | -1.08 pg/mL | Standard Deviation 1.337 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | -0.78 pg/mL | Standard Deviation 1.384 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | -0.54 pg/mL | Standard Deviation 1.031 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | -0.26 pg/mL | Standard Deviation 0.51 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | -0.60 pg/mL | Standard Deviation 0.958 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | -0.81 pg/mL | Standard Deviation 0.992 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | -0.87 pg/mL | Standard Deviation 1.017 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | -0.29 pg/mL | Standard Deviation 0.99 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | -0.75 pg/mL | Standard Deviation 1.017 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 11.34 pg/mL | Standard Deviation 1.752 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | -0.97 pg/mL | Standard Deviation 1.697 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | -0.90 pg/mL | Standard Deviation 0.831 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | -0.93 pg/mL | Standard Deviation 0.935 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | -0.70 pg/mL | Standard Deviation 1.583 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | -0.54 pg/mL | Standard Deviation 1.145 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | -0.74 pg/mL | Standard Deviation 0.638 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 52 | -0.55 pg/mL | Standard Deviation 1.134 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 24 | -0.70 pg/mL | Standard Deviation 1.047 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 36 | -0.60 pg/mL | Standard Deviation 0.812 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 20 | -0.61 pg/mL | Standard Deviation 0.78 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 44 | -0.59 pg/mL | Standard Deviation 0.873 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 64 | -0.75 pg/mL | Standard Deviation 1.062 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 40 | -0.67 pg/mL | Standard Deviation 0.891 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 60 | -0.64 pg/mL | Standard Deviation 0.929 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 28 | -0.65 pg/mL | Standard Deviation 1.047 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 56 | -0.33 pg/mL | Standard Deviation 0.919 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 48 | -0.47 pg/mL | Standard Deviation 0.853 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Week 14 | 11.83 pg/mL | Standard Deviation 0.726 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 32 | -0.67 pg/mL | Standard Deviation 0.914 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 14 in Serum sTL1A | Change From Week 14 at Week 16 | -0.35 pg/mL | Standard Deviation 0.435 |
Secondary
Chronic Period: Change From Week 16 in Fecal Calprotectin
Time frame: Week 16 (baseline), Weeks 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, and 64
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -1.39 μg/g | Standard Deviation 1.922 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -0.68 μg/g | Standard Deviation 2.353 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | -1.31 μg/g | Standard Deviation 2.119 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | -0.85 μg/g | Standard Deviation 1.843 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | -0.91 μg/g | Standard Deviation 2.497 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 10.22 μg/g | Standard Deviation 1.414 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | -0.68 μg/g | Standard Deviation 2.015 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -1.55 μg/g | Standard Deviation 1.984 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | -0.54 μg/g | Standard Deviation 2.208 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | -0.40 μg/g | Standard Deviation 1.174 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | -1.62 μg/g | Standard Deviation 1.814 |
| Induction Period: Placebo | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | -0.71 μg/g | Standard Deviation 1.302 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -0.39 μg/g | Standard Deviation 3.222 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 9.28 μg/g | Standard Deviation 2.578 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | -1.01 μg/g | Standard Deviation 3.642 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -1.17 μg/g | Standard Deviation 3.018 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | -0.09 μg/g | Standard Deviation 1.78 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | -1.36 μg/g | Standard Deviation 3.553 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -1.83 μg/g | Standard Deviation 2.542 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | -0.84 μg/g | Standard Deviation 1.718 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | 0.22 μg/g | Standard Deviation 3.962 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | -1.48 μg/g | Standard Deviation 2.426 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | -1.46 μg/g | Standard Deviation 2.251 |
| Induction Period: PF-06480605 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | -1.48 μg/g | Standard Deviation 2.693 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -2.84 μg/g | Standard Deviation 2.668 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -2.36 μg/g | Standard Deviation 4.202 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | -0.86 μg/g | Standard Deviation 2.562 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | -1.47 μg/g | Standard Deviation 3.331 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | -2.56 μg/g | Standard Deviation 3.178 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | -2.59 μg/g | Standard Deviation 2.493 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | -1.81 μg/g | Standard Deviation 2.705 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | -1.32 μg/g | Standard Deviation 1.956 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -1.48 μg/g | Standard Deviation 1.817 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | -2.47 μg/g | Standard Deviation 3.044 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | -1.96 μg/g | Standard Deviation 3.041 |
