Hidradenitis Suppurativa, Acne Inversa
Conditions
Keywords
Avacopan, ChemoCentryx, Skin Disease, Inflammatory nodule, Abscess, Sinus formation, Fistula formation
Brief summary
Phase 2 study of Avacopan in Subjects with Moderate to Severe Hidradenitis Suppurativa
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 study in subjects with moderate to severe Hidradenitis Suppurativa. The study is multicenter and will consist of three subject groups. Subjects will be randomized 1:1:1 to a treatment of 10mg avacopan twice daily, 30 mg avacopan twice daily or placebo twice daily for 12 weeks. Following the 12 weeks double-blind treatment period, subjects on placebo will be re-randomized 1:1 to receive 10 mg or 30 mg avacopan twice daily for additional 24 weeks. Subjects treated with avacopan will continue to receive the same dose (either 10 mg or 30 mg twice daily) for additional 24 weeks. Subjects will be on study treatment for 36 weeks and will be followed for 44 weeks for assessment of safety and efficacy. Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx. Primary efficacy analysis will be at 12 weeks.
Interventions
DRUGAvacopan
Active treatment
OTHERPlacebo
Placebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Clinical diagnosis of HS (Hurley Stage II or III), confirmed by a dermatologist, for at least 6 months prior to Screening * HS lesions are present in at least 2 distinct anatomic areas * Inadequate or loss of response to a systemic course of antibiotics typically of at least 90 days * Must have at least 5 inflammatory nodules or abscesses at screening * Use adequate birth control for subject and partners of child bearing potential * Willing and able to give written Informed Consent
Exclusion criteria
* Pregnant or breast-feeding * Any other skin disease that may interfere with the assessment of HS * Rapidly progressive, expanding HS within 30 days prior to screening * More than 20 draining fistulae at screening * Any anti-TNF-α treatment for HS or for other conditions prior to Day 1 visit will be prohibited. Exception: Subjects who were previously treated with an anti-TNF-α drug and discontinued treatment \>12 weeks prior to Day 1 visit are allowed for enrollment * Systemic antibiotics are generally excluded * Topical antibiotics use within 14 days prior to Day 1 is excluded * Have started a topical prescription medicine for HS within 14 days prior to screening * A systemic medicine for HS, including biologics and other systemic therapies * Have received within 14 days prior to Day 1 visit or is expected to require oral or transdermal opioid analgesics (except for tramadol) for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | Baseline to Week 12 | The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12 | Baseline to Week 12 | NRS30 = The number of responders achieving at least 30% reduction and at least 1 unit reduction from baseline in the subject's global assessment of skin pain score. Percentage is based on the number of subjects with a baseline pain score of at least 3 in each treatment group. Weekly averages of daily pain will be calculated based on subjects' daily diary recording of the worst pain experienced in the previous 24 hours. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation |
| Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1 | Day 1 | The Area under the curve from Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 plasma concentration on Day 1 in the PK population. PK- pharmacokinetics |
| Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12 | Baseline and Week 12 | The number of responders With Baseline Hurley Stage II Who Achieved an Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 using the NRI-CMH Test in the ITT1 population. Hurley Stage II disease is defined as having 1 or more widely separated recurrent abscesses with tract formation and scars. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. |
