Trial Outcomes & Findings for Hidradenitis Suppurativa Phase 2b Study of Izokibep (NCT NCT05355805)

Last Updated: 2025-06-03

Results Overview

HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

205 participants

Primary outcome timeframe

Part A: Baseline to Week 12

Results posted on

2025-06-03

Participant Flow

Participants were recruited at different centers in the United States, Canada, Germany, Hungary, Poland, and Spain, and participated from May 2022 to February 2024.

Part A was a single-arm, open-label, proof-of-concept investigation to explore preliminary efficacy and safety of izokibep. Once Part A was fully enrolled, subsequent participants were enrolled into Part B. Part B was a randomized, double-blind, placebo-controlled, parallel-group, dose-finding investigation to evaluate the efficacy, safety, and immunogenicity of izokibep in participants with moderate to severe hidradenitis suppurativa.

Participant milestones

Participant milestones
Measure	Part A Izokibep 160 mg QW (Open-label) Participants with moderate to severe Hidradenitis Suppurativa (HS) received open label izokibep 160 mg by subcutaneous (SC) injection once every week (QW) in Part A for up to 31 weeks.	Part B Placebo QW/Q2W Then Izokibep QW/Q2W Participants with moderate to severe HS received placebo by SC injection either QW or every 2 weeks (Q2W) up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W for up to Week 30.	Part B Izokibep 160 mg QW Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Overall Study STARTED	30	59	57	59
Overall Study Switched to Izokibep 160 mg QW	0	24	0	0
Overall Study Switched to Izokibep 160 mg Q2W	0	26	0	0
Overall Study COMPLETED	17	34	31	40
Overall Study NOT COMPLETED	13	25	26	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A Izokibep 160 mg QW (Open-label) Participants with moderate to severe Hidradenitis Suppurativa (HS) received open label izokibep 160 mg by subcutaneous (SC) injection once every week (QW) in Part A for up to 31 weeks.	Part B Placebo QW/Q2W Then Izokibep QW/Q2W Participants with moderate to severe HS received placebo by SC injection either QW or every 2 weeks (Q2W) up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W for up to Week 30.	Part B Izokibep 160 mg QW Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.
Overall Study Lost to Follow-up	6	11	10	6
Overall Study Decision by Sponsor	0	0	1	0
Overall Study Withdrawal by Subject	7	14	15	13