| Induction Period: PF-06480605 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 9.77 μg/g | Standard Deviation 2.347 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | 0.58 μg/g | Standard Deviation 2.705 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | 0.36 μg/g | Standard Deviation 3.169 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 8.86 μg/g | Standard Deviation 2.728 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | 0.17 μg/g | Standard Deviation 2.604 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -0.37 μg/g | Standard Deviation 2.465 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -0.02 μg/g | Standard Deviation 2.327 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | 0.21 μg/g | Standard Deviation 2.321 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | -0.09 μg/g | Standard Deviation 2.023 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | 0.24 μg/g | Standard Deviation 2.242 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | -0.31 μg/g | Standard Deviation 2.114 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -0.16 μg/g | Standard Deviation 2.928 |
| Induction Period: PF-06480605 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | 0.60 μg/g | Standard Deviation 2.255 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | -0.60 μg/g | Standard Deviation 1.84 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | -0.15 μg/g | Standard Deviation 2.433 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -0.15 μg/g | Standard Deviation 2.409 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | -0.32 μg/g | Standard Deviation 2.516 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -0.21 μg/g | Standard Deviation 2.584 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | 0.02 μg/g | Standard Deviation 1.779 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | -0.98 μg/g | Standard Deviation 2.089 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | -0.78 μg/g | Standard Deviation 2.542 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 9.03 μg/g | Standard Deviation 2.765 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | 0.26 μg/g | Standard Deviation 2.247 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -0.12 μg/g | Standard Deviation 1.386 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | 0.29 μg/g | Standard Deviation 1.834 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | 0.35 μg/g | Standard Deviation 2.179 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | 0.09 μg/g | Standard Deviation 2.558 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | 0.36 μg/g | Standard Deviation 2.638 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | 0.43 μg/g | Standard Deviation 1.403 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | 0.10 μg/g | Standard Deviation 3.982 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | 0.50 μg/g | Standard Deviation 2.152 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 7.72 μg/g | Standard Deviation 2.642 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | 0.09 μg/g | Standard Deviation 3.32 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | 0.17 μg/g | Standard Deviation 2.939 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | 0.03 μg/g | Standard Deviation 1.996 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | 0.31 μg/g | Standard Deviation 2.453 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | 0.02 μg/g | Standard Deviation 2.568 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | -0.16 μg/g | Standard Deviation 1.874 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | 0.21 μg/g | Standard Deviation 2.377 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 9.34 μg/g | Standard Deviation 2.5 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | 0.01 μg/g | Standard Deviation 2.696 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | 0.85 μg/g | Standard Deviation 3.321 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | -0.32 μg/g | Standard Deviation 1.74 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -0.67 μg/g | Standard Deviation 1.889 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | -0.13 μg/g | Standard Deviation 2.192 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -0.20 μg/g | Standard Deviation 3.294 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -0.32 μg/g | Standard Deviation 2.44 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | 1.61 μg/g | Standard Deviation 1.426 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | 0.03 μg/g | Standard Deviation 3.027 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | 0.17 μg/g | Standard Deviation 2.102 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | -1.18 μg/g | Standard Deviation 4.08 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -0.61 μg/g | Standard Deviation 2.259 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | -0.42 μg/g | Standard Deviation 1.672 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -0.16 μg/g | Standard Deviation 1.716 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | -0.97 μg/g | Standard Deviation 1.89 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 8.39 μg/g | Standard Deviation 2.368 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | -0.54 μg/g | Standard Deviation 2.248 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | -0.91 μg/g | Standard Deviation 2.915 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | -0.30 μg/g | Standard Deviation 1.619 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -0.36 μg/g | Standard Deviation 2.362 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | 0.18 μg/g | Standard Deviation 2.569 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 32 | -0.08 μg/g | Standard Deviation 1.491 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 40 | -0.62 μg/g | Standard Deviation 2.434 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 36 | -0.32 μg/g | Standard Deviation 1.724 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 64 | -0.82 μg/g | Standard Deviation 2.007 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 60 | -0.95 μg/g | Standard Deviation 2.131 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 52 | -0.75 μg/g | Standard Deviation 2.355 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 24 | 0.10 μg/g | Standard Deviation 1.892 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 28 | -0.53 μg/g | Standard Deviation 2.136 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 44 | -0.69 μg/g | Standard Deviation 1.737 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 48 | -0.47 μg/g | Standard Deviation 2.15 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Week 16 | 9.21 μg/g | Standard Deviation 2.438 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Change From Week 16 in Fecal Calprotectin | Change From Week 16 at Week 20 | -0.46 μg/g | Standard Deviation 1.435 |
Secondary
Chronic Period: Number of Participants With ADA and NAbs to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5.