| Change of IHS4 Score Relative to Baseline at Week 12. | Baseline and Week 12 | The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS. IHS4- International HS Severity Scoring System |
| Change From Baseline in Total AN Count at Week 12 | Baseline to Week 12 | The Change from Baseline in total AN (abscess and inflammatory nodule) count at Week 12 using MMRM and OC in the ITT1 population. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. MMRM - mixed effects model for repeated measures; OC- observed case |
| Change From Baseline in Abscess Count at Week 12 | Baseline and Week 12 | A reduction in abscess count signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. |
| Change From Baseline in Draining Fistula Count at Week 12 | Baseline and Week 2, Week 4, Week 8 and Week 12 | The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. |
| Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Baseline and Week 2, Week 4, Week 8 and Week 12 | Twelve body areas will be evaluated to calculate the Sartorius and modified Sartorius scores: left and right axillae, left and right inframammary areas, intermammary area, left and right buttocks, left and right inguinocrural folds, perianal area, perineal area, and other. The presence of nodules, abscesses, fistulae, scars, and other findings will be recorded. The longest distance between two lesions and whether lesions are separated by normal skin is recorded. A score of 4 indicates the least severe disease, and higher scores indicate increasingly severe disease. There is no upper limit in the score. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. |
| Change From Baseline in Inflammatory Nodule Count at Week 12 | Baseline and Week 12 | A reduction in AN signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Period 1- Placebo BID for 12 Weeks | 130 |
| Group B Avacopan 10 mg twice daily (BID) for Period 1+2 of the study | 134 |
| Group C Avacopan 30 mg twice daily (BID) for Period 1+2 of the study | 134 |
| Total | 398 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Period 1 - 12 Weeks | Adverse Event | 4 | 6 | 4 | 0 | 0 |
| Period 1 - 12 Weeks | At the discretion of the investigator or sponsor for any reason | 0 | 3 | 0 | 0 | 0 |
| Period 1 - 12 Weeks | Lost to Follow-up | 5 | 5 | 7 | 0 | 0 |
| Period 1 - 12 Weeks | Noncompliance with the protocol | 2 | 0 | 4 | 0 | 0 |
| Period 1 - 12 Weeks | Reason not stated | 2 | 1 | 0 | 0 | 0 |
| Period 1 - 12 Weeks | Subject noncompliance with dosing or diary completion | 0 | 1 | 3 | 0 | 0 |
| Period 1 - 12 Weeks | Withdrawal by Subject | 8 | 10 | 7 | 0 | 0 |
| Period 2 - Week 44 | Adverse Event | 0 | 3 | 1 | 2 | 2 |
| Period 2 - Week 44 | At the discretion of the investigator or sponsor for any reason | 0 | 1 | 3 | 2 | 3 |
| Period 2 - Week 44 | COVID-19 Related | 0 | 0 | 0 | 1 | 0 |
| Period 2 - Week 44 | Lost to Follow-up | 0 | 8 | 12 | 1 | 2 |
| Period 2 - Week 44 | Noncompliance with the protocol | 0 | 2 | 1 | 0 | 0 |
| Period 2 - Week 44 | Reason not stated | 0 | 0 | 0 | 0 | 1 |
| Period 2 - Week 44 | Subject noncompliance with dosing or diary completion | 0 | 2 | 1 | 1 | 0 |
| Period 2 - Week 44 | Withdrawal by Subject | 0 | 22 | 15 | 10 | 10 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Total |
|---|---|---|---|---|
| Age, Continuous | 36.9 years STANDARD_DEVIATION 11.87 | 36.0 years STANDARD_DEVIATION 12.05 | 36.8 years STANDARD_DEVIATION 11.57 | 36.6 years STANDARD_DEVIATION 11.81 |