Baseline Characteristics

Participants in Part A and Part B of the study were analyzed separately

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A Izokibep 160 mg QW n=30 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Placebo QW/Q2W Then Izokibep QW/Q2W n=59 Participants Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks. After Week 16, participants who received placebo QW switched to izokibep QW up to Week 31. Participants who received placebo Q2W switched to izokibep Q2W up to Week 30.	Part B Izokibep 160 mg QW n=57 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=59 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Total n=205 Participants Total of all reporting groups
Age, Categorical Part A · <=18 years	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Age, Categorical Part A · Between 18 and 65 years	30 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	30 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Age, Categorical Part A · >=65 years	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Age, Categorical Part B · <=18 years	—	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Age, Categorical Part B · Between 18 and 65 years	—	58 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	56 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	58 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	172 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Age, Categorical Part B · >=65 years	—	1 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	1 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	1 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	3 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Age, Continuous Part A	38.3 years STANDARD_DEVIATION 9.68 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	38.3 years STANDARD_DEVIATION 9.68 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Age, Continuous Part B	—	37.2 years STANDARD_DEVIATION 11.45 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	35.3 years STANDARD_DEVIATION 11.66 • n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	40.3 years STANDARD_DEVIATION 10.04 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	37.6 years STANDARD_DEVIATION 11.2 • n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Sex: Female, Male Part A · Female	21 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	21 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Sex: Female, Male Part A · Male	9 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	9 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Sex: Female, Male Part B · Female	—	40 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	39 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	36 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	115 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Sex: Female, Male Part B · Male	—	19 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	18 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	23 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	60 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Ethnicity (NIH/OMB) Part A · Hispanic or Latino	4 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	4 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Ethnicity (NIH/OMB) Part A · Not Hispanic or Latino	26 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	26 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Ethnicity (NIH/OMB) Part A · Unknown or Not Reported	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Ethnicity (NIH/OMB) Part B · Hispanic or Latino	—	9 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	11 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	7 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	27 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Ethnicity (NIH/OMB) Part B · Not Hispanic or Latino	—	50 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	46 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	52 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	148 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Ethnicity (NIH/OMB) Part B · Unknown or Not Reported	—	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part A · American Indian or Alaska Native	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part A · Asian	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part A · Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part A · Black or African American	14 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	14 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part A · White	16 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	16 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part A · More than one race	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part A · Unknown or Not Reported	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	0 Participants n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part B · American Indian or Alaska Native	—	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	1 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	1 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part B · Asian	—	1 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	3 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	4 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part B · Native Hawaiian or Other Pacific Islander	—	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part B · Black or African American	—	9 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	7 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	6 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	22 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part B · White	—	47 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	45 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	51 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	143 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part B · More than one race	—	2 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	1 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	2 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	5 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Race (NIH/OMB) Part B · Unknown or Not Reported	—	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	0 Participants n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Abscess Count Part A	1.7 Abcesses STANDARD_DEVIATION 2.18 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	1.7 Abcesses STANDARD_DEVIATION 2.18 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Abscess Count Part B	—	1.8 Abcesses STANDARD_DEVIATION 2.10 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	1.9 Abcesses STANDARD_DEVIATION 3.57 • n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	1.9 Abcesses STANDARD_DEVIATION 4.86 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	1.9 Abcesses STANDARD_DEVIATION 3.67 • n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Inflammatory Nodule Count Part A	8.8 Nodules STANDARD_DEVIATION 7.20 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	8.8 Nodules STANDARD_DEVIATION 7.20 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Inflammatory Nodule Count Part B	—	7.5 Nodules STANDARD_DEVIATION 5.10 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	10.0 Nodules STANDARD_DEVIATION 8.45 • n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	7.9 Nodules STANDARD_DEVIATION 4.21 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	8.5 Nodules STANDARD_DEVIATION 6.22 • n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Draining Fistula Count Part A	1.7 Fistulas STANDARD_DEVIATION 2.35 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	1.7 Fistulas STANDARD_DEVIATION 2.35 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Draining Fistula Count Part B	—	3.5 Fistulas STANDARD_DEVIATION 5.18 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	3.0 Fistulas STANDARD_DEVIATION 3.97 • n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	2.6 Fistulas STANDARD_DEVIATION 3.38 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	3.1 Fistulas STANDARD_DEVIATION 4.24 • n=175 Participants • Participants in Part A and Part B of the study were analyzed separately
Abcess and Inflammatory Nodule (AN) Count Part A	10.5 Total Abcess/Nodules STANDARD_DEVIATION 7.64 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately	—	—	—	10.5 Total Abcess/Nodules STANDARD_DEVIATION 7.64 • n=30 Participants • Participants in Part A and Part B of the study were analyzed separately
Abcess and Inflammatory Nodule (AN) Count Part B	—	9.3 Total Abcess/Nodules STANDARD_DEVIATION 5.24 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	11.9 Total Abcess/Nodules STANDARD_DEVIATION 9.50 • n=57 Participants • Participants in Part A and Part B of the study were analyzed separately	9.9 Total Abcess/Nodules STANDARD_DEVIATION 6.85 • n=59 Participants • Participants in Part A and Part B of the study were analyzed separately	10.4 Total Abcess/Nodules STANDARD_DEVIATION 7.42 • n=175 Participants • Participants in Part A and Part B of the study were analyzed separately

PRIMARY outcome

Timeframe: Part A: Baseline to Week 12

Population: FAS, Part A: all participants who received at lease one dose of study drug in Part A.

HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=30 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part A: Number of Participants Who Achieved Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12	12 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Part B: Baseline to Week 16

Population: FAS, Part B: all participants randomized in Part B.

HiSCR75 was defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=57 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=59 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants Who Achieved HiSCR75 at Week 16	16 Participants	21 Participants	19 Participants	—	—	—	—

SECONDARY outcome

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

Population: Safety analysis set (SAS): all participants who received at lease one dose of study drug in Part A.

An adverse event (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. Serious 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.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=30 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE	26 Participants	—	—	—	—	—	—
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Serious TEAE	2 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 16, Week 32, Week 39

Population: ADA Analysis Set: all participants who received at lease one dose of study drug and had both baseline ADA and at least one post-dose ADA measurement in Part A.

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

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=25 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs) Baseline	12 Participants	—	—	—	—	—	—
Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs) Week 16	11 Participants	—	—	—	—	—	—
Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs) Week 32	15 Participants	—	—	—	—	—	—
Part A: Number of Participants Testing Positive for Anti-drug Antibodies (ADAs) Week 39	17 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part B: Baseline to Week 16

Population: FAS, Part B: all participants randomized in Part B.

HiSCR90 was defined as at least a 90% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining fistula count

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=57 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=59 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants Who Achieved HiSCR90 at Week 16	9 Participants	15 Participants	12 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Part B: Baseline to Week 16

Population: FAS, Part B: all participants randomized in Part B.

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.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=57 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=59 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants Who Achieved HiSCR100 at Week 16	7 Participants	15 Participants	11 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Part B: Baseline to Week 16

Population: FAS, Part B: all participants randomized in Part B.

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

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=57 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=59 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants Who Achieved HiSCR50 at Week 16	22 Participants	26 Participants	26 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Part B: Day 1 through to Week 16

Population: FAS, Part B: all participants randomized in Part B.

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.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=57 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=59 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Percentage of Participants Who Experienced ≥ 1 Disease Flare Through 16 Weeks of Treatment	22.32 Percentage of participants Interval 11.7 to 32.9	18.29 Percentage of participants Interval 8.43 to 28.1	14.93 Percentage of participants Interval 5.72 to 24.1	—	—	—	—

SECONDARY outcome

Timeframe: Part B: Week 16

Population: FAS, Part B: all participants randomized in Part B, inclusive only of participants with Hurley Stage II at baseline.

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.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=34 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=35 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=36 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants With Hurley Stage II at Baseline Who Achieved AN Count of 0, 1, or 2	15 Participants	18 Participants	14 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Part B: Baseline to Week 16

Population: FAS, Part B: all participants randomized in Part B who had a 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".

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=31 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=29 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=29 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
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	4 Participants	5 Participants	9 Participants	—	—	—	—

SECONDARY outcome

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

Population: SAS: all randomized participants who received at least one dose of study drug in Part B.

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.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=57 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) n=24 Participants Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) n=26 Participants Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) n=43 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) n=53 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants With TEAEs of Special Interest	4 Participants	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	2 Participants

SECONDARY outcome

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

Population: SAS: all randomized participants who received at least one dose of study drug in Part B.

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.

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=59 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=57 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=59 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) n=24 Participants Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) n=26 Participants Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) n=43 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) n=53 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants With TEAEs Any TEAE	40 Participants	49 Participants	48 Participants	17 Participants	16 Participants	27 Participants	25 Participants
Part B: Number of Participants With TEAEs Serious TEAE	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 39 weeks

Population: ADA Analysis Set: all participants who received at lease one dose of study drug and had both baseline ADA and at least one post-dose ADA measurement in Part B.