Time frame: Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60 and 64
Population: Evaluation of NAb is generally relevant only in participants who are positive for ADA. Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 11 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 11 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 10 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 0 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 1 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 2 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 11 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 9 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 10 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 4 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 2 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 10 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 3 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 11 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 10 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 9 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 3 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 0 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 11 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 11 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 4 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 2 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 3 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 2 Participants |
| Induction Period: Placebo | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 0 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 1 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 12 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 11 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 1 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 11 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 9 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 0 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 0 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 11 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 9 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 0 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 1 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 2 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 11 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 12 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 2 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 3 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 1 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 11 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 14 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 3 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 12 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 14 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 1 Participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 3 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 5 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 6 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 0 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 5 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 0 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 5 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 2 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 6 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 0 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 10 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 5 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 6 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 6 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 0 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 4 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 0 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 4 Participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 6 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 28 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 10 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 33 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 35 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 8 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 5 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 7 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 13 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 28 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 10 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 38 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 39 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 34 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 7 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 30 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 8 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 12 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 16 | 16 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 29 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 28 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 36 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 6 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 34 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 27 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 11 Participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 7 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 7 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 18 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 16 | 7 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 20 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 21 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 4 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 22 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 5 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 21 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 4 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 17 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 2 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 19 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 18 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 4 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 19 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 19 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 5 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 16 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 5 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 18 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 18 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 4 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 23 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 2 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 20 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 2 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 24 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 17 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 4 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 20 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 16 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 3 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 23 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 19 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 2 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 2 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 1 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 4 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 