Trial Outcomes & Findings for Hidradenitis Suppurativa Study of Izokibep (NCT NCT05905783)

NCT ID: NCT05905783

Last Updated: 2025-10-15

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 258 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2025-10-15

Participant Flow

A total of 258 participants were enrolled in Canada, France, Germany, Japan, Poland, Spain and the United States from June 2023 to January 2025. Participants were randomized to receive izokibep or placebo once weekly (QW) until Week 15 (Period 1). Then, all participants received izokibep QW from Week 16 until Week 51 (Period 2). The Sponsor decided to terminate the study early after all participants completed (or discontinued) treatment at Week 32.

Participant milestones

Measure	Placebo-Izokibep 160 mg QW Participants received placebo as a subcutaneous (SC) injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW Participants received izokibep as a SC injection QW from Day 1 to Week 51.
Overall Study STARTED	129	129
Overall Study Completed Period 1	109	103
Overall Study COMPLETED	19	9
Overall Study NOT COMPLETED	110	120

Reasons for withdrawal

Measure	Placebo-Izokibep 160 mg QW Participants received placebo as a subcutaneous (SC) injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW Participants received izokibep as a SC injection QW from Day 1 to Week 51.
Overall Study Lost to Follow-up	12	18
Overall Study Withdrawal by Subject	29	37
Overall Study Decision by sponsor	69	65

Baseline Characteristics

Hidradenitis Suppurativa Study of Izokibep

Baseline characteristics by cohort

Measure	Placebo-Izokibep 160 mg QW n=129 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=129 Participants Participants received izokibep QW from Day 1 to Week 51.	Total n=258 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=5 Participants	127 Participants n=7 Participants	252 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 12.85 • n=5 Participants	37.1 years STANDARD_DEVIATION 11.89 • n=7 Participants	37.3 years STANDARD_DEVIATION 12.35 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	89 Participants n=7 Participants	178 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants	115 Participants n=7 Participants	223 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	28 Participants n=5 Participants	21 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized White	90 Participants n=5 Participants	91 Participants n=7 Participants	181 Participants n=5 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all participants who were randomized.

The percentage of participants achieving HiSCR75 was defined as meeting all 3 criteria below:

• ([abscess and inflammatory nodule (AN) count at baseline - AN count at current visit] / AN count at baseline) × 100% ≥ 75%
• Abscess count at baseline ≥ abscess count at the current visit
• Draining fistula count at baseline ≥ draining fistula count at the current visit.

HiSCR75 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=129 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=129 Participants Participants received izokibep QW from Day 1 to Week 51.
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 12	20.3 percentage of participants Interval 13.1 to 27.6	32.6 percentage of participants Interval 24.3 to 40.9

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all participants who were randomized.

The percentage of participants achieving HiSCR90 was defined as meeting all 3 criteria below:

• ([AN count at baseline - AN count at current visit] / AN count at baseline) × 100% ≥ 90%
• Abscess count at baseline ≥ abscess count at the current visit
• Draining fistula count at baseline ≥ draining fistula count at the current visit.

HiSCR90 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=129 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=129 Participants Participants received izokibep QW from Day 1 to Week 51.
Percentage of Participants Achieving HiSCR90 at Week 12	9.2 percentage of participants Interval 3.8 to 14.5	24.3 percentage of participants Interval 16.7 to 31.9

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all participants who were randomized.

The percentage of participants achieving HiSCR100 was defined as meeting all 3 criteria below:

• ([AN count at baseline - AN count at current visit] / AN count at baseline) × 100% = 100%
• Abscess count at baseline ≥ abscess count at the current visit
• Draining fistula count at baseline ≥ draining fistula count at the current visit.

HiSCR100 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=129 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=129 Participants Participants received izokibep QW from Day 1 to Week 51.
Percentage of Participants Achieving HiSCR100 at Week 12	7.3 percentage of participants Interval 2.5 to 12.2	21.4 percentage of participants Interval 14.2 to 28.7

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all participants who were randomized.

The percentage of participants achieving HiSCR50 was defined as meeting all 3 criteria below:

• [(AN count at baseline - AN count at current visit) / AN count at baseline] × 100% ≥ 50%
• Abscess count at baseline ≥ abscess count at the current visit
• Draining fistula count at baseline ≥ draining fistula count at the current visit.