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

Outcome measures

Outcome measures
Measure	Part A Izokibep 160 mg QW n=54 Participants Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Izokibep 160 mg QW n=54 Participants Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 31 weeks.	Part B Izokibep 160 mg Q2W n=53 Participants Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection for 30 weeks.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.
Part B: Number of Participants Testing Positive for ADAs Baseline	27 Participants	29 Participants	36 Participants	—	—	—	—
Part B: Number of Participants Testing Positive for ADAs Week 16	21 Participants	29 Participants	39 Participants	—	—	—	—
Part B: Number of Participants Testing Positive for ADAs Week 32	13 Participants	35 Participants	12 Participants	—	—	—	—
Part B: Number of Participants Testing Positive for ADAs Week 39	17 Participants	32 Participants	15 Participants	—	—	—	—

Adverse Events

Part A Izokibep 160 mg QW

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Part B Placebo QW/Q2W (Up to Week 16)

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Part B Izokibep 160 mg QW - (Up to Week 16)

Serious events: 2 serious events

Other events: 43 other events

Deaths: 0 deaths

Part B Izokibep 160 mg Q2W (Up to Week 16)

Serious events: 1 serious events

Other events: 34 other events

Deaths: 0 deaths

Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Part B Placebo/Izokibep 160 mg QW (Week 16 to 31)