20 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 20 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 2 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 22 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 21 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 24 Participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 22 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 17 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 19 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 10 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 20 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 13 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 14 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 16 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 17 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 4 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 19 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 15 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 5 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 17 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 19 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 2 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 5 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 3 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 2 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 3 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 4 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 17 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 16 | 3 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 17 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 19 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 3 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 40 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 16 | 15 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 52 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 32 | 18 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 44 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 52 | 13 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 56 | 13 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 24 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 28 | 15 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 40 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 48 | 14 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 64 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 24 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 60 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 16 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 56 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 20 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 36 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 36 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 64 | 17 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 48 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 32 | 1 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 44 | 15 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | NAb at Week 28 | 0 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 60 | 16 Participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Number of Participants With ADA and NAbs to PF-06480605 | ADA at Week 20 | 16 Participants |
Secondary
Chronic Period: Percentage of Participants Who Achieved Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: At Week 56
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 33.3 percentage of participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 38.5 percentage of participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 35.7 percentage of participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 31.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 29.6 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 34.6 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 24.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 25.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Percentage of Participants Who Achieved Clinical Remission | 39.3 percentage of participants |
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore \>1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in the Placebo (Induction) to PF-06480605 50 mg (Chronic) met the remission criteria at Week 14. Hence, this arm has been excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 0 percentage of participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 25.0 percentage of participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 50.0 percentage of participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 50.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 62.5 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 28.6 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 50.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission | 85.7 percentage of participants |
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved improvement at Week 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 50.0 percentage of participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 0 percentage of participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 25.0 percentage of participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 47.4 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 80.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 61.5 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 46.2 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 63.6 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement | 80.0 percentage of participants |
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in Placebo (Induction) to PF-06480605 50 mg (Chronic) met remission criteria at Week 14. Hence, this arm has been excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 0 percentage of participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 0 percentage of participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 22.2 percentage of participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 50.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 25.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 66.7 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 50.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission | 66.7 percentage of participants |
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least 1 dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in Placebo (Induction) to PF-06480605 50 mg (Chronic) and Placebo (Induction) to PF-06480605 150 mg (Chronic) met remission criteria at Week 14. Hence, these arms have been excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 33.3 percentage of participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 28.6 percentage of participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 40.0 percentage of participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 66.7 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 25.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1) | 80.0 percentage of participants |
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Time frame: At Weeks 14 and 56
Population: Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 0 percentage of participants |
| Induction Period: PF-06480605 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 0 percentage of participants |
| Induction Period: PF-06480605 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 33.3 percentage of participants |
