Hidradenitis Suppurativa Phase 2b Study of Izokibep

Part B: Number of Participants Who Achieved HiSCR100 at Week 16

HiSCR100 was defined as at least a 100% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.

Time frame: Part B: Baseline to Week 16

Part B: Number of Participants Who Achieved HiSCR50 at Week 16

HiSCR50 was defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count

Time frame: Part B: Baseline to Week 16

Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment

A flare was defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline. Missing data of abscess and inflammatory nodules counts at scheduled visits are imputed assuming monotone missingness pattern. Predictors in the regression model for missing values at Week 4 are Baseline Hurley stage, baseline abscess count, baseline inflammatory nodule count, baseline draining fistula count, sex, race, age, body mass index (BMI) and prior Biologic/JAK inhibitor use for HS. Predictors in the regression model for missing values after Week 4 are all of these variables, plus counts of abscess, inflammatory nodule, and draining fistula at prior scheduled assessment. Missing flare values in both the placebo and izokibep groups are imputed using observed data from the placebo group only.

Time frame: Part B: Day 1 through to Week 16

Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2

The percentage of participants with baseline Hurley Stage II who achieved AN count of 0, 1, or 2 at Week 16. Hurley stages: Stage 1 - solitary or multiple, isolated abscess formation without scarring or sinus tracts Stage 2 - recurrent abscesses, single or multiple widely separated lesions, with sinus tract formation Stage 3 - diffuse or broad involvement, with multiple interconnected sinus tracts and abscesses.

Time frame: Part B: Week 16

Part B: Number of Participants Who Achieved at Least a 3-Point Reduction From Baseline in Numeric Rating Scale (NRS) in Patient Global Assessment of Skin Pain at Its Worst at Week 16 Among Participants With Baseline NRS ≥ 4

The Patient Global Assessment of Skin Pain is a NRS that consists of scores from 0 to 10 with 0 indicating "no skin pain" and 10 indicating "pain as bad as you can imagine".

Time frame: Part B: Baseline to Week 16

Part B: Number of Participants With TEAEs of Special Interest

Adverse events of special interest were adverse events in the following categories: candida infection, inflammatory bowel disease, suicidal ideation, malignancies, major cardiovascular and cerebrovascular events, tuberculosis, infections, cytopenias and hypersensitivity reactions.

Time frame: Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks

Part B: Number of Participants With TEAEs

An AE referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. SAEs were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events.

Time frame: Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks

Part B: Number of Participants Testing Positive for ADAs

Blood samples were collected at different time points throughout the study.

Time frame: Up to 39 weeks