HiSCR50 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=129 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=129 Participants Participants received izokibep QW from Day 1 to Week 51.
Percentage of Participants Achieving HiSCR50 at Week 12	36.5 percentage of participants Interval 27.8 to 45.2	47.9 percentage of participants Interval 39.0 to 56.8

SECONDARY outcome

Timeframe: Up to Week 12

Population: Full Analysis Set: all participants who were randomized.

HS flares were defined as ≥ 25% increase in AN count with a minimum increase of 2 AN relative to baseline, i.e. participants must meet all the following criteria:

• (AN count at current visit- AN count at baseline) / AN count at baseline ×100% ≥ 25%
• AN count at current visit- AN count at baseline ≥ 2.

Participants who received antibiotic therapy that could affect HS were imputed as non-response (NRI). Other participants with missing data were imputed with multiple imputation.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=129 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=129 Participants Participants received izokibep QW from Day 1 to Week 51.
Percentage of Participants Who Experienced One or More (≥ 1) Disease Flare at Week 12	31.1 percentage of participants Interval 22.9 to 39.3	28.3 percentage of participants Interval 20.5 to 36.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set: all participants who were randomized. Only participants with a result at the timepoint are included.

DLQI included 10 items arranged in 6 categories: symptoms and feelings, daily activity, leisure, work or study, interpersonal relationships, and treatment. The total score could range from 0 (no impact to life quality) to 30 (maximum impact).

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=112 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=102 Participants Participants received izokibep QW from Day 1 to Week 51.
Change From Baseline in Dermatology Life Quality Index (DLQI)	-2.71 Score on scale Standard Error 0.519	-4.87 Score on scale Standard Error 0.536

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all participants who were randomized. Participants with Hurley Stage II at baseline were included.

Calculated as observed values of 0, 1, or 2 for AN count (abscess count + inflammatory nodule count).

AN count of 0, 1, or 2 was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=82 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=78 Participants Participants received izokibep QW from Day 1 to Week 51.
Percentage of Participants With Baseline Hurley Stage II Who Achieved AN Count of 0, 1, or 2 at Week 12	25.0 percentage of participants Interval 15.2 to 34.8	49.5 percentage of participants Interval 38.1 to 61.0

SECONDARY outcome

Timeframe: Week 12

Population: Full Analysis Set: all participants who were randomized. Participants with baseline NRS ≥ 4 were included.

NRS in Patient Global Assessment of Skin Pain ranged from 0 (no skin pain) to 10 (skin pain bad as you can imagine). The skin pain score at each visit was calculated using average of daily scores among the 7 days up to and including the day of visit, with a minimum of 4 days (consecutive or non-consecutive) with scores required.

Reduction in NRS was evaluated using nonresponse imputation (NRI) and multiple imputation (MI) methods.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=79 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=73 Participants Participants received izokibep QW from Day 1 to Week 51.
Percentage of Participants With Baseline NRS ≥ 4 Achieving at Least 3-point Reduction at Week 12 in Numeric Rating Scale (NRS) Patient Global Assessment of Skin Pain at Its Worst	17.2 Percentage of participants Interval 8.4 to 25.9	33.5 Percentage of participants Interval 22.1 to 44.8

SECONDARY outcome

Timeframe: Up to Week 16

Population: Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.

An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

The following events of special interest were monitored in this study: candida infection; inflammatory bowel disease (IBD); suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events; tuberculosis; infections; cytopenias and systemic hypersensitivity reactions.

Clinically significant changes in vital signs and laboratory tests recorded after treatment administration were documented as TEAEs.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=129 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=129 Participants Participants received izokibep QW from Day 1 to Week 51.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1 TEAEs	76 Participants	107 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1 SAEs	5 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious AEs (SAEs) and Adverse Event of Special Interest (AESIs) in Period 1 AESIs	3 Participants	0 Participants

SECONDARY outcome

Timeframe: From Week 16 to follow-up, Week 59

Population: Safety Analysis Set Period 2: All participants who were randomized and received at least 1 administration of study treatment in Period 2 of the Study.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.

An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

The following events of special interest were monitored in this study: candida infection; IBD; suicidal ideation; malignancies; major adverse cardiovascular and cerebrovascular events; tuberculosis; infections; cytopenias and systemic hypersensitivity reactions.

Clinically significant changes in vital signs and laboratory tests recorded after treatment administration were documented as TEAEs.