| Induction Period: PF-06480605 450 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 42.9 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 70.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 54.5 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 33.3 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 60.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2) | 75.0 percentage of participants |
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease \[erythema, decreased vascular pattern, mild friability\]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chrnoic Period: At Week 56
Population: Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 18.6 percentage of participants |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 40.4 percentage of participants |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 38.3 percentage of participants |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 40.9 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 66.7 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 38.5 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 42.9 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 38.1 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 37.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 39.3 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 36.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 37.5 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement | 50.0 percentage of participants |
p-value: 0.014690% CI: [4.14, 37.3]Chan and Zhang Method
p-value: 0.016790% CI: [2.76, 34.05]Chan and Zhang Method
p-value: 0.009490% CI: [3.22, 34.95]Chan and Zhang Method
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chronic Period: At Week 56
Population: Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 7.0 percentage of participants |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 19.1 percentage of participants |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 10.0 percentage of participants |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 10.2 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 16.7 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 23.1 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 28.6 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 11.9 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 7.4 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 7.1 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 16.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 8.3 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission | 21.4 percentage of participants |
p-value: 0.048990% CI: [0.05, 25.25]Chan and Zhang Method
p-value: 0.339690% CI: [-7.66, 12.88]Chan and Zhang Method
p-value: 0.399590% CI: [-7.42, 11.58]Chan and Zhang Method
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chronic Period: At Week 56
Population: Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 11.6 percentage of participants |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 29.8 percentage of participants |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 35.0 percentage of participants |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 31.8 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 50.0 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 30.8 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 35.7 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 31.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 33.3 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 38.5 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 28.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 33.3 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2) | 35.7 percentage of participants |
p-value: 0.018990% CI: [3.25, 32.23]Chan and Zhang Method
p-value: 0.004590% CI: [6.24, 36.28]Chan and Zhang Method
p-value: 0.011790% CI: [3.22, 31.31]Chan and Zhang Method
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Time frame: Induction Period: At Week 14; Chronic Period: At Week 56
Population: Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Induction Period: Placebo | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 7.0 percentage of participants |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 14.9 percentage of participants |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 13.3 percentage of participants |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 14.8 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 16.7 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 23.1 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 21.4 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 16.7 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 22.2 percentage of participants |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 23.1 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 16.0 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 20.8 percentage of participants |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1) | 17.9 percentage of participants |
p-value: 0.139890% CI: [-3.62, 20.04]Chan and Zhang Method
p-value: 0.203890% CI: [-4.88, 17.06]Chan and Zhang Method
p-value: 0.149890% CI: [-3.7, 17.06]Chan and Zhang Method
Secondary
Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605
Time frame: Induction Period: 30 mins postdose on Day 1, Weeks 4, 8, 12 and 14; Chronic Period: 30 mins postdose on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (Week 52) and Follow-up (FU) Visits 1 (Week 56), 2 (Week 60) and 3 (Week 64)
Population: Pharmacokinetic (PK) population included all participants randomly assigned to IP and received at least one dose of PF-06480605 for whom at least one concentration value was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 8 | 2232 nanograms per milliliter (ng/mL) | Standard Deviation 1858.5 |
| Induction Period: Placebo | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 12 | 2181 nanograms per milliliter (ng/mL) | Standard Deviation 2080.3 |
| Induction Period: Placebo | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 14 | 4198 nanograms per milliliter (ng/mL) | Standard Deviation 3252.9 |
| Induction Period: Placebo | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Day 1 | NA nanograms per milliliter (ng/mL) | — |
| Induction Period: Placebo | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 4 | 2251 nanograms per milliliter (ng/mL) | Standard Deviation 1122.5 |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 12 | 8914 nanograms per milliliter (ng/mL) | Standard Deviation 5425.9 |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Day 1 | 1.227 nanograms per milliliter (ng/mL) | Standard Deviation 6.7722 |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 8 | 8381 nanograms per milliliter (ng/mL) | Standard Deviation 4769.8 |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 4 | 6568 nanograms per milliliter (ng/mL) | Standard Deviation 3043.4 |
| Induction Period: PF-06480605 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 14 | 17110 nanograms per milliliter (ng/mL) | Standard Deviation 9380.6 |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 8 | 25160 nanograms per milliliter (ng/mL) | Standard Deviation 12194 |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 14 | 49480 nanograms per milliliter (ng/mL) | Standard Deviation 18086 |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 12 | 30900 nanograms per milliliter (ng/mL) | Standard Deviation 15724 |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Day 1 | 1.279 nanograms per milliliter (ng/mL) | Standard Deviation 10.209 |