| BMI | 36.87 kg/m² STANDARD_DEVIATION 8.824 | 36.14 kg/m² STANDARD_DEVIATION 8.728 | 36.75 kg/m² STANDARD_DEVIATION 9.384 | 36.58 kg/m² STANDARD_DEVIATION 8.969 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 22 Participants | 39 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 112 Participants | 95 Participants | 306 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 166.69 cm STANDARD_DEVIATION 8.696 | 168.67 cm STANDARD_DEVIATION 9.852 | 167.66 cm STANDARD_DEVIATION 9.021 | 167.69 cm STANDARD_DEVIATION 9.221 |
| HS Disease Duration from Time of Diagnosis | 11.06 years STANDARD_DEVIATION 10.275 | 10.64 years STANDARD_DEVIATION 8.733 | 11.21 years STANDARD_DEVIATION 9.521 | 10.97 years STANDARD_DEVIATION 9.502 |
| Hurley Stage of HS Stage II | 85 Participants | 84 Participants | 87 Participants | 256 Participants |
| Hurley Stage of HS Stage III | 45 Participants | 50 Participants | 47 Participants | 142 Participants |
| IHS4 Score | 29.6 score on a scale STANDARD_DEVIATION 29.34 | 33.8 score on a scale STANDARD_DEVIATION 31.95 | 30.0 score on a scale STANDARD_DEVIATION 25.02 | 31.2 score on a scale STANDARD_DEVIATION 28.9 |
| Number of AN Count | 11.6 abscess and inflammatory nodules STANDARD_DEVIATION 9.83 | 13.5 abscess and inflammatory nodules STANDARD_DEVIATION 13.41 | 12.3 abscess and inflammatory nodules STANDARD_DEVIATION 9.62 | 12.5 abscess and inflammatory nodules STANDARD_DEVIATION 11.1 |
| Number of Draining Fistulae | 2.8 Draining Fistulae STANDARD_DEVIATION 3.83 | 3.2 Draining Fistulae STANDARD_DEVIATION 4.15 | 2.4 Draining Fistulae STANDARD_DEVIATION 3.73 | 2.8 Draining Fistulae STANDARD_DEVIATION 3.91 |
| Previously Started (allowed) Concomitant Antibiotic No | 122 Participants | 125 Participants | 127 Participants | 374 Participants |
| Previously Started (allowed) Concomitant Antibiotic Yes | 8 Participants | 9 Participants | 7 Participants | 24 Participants |
| Previous TNF Inhibitor Use No | 95 Participants | 96 Participants | 98 Participants | 289 Participants |
| Previous TNF Inhibitor Use Yes | 35 Participants | 38 Participants | 36 Participants | 109 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 46 Participants | 34 Participants | 123 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) White | 83 Participants | 82 Participants | 96 Participants | 261 Participants |
| Sex: Female, Male Female | 23 Participants | 30 Participants | 28 Participants | 81 Participants |
| Sex: Female, Male Male | 107 Participants | 104 Participants | 106 Participants | 317 Participants |
| Subject's Global Assessment of Skin Pain NRS | 5.6 score on a scale STANDARD_DEVIATION 2.52 | 5.3 score on a scale STANDARD_DEVIATION 2.54 | 5.2 score on a scale STANDARD_DEVIATION 2.47 | 5.4 score on a scale STANDARD_DEVIATION 2.51 |
| Weight | 102.48 kg STANDARD_DEVIATION 23.425 | 103.02 kg STANDARD_DEVIATION 27.817 | 103.46 kg STANDARD_DEVIATION 28.601 | 102.99 kg STANDARD_DEVIATION 26.678 |
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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 134 | 0 / 135 | 0 / 56 | 0 / 52 | 0 / 108 | 0 / 109 |
| other Total, other adverse events | 22 / 129 | 18 / 134 | 15 / 135 | 7 / 56 | 8 / 52 | 21 / 108 | 20 / 109 |
| serious Total, serious adverse events | 3 / 129 | 3 / 134 | 1 / 135 | 0 / 56 | 1 / 52 | 4 / 108 | 2 / 109 |
Outcome results
Primary
Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12.
The percentage of subjects achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 in the ITT1 population using the NRI-CMH Test. A response was defined as a reduction of at least 50 in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count compared with baseline. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation; CMH- Cochran-Mantel-Haenszel. Percentage values have been reported as opposed to proportion values to allow for statistical analyses.