Outcome measures

Measure	Placebo-Izokibep 160 mg QW n=109 Participants Participants received placebo as a SC injection QW from Day 1 to Week 15, then izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW n=100 Participants Participants received izokibep QW from Day 1 to Week 51.
Number of Participants With TEAEs, SAEs and AESIs in Period 2 TEAEs	87 Participants	66 Participants
Number of Participants With TEAEs, SAEs and AESIs in Period 2 SAEs	3 Participants	4 Participants
Number of Participants With TEAEs, SAEs and AESIs in Period 2 AESIs	5 Participants	1 Participants

Adverse Events

Placebo QW - Izokibep 160 mg QW: Period 1

Serious events: 5 serious events

Other events: 35 other events

Deaths: 0 deaths

Izokibep 160 mg QW: Period 1

Serious events: 1 serious events

Other events: 93 other events

Deaths: 0 deaths

Placebo QW - Izokibep 160 mg QW: Period 2

Serious events: 3 serious events

Other events: 69 other events

Deaths: 0 deaths

Izokibep 160 mg QW: Period 2

Serious events: 4 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo QW - Izokibep 160 mg QW: Period 1 n=129 participants at risk Participants received placebo as a SC injection QW from Day 1 to Week 15.	Izokibep 160 mg QW: Period 1 n=129 participants at risk Participants received izokibep QW from Day 1 to Week 15.	Placebo QW - Izokibep 160 mg QW: Period 2 n=109 participants at risk Participants received izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW: Period 2 n=100 participants at risk Participants received izokibep QW from Week 16 to Week 51.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	1.0% 1/100 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Injury, poisoning and procedural complications Pelvic fracture	0.78% 1/129 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Injury, poisoning and procedural complications Post procedural complication	0.78% 1/129 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Gastrointestinal disorders Abdominal pain lower	0.78% 1/129 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Investigations Hepatic enzyme increased	0.78% 1/129 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.92% 1/109 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Renal and urinary disorders Urinary retention	0.78% 1/129 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Skin and subcutaneous tissue disorders Hidradenitis	0.78% 1/129 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	1.0% 1/100 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Vascular disorders Vasculitis	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.78% 1/129 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	1.0% 1/100 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	1.0% 1/100 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.92% 1/109 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Eye disorders Eye disorder	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	1.0% 1/100 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Infections and infestations Cellulitis	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/129 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.92% 1/109 • Number of events 1 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.

Other adverse events

Measure	Placebo QW - Izokibep 160 mg QW: Period 1 n=129 participants at risk Participants received placebo as a SC injection QW from Day 1 to Week 15.	Izokibep 160 mg QW: Period 1 n=129 participants at risk Participants received izokibep QW from Day 1 to Week 15.	Placebo QW - Izokibep 160 mg QW: Period 2 n=109 participants at risk Participants received izokibep as a SC injection QW from Week 16 to Week 51.	Izokibep 160 mg QW: Period 2 n=100 participants at risk Participants received izokibep QW from Week 16 to Week 51.
General disorders Injection site reaction	7.8% 10/129 • Number of events 16 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	66.7% 86/129 • Number of events 380 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	60.6% 66/109 • Number of events 328 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	34.0% 34/100 • Number of events 186 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
General disorders Fatigue	2.3% 3/129 • Number of events 3 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	5.4% 7/129 • Number of events 12 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	2.0% 2/100 • Number of events 2 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Infections and infestations Nasopharyngitis	7.0% 9/129 • Number of events 12 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	8.5% 11/129 • Number of events 11 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	4.6% 5/109 • Number of events 5 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	8.0% 8/100 • Number of events 9 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Infections and infestations Upper respiratory tract infection	3.9% 5/129 • Number of events 6 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	5.4% 7/129 • Number of events 7 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	4.6% 5/109 • Number of events 5 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	4.0% 4/100 • Number of events 5 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Nervous system disorders Headache	12.4% 16/129 • Number of events 37 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	10.9% 14/129 • Number of events 26 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	1.8% 2/109 • Number of events 2 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	5.0% 5/100 • Number of events 6 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.
Gastrointestinal disorders Diarrhoea	1.6% 2/129 • Number of events 3 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	5.4% 7/129 • Number of events 7 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/109 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.	0.00% 0/100 • From Screening (Day -28) to Follow-up (Week 59), up to approximately 63 weeks An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Safety Analysis Set: All participants who were randomized and received at least 1 administration of study treatment.

Additional Information

Clinical Trials Information Desk

Acelyrin Inc.

Phone: (650) 231 6625

Email: info@alumis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place