| Induction Period: PF-06480605 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 4 | 19660 nanograms per milliliter (ng/mL) | Standard Deviation 8637.7 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 2672 nanograms per milliliter (ng/mL) | Standard Deviation 2275.6 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 1099 nanograms per milliliter (ng/mL) | Standard Deviation 2081.3 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 3478 nanograms per milliliter (ng/mL) | Standard Deviation 2422.7 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 3314 nanograms per milliliter (ng/mL) | Standard Deviation 2152.2 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 2921 nanograms per milliliter (ng/mL) | Standard Deviation 2084.1 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 2897 nanograms per milliliter (ng/mL) | Standard Deviation 1494.1 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 3532 nanograms per milliliter (ng/mL) | Standard Deviation 2447.9 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | NA nanograms per milliliter (ng/mL) | — |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 2793 nanograms per milliliter (ng/mL) | Standard Deviation 1893 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 2915 nanograms per milliliter (ng/mL) | Standard Deviation 2739.1 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 1550 nanograms per milliliter (ng/mL) | Standard Deviation 1580.2 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 2924 nanograms per milliliter (ng/mL) | Standard Deviation 1706.7 |
| Induction Period: PF-06480605 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 4152 nanograms per milliliter (ng/mL) | Standard Deviation 3804.3 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 10750 nanograms per milliliter (ng/mL) | Standard Deviation 8216 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 9346 nanograms per milliliter (ng/mL) | Standard Deviation 5199.5 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 10990 nanograms per milliliter (ng/mL) | Standard Deviation 8884.5 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 7587 nanograms per milliliter (ng/mL) | Standard Deviation 4748.7 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 6680 nanograms per milliliter (ng/mL) | Standard Deviation 4188 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 10520 nanograms per milliliter (ng/mL) | Standard Deviation 8027.4 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 1332 nanograms per milliliter (ng/mL) | Standard Deviation 2390.4 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 9279 nanograms per milliliter (ng/mL) | Standard Deviation 8345.1 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 240.4 nanograms per milliliter (ng/mL) | Standard Deviation 862.23 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 3797 nanograms per milliliter (ng/mL) | Standard Deviation 4065.6 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 9246 nanograms per milliliter (ng/mL) | Standard Deviation 6289.2 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 9755 nanograms per milliliter (ng/mL) | Standard Deviation 6903 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 10510 nanograms per milliliter (ng/mL) | Standard Deviation 10337 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 19390 nanograms per milliliter (ng/mL) | Standard Deviation 13334 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 46150 nanograms per milliliter (ng/mL) | Standard Deviation 19825 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 38270 nanograms per milliliter (ng/mL) | Standard Deviation 12846 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 43710 nanograms per milliliter (ng/mL) | Standard Deviation 26683 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 25030 nanograms per milliliter (ng/mL) | Standard Deviation 9240.1 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 49880 nanograms per milliliter (ng/mL) | Standard Deviation 21069 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 7976 nanograms per milliliter (ng/mL) | Standard Deviation 5279.5 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 41770 nanograms per milliliter (ng/mL) | Standard Deviation 18436 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 6.123 nanograms per milliliter (ng/mL) | Standard Deviation 22.077 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 29820 nanograms per milliliter (ng/mL) | Standard Deviation 15940 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 36520 nanograms per milliliter (ng/mL) | Standard Deviation 20234 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 45770 nanograms per milliliter (ng/mL) | Standard Deviation 20693 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 38950 nanograms per milliliter (ng/mL) | Standard Deviation 21386 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 3159 nanograms per milliliter (ng/mL) | Standard Deviation 2810.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 2516 nanograms per milliliter (ng/mL) | Standard Deviation 2279.8 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 2956 nanograms per milliliter (ng/mL) | Standard Deviation 3018.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 2613 nanograms per milliliter (ng/mL) | Standard Deviation 2763.5 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 2330 nanograms per milliliter (ng/mL) | Standard Deviation 2253.4 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 2802 nanograms per milliliter (ng/mL) | Standard Deviation 2573.3 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 2820 nanograms per milliliter (ng/mL) | Standard Deviation 2590.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 2867 nanograms per milliliter (ng/mL) | Standard Deviation 2655.4 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 2848 nanograms per milliliter (ng/mL) | Standard Deviation 3037 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 3246 nanograms per milliliter (ng/mL) | Standard Deviation 2965.2 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 1092 nanograms per milliliter (ng/mL) | Standard Deviation 1232.9 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 766.1 nanograms per milliliter (ng/mL) | Standard Deviation 2372.9 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 1969 nanograms per milliliter (ng/mL) | Standard Deviation 1932.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 3876 nanograms per milliliter (ng/mL) | Standard Deviation 3276.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 9613 nanograms per milliliter (ng/mL) | Standard Deviation 6568.8 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 3156 nanograms per milliliter (ng/mL) | Standard Deviation 2337.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 3374 nanograms per milliliter (ng/mL) | Standard Deviation 2922 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 3124 nanograms per milliliter (ng/mL) | Standard Deviation 2443.2 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 1025 nanograms per milliliter (ng/mL) | Standard Deviation 858.32 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 3417 nanograms per milliliter (ng/mL) | Standard Deviation 2301.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 257.3 nanograms per milliliter (ng/mL) | Standard Deviation 318.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 3608 nanograms per milliliter (ng/mL) | Standard Deviation 3088.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 3391 nanograms per milliliter (ng/mL) | Standard Deviation 2267.9 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 4811 nanograms per milliliter (ng/mL) | Standard Deviation 3089.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 5476 nanograms per milliliter (ng/mL) | Standard Deviation 4062.3 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 3385 nanograms per milliliter (ng/mL) | Standard Deviation 3540.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 12050 nanograms per milliliter (ng/mL) | Standard Deviation 7678.