Time frame: Baseline to Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | 30.8 percentage of participants |
| Avacopan 10 mg | Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | 22.4 percentage of participants |
| Avacopan 30 mg | Percentage of Subjects Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12. | 35.1 percentage of participants |
p-value: 0.132195% CI: [-18.7, 2.4]Cochran-Mantel-Haenszel
p-value: 0.450395% CI: [-6.9, 15.5]Cochran-Mantel-Haenszel
Secondary
Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1
The Area under the curve from Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 plasma concentration on Day 1 in the PK population. PK- pharmacokinetics
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1 | 18.0 h*ng/mL | Standard Deviation 8.23 |
| Avacopan 10 mg | Area Under the Curve From Time 0-3hrs (AUC 0-3hrs) of Metabolite M1 Plasma Concentration on Day 1 | 50.3 h*ng/mL | Standard Deviation 34.3 |
Secondary
Change From Baseline in Abscess Count at Week 12
A reduction in abscess count signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Abscess Count at Week 12 | -0.8 count of abscesses | Standard Deviation 3.68 |
| Avacopan 10 mg | Change From Baseline in Abscess Count at Week 12 | -0.8 count of abscesses | Standard Deviation 3.38 |
| Avacopan 30 mg | Change From Baseline in Abscess Count at Week 12 | -1.2 count of abscesses | Standard Deviation 2.73 |
Secondary
Change From Baseline in Draining Fistula Count at Week 12
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Time frame: Baseline and Week 2, Week 4, Week 8 and Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Draining Fistula Count at Week 12 | Week 2 | -0.3 Draining Fistulae | Standard Deviation 2.23 |
| Placebo | Change From Baseline in Draining Fistula Count at Week 12 | Week 12 | -0.6 Draining Fistulae | Standard Deviation 2.11 |
| Placebo | Change From Baseline in Draining Fistula Count at Week 12 | Week 8 | -0.4 Draining Fistulae | Standard Deviation 1.82 |
| Placebo | Change From Baseline in Draining Fistula Count at Week 12 | Week 4 | -0.5 Draining Fistulae | Standard Deviation 2.17 |
| Avacopan 10 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 4 | -0.8 Draining Fistulae | Standard Deviation 2.88 |
| Avacopan 10 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 8 | -0.9 Draining Fistulae | Standard Deviation 2.93 |
| Avacopan 10 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 12 | -0.9 Draining Fistulae | Standard Deviation 2.57 |
| Avacopan 10 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 2 | -0.5 Draining Fistulae | Standard Deviation 2.22 |
| Avacopan 30 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 12 | -0.5 Draining Fistulae | Standard Deviation 1.87 |
| Avacopan 30 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 2 | -0.4 Draining Fistulae | Standard Deviation 1.79 |
| Avacopan 30 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 8 | -0.6 Draining Fistulae | Standard Deviation 2.03 |
| Avacopan 30 mg | Change From Baseline in Draining Fistula Count at Week 12 | Week 4 | -0.4 Draining Fistulae | Standard Deviation 2.16 |
Secondary
Change From Baseline in Inflammatory Nodule Count at Week 12
A reduction in AN signifies improvement. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Inflammatory Nodule Count at Week 12 | -2.4 count of inflammatory nodules | Standard Deviation 7.48 |
| Avacopan 10 mg | Change From Baseline in Inflammatory Nodule Count at Week 12 | -2.5 count of inflammatory nodules | Standard Deviation 9.17 |
| Avacopan 30 mg | Change From Baseline in Inflammatory Nodule Count at Week 12 | -3.9 count of inflammatory nodules | Standard Deviation 7.06 |
Secondary
Change From Baseline in Total AN Count at Week 12
The Change from Baseline in total AN (abscess and inflammatory nodule) count at Week 12 using MMRM and OC in the ITT1 population. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. MMRM - mixed effects model for repeated measures; OC- observed case
Time frame: Baseline to Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Total AN Count at Week 12 | -3.1 percentage of ANs | Standard Deviation 8.57 |
| Avacopan 10 mg | Change From Baseline in Total AN Count at Week 12 | -3.4 percentage of ANs | Standard Deviation 10.58 |
| Avacopan 30 mg | Change From Baseline in Total AN Count at Week 12 | -5.1 percentage of ANs | Standard Deviation 8.41 |
p-value: 0.578495% CI: [-1.7, 2.9]Mixed model for repeated measures
p-value: 0.225395% CI: [-3.7, 0.9]Mixed effects model for repeated measure
Secondary
Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS
