Hidradenitis Suppurativa Study of Izokibep

Primary Outcome Measures

1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12
   The percentage of participants achieving HiSCR75 was defined as meeting all 3 criteria below: * (\[abscess and inflammatory nodule (AN) count at baseline - AN count at current visit\] / AN count at baseline) × 100% ≥ 75% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR75 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.

Secondary Outcome Measures

1. Percentage of Participants Achieving HiSCR90 at Week 12
   The percentage of participants achieving HiSCR90 was defined as meeting all 3 criteria below: * (\[AN count at baseline - AN count at current visit\] / AN count at baseline) × 100% ≥ 90% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR90 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.
2. Percentage of Participants Achieving HiSCR100 at Week 12
   The percentage of participants achieving HiSCR100 was defined as meeting all 3 criteria below: * (\[AN count at baseline - AN count at current visit\] / AN count at baseline) × 100% = 100% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR100 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.
3. Percentage of Participants Achieving HiSCR50 at Week 12
   The percentage of participants achieving HiSCR50 was defined as meeting all 3 criteria below: * \[(AN count at baseline - AN count at current visit) / AN count at baseline\] × 100% ≥ 50% * Abscess count at baseline ≥ abscess count at the current visit * Draining fistula count at baseline ≥ draining fistula count at the current visit. HiSCR50 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.
4. Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12
   HS flares were defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline, i.e. participants must meet all the following criteria: * (AN count at current visit- AN count at baseline) / AN count at baseline ×100% ≥ 25% * AN count at current visit- AN count at baseline ≥ 2. Participants who received antibiotic therapy that could affect HS were imputed as non-response (NRI). Other participants with missing data were imputed with multiple imputation.
5. Change From Baseline in Dermatology Life Quality Index (DLQI)
   DLQI included 10 items arranged in 6 categories: symptoms and feelings, daily activity, leisure, work or study, interpersonal relationships, and treatment. The total score could range from 0 (no impact to life quality) to 30 (maximum impact).
6. Percentage of Participants With Baseline Hurley Stage II Who Achieved AN Count of 0, 1, or 2 at Week 12
   Calculated as observed values of 0, 1, or 2 for AN count (abscess count + inflammatory nodule count). AN count of 0, 1, or 2 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.
7. Percentage of Participants With Baseline NRS ≥ 4 Achieving at Least 3-point Reduction at Week 12 in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at Its Worst
   NRS in Patient Global Assessment of Skin Pain ranged from 0 (no skin pain) to 10 (skin pain bad as you can imagine). The skin pain score at each visit was calculated using average of daily scores among the 7 days up to and including the day of visit, with a minimum of 4 days (consecutive or non-consecutive) with scores required. Reduction in NRS was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.
8. Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1
   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. The following events of special interest were monitored in this study: candida infection; inflammatory bowel disease (IBD); suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events; tuberculosis; infections; cytopenias and systemic hypersensitivity reactions. Clinically significant changes in vital signs and laboratory tests recorded after treatment administration were documented as TEAEs.
9. Number of Participants With TEAEs, SAEs and AESIs in Period 2
   An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. The following events of special interest were monitored in this study: candida infection; IBD; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events; tuberculosis; infections; cytopenias and systemic hypersensitivity reactions. Clinically significant changes in vital signs and laboratory tests recorded after treatment administration were documented as TEAEs.