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 11500 nanograms per milliliter (ng/mL) | Standard Deviation 6289 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 4806 nanograms per milliliter (ng/mL) | Standard Deviation 2827.2 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 11790 nanograms per milliliter (ng/mL) | Standard Deviation 5931.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 12450 nanograms per milliliter (ng/mL) | Standard Deviation 7605.4 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 9840 nanograms per milliliter (ng/mL) | Standard Deviation 6630.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 12190 nanograms per milliliter (ng/mL) | Standard Deviation 6504.8 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 14580 nanograms per milliliter (ng/mL) | Standard Deviation 7988.8 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 11090 nanograms per milliliter (ng/mL) | Standard Deviation 6765.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 12870 nanograms per milliliter (ng/mL) | Standard Deviation 7884.4 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 13230 nanograms per milliliter (ng/mL) | Standard Deviation 7740.3 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 2011 nanograms per milliliter (ng/mL) | Standard Deviation 1752.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 11680 nanograms per milliliter (ng/mL) | Standard Deviation 6728.9 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 825.8 nanograms per milliliter (ng/mL) | Standard Deviation 1883.2 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 5465 nanograms per milliliter (ng/mL) | Standard Deviation 3299.1 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 10040 nanograms per milliliter (ng/mL) | Standard Deviation 6001.7 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 5894 nanograms per milliliter (ng/mL) | Standard Deviation 3973.7 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 4215 nanograms per milliliter (ng/mL) | Standard Deviation 3708.6 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 4610 nanograms per milliliter (ng/mL) | Standard Deviation 2651.5 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 39180 nanograms per milliliter (ng/mL) | Standard Deviation 19045 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 1285 nanograms per milliliter (ng/mL) | Standard Deviation 1436.1 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 3708 nanograms per milliliter (ng/mL) | Standard Deviation 2471.4 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 3900 nanograms per milliliter (ng/mL) | Standard Deviation 2874.5 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 19540 nanograms per milliliter (ng/mL) | Standard Deviation 10180 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 4494 nanograms per milliliter (ng/mL) | Standard Deviation 3860.2 |
| PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 4036 nanograms per milliliter (ng/mL) | Standard Deviation 3398.6 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 13930 nanograms per milliliter (ng/mL) | Standard Deviation 8673.4 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 18200 nanograms per milliliter (ng/mL) | Standard Deviation 12244 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 13410 nanograms per milliliter (ng/mL) | Standard Deviation 9499.7 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 12360 nanograms per milliliter (ng/mL) | Standard Deviation 7217.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 5266 nanograms per milliliter (ng/mL) | Standard Deviation 5457.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 12060 nanograms per milliliter (ng/mL) | Standard Deviation 8871.1 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 36320 nanograms per milliliter (ng/mL) | Standard Deviation 18215 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 1840 nanograms per milliliter (ng/mL) | Standard Deviation 2045.6 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 12920 nanograms per milliliter (ng/mL) | Standard Deviation 8418.9 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 13060 nanograms per milliliter (ng/mL) | Standard Deviation 8745.9 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 16890 nanograms per milliliter (ng/mL) | Standard Deviation 13735 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 13700 nanograms per milliliter (ng/mL) | Standard Deviation 10253 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 11830 nanograms per milliliter (ng/mL) | Standard Deviation 7571.4 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 44 | 36450 nanograms per milliliter (ng/mL) | Standard Deviation 12884 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 3 (Week 64) | 7136 nanograms per milliliter (ng/mL) | Standard Deviation 5642.6 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 16 | 32450 nanograms per milliliter (ng/mL) | Standard Deviation 17064 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 36 | 33660 nanograms per milliliter (ng/mL) | Standard Deviation 14185 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 48 | 38310 nanograms per milliliter (ng/mL) | Standard Deviation 13146 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 40 | 33660 nanograms per milliliter (ng/mL) | Standard Deviation 11189 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | EOT (Week 52) | 40710 nanograms per milliliter (ng/mL) | Standard Deviation 15146 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 32 | 36720 nanograms per milliliter (ng/mL) | Standard Deviation 16880 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 2 (Week 60) | 13930 nanograms per milliliter (ng/mL) | Standard Deviation 9036 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 20 | 34980 nanograms per milliliter (ng/mL) | Standard Deviation 17895 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 24 | 35110 nanograms per milliliter (ng/mL) | Standard Deviation 16669 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | FU Visit 1 (Week 56) | 43290 nanograms per milliliter (ng/mL) | Standard Deviation 17036 |
| PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg | Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605 | Postdose on Week 28 | 35080 nanograms per milliliter (ng/mL) | Standard Deviation 14331 |
Secondary
Induction Period: Change From Baseline in Fecal Calprotectin
Time frame: Baseline, Weeks 4, 8, and 12
Population: Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Induction Period: Change From Baseline in Fecal Calprotectin | Baseline | 10.62 micrograms per gram (µg/g) | Standard Deviation 2.145 |
| Induction Period: Placebo | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 4 | -0.32 micrograms per gram (µg/g) | Standard Deviation 2.294 |
| Induction Period: Placebo | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 8 | -0.77 micrograms per gram (µg/g) | Standard Deviation 2.601 |
| Induction Period: Placebo | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 12 | -0.62 micrograms per gram (µg/g) | Standard Deviation 3.208 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 4 | -0.38 micrograms per gram (µg/g) | Standard Deviation 1.973 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 8 | -1.28 micrograms per gram (µg/g) | Standard Deviation 2.62 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 12 | -1.36 micrograms per gram (µg/g) | Standard Deviation 2.837 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Baseline | 9.99 micrograms per gram (µg/g) | Standard Deviation 2.105 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 8 | -1.84 micrograms per gram (µg/g) | Standard Deviation 2.779 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 4 | -1.24 micrograms per gram (µg/g) | Standard Deviation 2.429 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 12 | -2.43 micrograms per gram (µg/g) | Standard Deviation 2.859 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Baseline | 10.78 micrograms per gram (µg/g) | Standard Deviation 2.12 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 12 | -1.44 micrograms per gram (µg/g) | Standard Deviation 3.003 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 4 | -0.86 micrograms per gram (µg/g) | Standard Deviation 2.618 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Baseline | 10.23 micrograms per gram (µg/g) | Standard Deviation 1.618 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Fecal Calprotectin | Change From Baseline at Week 8 | -1.69 micrograms per gram (µg/g) | Standard Deviation 2.991 |