Twelve body areas will be evaluated to calculate the Sartorius and modified Sartorius scores: left and right axillae, left and right inframammary areas, intermammary area, left and right buttocks, left and right inguinocrural folds, perianal area, perineal area, and other. The presence of nodules, abscesses, fistulae, scars, and other findings will be recorded. The longest distance between two lesions and whether lesions are separated by normal skin is recorded. A score of 4 indicates the least severe disease, and higher scores indicate increasingly severe disease. There is no upper limit in the score. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Time frame: Baseline and Week 2, Week 4, Week 8 and Week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 2 | -3.0 score on a scale | Standard Deviation 21.02 |
| Placebo | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 4 | -5.7 score on a scale | Standard Deviation 23.7 |
| Placebo | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 8 | -9.8 score on a scale | Standard Deviation 32.6 |
| Placebo | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 12 | -11.2 score on a scale | Standard Deviation 35.69 |
| Avacopan 10 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 12 | -12.6 score on a scale | Standard Deviation 25.98 |
| Avacopan 10 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 2 | -3.5 score on a scale | Standard Deviation 16.68 |
| Avacopan 10 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 8 | -11.5 score on a scale | Standard Deviation 23.64 |
| Avacopan 10 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 4 | -7.2 score on a scale | Standard Deviation 22.84 |
| Avacopan 30 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 12 | -14.4 score on a scale | Standard Deviation 29.96 |
| Avacopan 30 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 4 | -6.5 score on a scale | Standard Deviation 21.37 |
| Avacopan 30 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 8 | -10.4 score on a scale | Standard Deviation 26.43 |
| Avacopan 30 mg | Change From Baseline to Week 12 in the Modified Sartorius Score to Quantify the Severity Change of HS | Week 2 | -6.3 score on a scale | Standard Deviation 17.72 |
Secondary
Change of IHS4 Score Relative to Baseline at Week 12.
The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS. IHS4- International HS Severity Scoring System
Time frame: Baseline and Week 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change of IHS4 Score Relative to Baseline at Week 12. | -6.4 score on a scale | Standard Deviation 16.99 |
| Avacopan 10 mg | Change of IHS4 Score Relative to Baseline at Week 12. | -7.9 score on a scale | Standard Deviation 22.14 |
| Avacopan 30 mg | Change of IHS4 Score Relative to Baseline at Week 12. | -9.8 score on a scale | Standard Deviation 15.69 |
Secondary
Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12
NRS30 = The number of responders achieving at least 30% reduction and at least 1 unit reduction from baseline in the subject's global assessment of skin pain score. Percentage is based on the number of subjects with a baseline pain score of at least 3 in each treatment group. Weekly averages of daily pain will be calculated based on subjects' daily diary recording of the worst pain experienced in the previous 24 hours. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1. NRI- non-responder imputation
Time frame: Baseline to Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12 | 26 number of responders |
| Avacopan 10 mg | Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12 | 23 number of responders |
| Avacopan 30 mg | Number of Responders Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in the Subject's Global Assessment of Skin Pain (NRS30) in Subjects With a Baseline NRS of at Least 3, Evaluated at Week 12 | 17 number of responders |
Secondary
Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12
The number of responders With Baseline Hurley Stage II Who Achieved an Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12 using the NRI-CMH Test in the ITT1 population. Hurley Stage II disease is defined as having 1 or more widely separated recurrent abscesses with tract formation and scars. The ITT1 population was defined as all subjects who were randomized at baseline and received at least 1 dose of investigational product during period 1.
Time frame: Baseline and Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12 | 29 number of responders |
| Avacopan 10 mg | Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12 | 15 number of responders |
| Avacopan 30 mg | Number of Responders With Baseline Hurley Stage II Who Achieved an AN Count of 0, 1, or 2 at Week 12 | 20 number of responders |