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Part B: Izokibep 160 mg Q2W (Week 16 to 30)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part B: Izokibep 160 mg QW (Week 16 to 31)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A Izokibep 160 mg QW n=30 participants at risk Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Placebo QW/Q2W (Up to Week 16) n=59 participants at risk Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.	Part B Izokibep 160 mg QW - (Up to Week 16) n=57 participants at risk Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.	Part B Izokibep 160 mg Q2W (Up to Week 16) n=59 participants at risk Participants received izokibep Q2W in a blinded manor for 16 weeks.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) n=26 participants at risk Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) n=24 participants at risk Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) n=53 participants at risk Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) n=43 participants at risk Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.
Infections and infestations Epstein-Barr virus infection	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations Scrotal abscess	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations Sepsis	3.3% 1/30 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations Wound infection staphylococcal	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.2% 1/24 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	2.3% 1/43 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations Colonic abscess	3.3% 1/30 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Crohn's disease	3.3% 1/30 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Still's disease	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.2% 1/24 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.8% 1/26 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Nervous system disorders Multiple sclerosis	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	2.3% 1/43 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Part A Izokibep 160 mg QW n=30 participants at risk Participants with moderate to severe HS received open label izokibep 160 mg by SC injection QW in Part A for up to 31 weeks.	Part B Placebo QW/Q2W (Up to Week 16) n=59 participants at risk Participants with moderate to severe HS received placebo by SC injection either QW or Q2W for up to 16 weeks.	Part B Izokibep 160 mg QW - (Up to Week 16) n=57 participants at risk Participants with moderate to severe HS received izokibep 160 mg QW by SC injection for 16 weeks.	Part B Izokibep 160 mg Q2W (Up to Week 16) n=59 participants at risk Participants received izokibep Q2W in a blinded manor for 16 weeks.	Part B Placebo/Izokibep 160 mg Q2W (Week 16 to 30) n=26 participants at risk Participants received izokibep Q2W in a blinded manor for weeks 16-30.	Part B Placebo/Izokibep 160 mg QW (Week 16 to 31) n=24 participants at risk Participants received izokibep QW in a blinded manor for weeks 16-31.	Part B: Izokibep 160 mg Q2W (Week 16 to 30) n=53 participants at risk Participants with moderate to severe HS received izokibep 160 mg Q2W by SC injection during weeks 16-30.	Part B: Izokibep 160 mg QW (Week 16 to 31) n=43 participants at risk Participants with moderate to severe HS received izokibep 160 mg QW by SC injection during weeks 16-31.
General disorders Injection site erythema	40.0% 12/30 • Number of events 38 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	54.4% 31/57 • Number of events 59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	39.0% 23/59 • Number of events 44 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	26.9% 7/26 • Number of events 12 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	50.0% 12/24 • Number of events 75 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	9.4% 5/53 • Number of events 15 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	7.0% 3/43 • Number of events 17 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
General disorders Injection site pruritus	26.7% 8/30 • Number of events 23 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	28.1% 16/57 • Number of events 30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	11.9% 7/59 • Number of events 10 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	19.2% 5/26 • Number of events 5 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	20.8% 5/24 • Number of events 24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.8% 2/53 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.7% 2/43 • Number of events 4 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
General disorders Injection site swelling	20.0% 6/30 • Number of events 19 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	15.8% 9/57 • Number of events 12 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	8.5% 5/59 • Number of events 6 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	7.7% 2/26 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	12.5% 3/24 • Number of events 20 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	5.7% 3/53 • Number of events 4 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
General disorders Injection site warmth	16.7% 5/30 • Number of events 6 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
General disorders Injection site reaction	13.3% 4/30 • Number of events 13 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 7 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 7 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.9% 1/53 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
General disorders Injection site pain	10.0% 3/30 • Number of events 9 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 14 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	5.3% 3/57 • Number of events 19 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	5.1% 3/59 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	7.7% 2/26 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	12.5% 3/24 • Number of events 21 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.9% 1/53 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	2.3% 1/43 • Number of events 7 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
General disorders Injection site induration	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	7.7% 2/26 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	2.3% 1/43 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations COVID-19	6.7% 2/30 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.4% 2/59 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.4% 2/59 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.8% 1/26 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.9% 1/53 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	6.7% 2/30 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.4% 2/59 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.2% 1/24 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	6.7% 2/30 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	2.3% 1/43 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	6.7% 2/30 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.5% 2/57 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Psychiatric disorders Anxiety	6.7% 2/30 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	5.1% 3/59 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.8% 1/26 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	13.6% 8/59 • Number of events 15 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	14.0% 8/57 • Number of events 13 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	10.2% 6/59 • Number of events 6 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.2% 1/24 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	11.6% 5/43 • Number of events 7 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Vascular disorders Hypertension	6.7% 2/30 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	5.1% 3/59 • Number of events 4 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/57 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	5.3% 3/57 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.2% 1/24 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	8.5% 5/59 • Number of events 6 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	15.8% 9/57 • Number of events 10 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	8.5% 5/59 • Number of events 5 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.8% 1/26 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.9% 1/53 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	9.3% 4/43 • Number of events 4 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	10.2% 6/59 • Number of events 7 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	8.8% 5/57 • Number of events 6 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.4% 2/59 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.2% 1/24 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	7.5% 4/53 • Number of events 4 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.7% 2/43 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	6.8% 4/59 • Number of events 4 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.8% 1/26 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.9% 1/53 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.4% 2/59 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	5.3% 3/57 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/26 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/24 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.9% 1/53 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.7% 2/43 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Nervous system disorders Migraine	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/59 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.8% 1/26 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	8.3% 2/24 • Number of events 3 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/53 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/30 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	3.4% 2/59 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.8% 1/57 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.7% 1/59 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	7.7% 2/26 • Number of events 2 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	4.2% 1/24 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	1.9% 1/53 • Number of events 1 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.	0.00% 0/43 • Part A: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. Part B: Screening (Day -28) to Follow-up (Week 45), for a total of 49 weeks. SAS: all randomized participants who received at least one dose of study drug.

Additional Information

Donald Betah

Acelyrin

Phone: (805) 419-3805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per Clinical Trial Agreements, sites may not publish study results without sponsor's written consent: * sponsor has right to first publication * after first publication, site may publish if sponsor is given 60 days to review for confidential/proprietary information * if publication may impact sponsor rights (eg, a patent), sponsor may request 90-day delay * if sponsor does not publish within 12 months after study end or confirms they will not, site may publish, subject to sponsor's rights above
Publication restrictions are in place

Restriction type: OTHER