Secondary
Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline, Weeks 4, 8, and 12
Population: Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline | 1.76 milligrams per deciliter (mg/dL) | Standard Deviation 2.135 |
| Induction Period: Placebo | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 4 | -0.49 milligrams per deciliter (mg/dL) | Standard Deviation 1.503 |
| Induction Period: Placebo | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 8 | -0.49 milligrams per deciliter (mg/dL) | Standard Deviation 1.929 |
| Induction Period: Placebo | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 12 | -0.96 milligrams per deciliter (mg/dL) | Standard Deviation 2.305 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 4 | -0.48 milligrams per deciliter (mg/dL) | Standard Deviation 1.669 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 8 | -0.45 milligrams per deciliter (mg/dL) | Standard Deviation 1.896 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 12 | -0.71 milligrams per deciliter (mg/dL) | Standard Deviation 1.764 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline | 1.47 milligrams per deciliter (mg/dL) | Standard Deviation 1.99 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 8 | -0.94 milligrams per deciliter (mg/dL) | Standard Deviation 2.12 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 4 | -0.75 milligrams per deciliter (mg/dL) | Standard Deviation 1.762 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 12 | -1.25 milligrams per deciliter (mg/dL) | Standard Deviation 1.748 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline | 1.41 milligrams per deciliter (mg/dL) | Standard Deviation 1.799 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 12 | -1.06 milligrams per deciliter (mg/dL) | Standard Deviation 1.834 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 4 | -1.08 milligrams per deciliter (mg/dL) | Standard Deviation 1.577 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline | 1.82 milligrams per deciliter (mg/dL) | Standard Deviation 1.924 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Change From Baseline at Week 8 | -1.09 milligrams per deciliter (mg/dL) | Standard Deviation 1.697 |
Secondary
Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)
Time frame: Baseline, Weeks 4, 8, and 12
Population: Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Induction Period: Placebo | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Baseline | 6.86 picograms per milliliter (pg/mL) | Standard Deviation 0.441 |
| Induction Period: Placebo | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 4 | 0.01 picograms per milliliter (pg/mL) | Standard Deviation 0.347 |
| Induction Period: Placebo | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 8 | -0.05 picograms per milliliter (pg/mL) | Standard Deviation 0.549 |
| Induction Period: Placebo | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 12 | -0.02 picograms per milliliter (pg/mL) | Standard Deviation 0.371 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 4 | 3.45 picograms per milliliter (pg/mL) | Standard Deviation 1.097 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 8 | 3.14 picograms per milliliter (pg/mL) | Standard Deviation 1.34 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 12 | 2.86 picograms per milliliter (pg/mL) | Standard Deviation 1.666 |
| Induction Period: PF-06480605 50 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Baseline | 6.74 picograms per milliliter (pg/mL) | Standard Deviation 0.499 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 8 | 3.80 picograms per milliliter (pg/mL) | Standard Deviation 1.486 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 4 | 3.85 picograms per milliliter (pg/mL) | Standard Deviation 1.294 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 12 | 3.72 picograms per milliliter (pg/mL) | Standard Deviation 1.53 |
| Induction Period: PF-06480605 150 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Baseline | 6.77 picograms per milliliter (pg/mL) | Standard Deviation 0.534 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 12 | 4.71 picograms per milliliter (pg/mL) | Standard Deviation 1.908 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 4 | 4.91 picograms per milliliter (pg/mL) | Standard Deviation 0.834 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Baseline | 6.83 picograms per milliliter (pg/mL) | Standard Deviation 0.558 |
| Induction Period: PF-06480605 450 mg | Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A) | Change From Baseline at Week 8 | 4.88 picograms per milliliter (pg/mL) | Standard Deviation 1.294 |
Secondary
Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was \< 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was \< 5.
Time frame: Baseline, Weeks 4, 8, 12, 14
Population: Evaluation of NAb is generally relevant only in participants who are positive for ADA. Immunogenicity analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one post-treatment ADA determination was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Baseline | 0 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 4 | 29 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 4 | 1 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 8 | 39 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 8 | 10 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 12 | 41 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 12 | 12 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 14 | 41 Participants |
| Induction Period: Placebo | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 14 | 14 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 14 | 35 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 8 | 4 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Baseline | 1 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 8 | 34 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Baseline | 0 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 14 | 7 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 12 | 7 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 4 | 16 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 12 | 36 Participants |
| Induction Period: PF-06480605 50 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 4 | 0 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 12 | 3 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 4 | 0 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 8 | 34 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 8 | 1 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 14 | 33 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 12 | 36 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Week 14 | 3 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Baseline | 2 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | NAb at Baseline | 0 Participants |
| Induction Period: PF-06480605 150 mg | Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605 | ADA at Week 4 | 24 Participants |