Trial Outcomes & Findings for A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab (NCT NCT06241573)

Last Updated: 2026-06-17

Results Overview

The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs. TEAEs were defined as all adverse events occurring between start of treatment in the extension trial and the end of its residual effect period. Adverse events that start before first drug intake in the extension trial and deteriorate under treatment during the extension trial were also considered as 'treatment-emergent'.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

39 participants

Primary outcome timeframe

From first drug administration, up to 16 weeks after last administration, up to 39 weeks.

Results posted on

2026-06-17

Participant Flow

This was a randomised, placebo-controlled, double-blind, 92-week extension trial to investigate the long-term safety of spesolimab in participants with hidradenitis suppurativa who had completed their treatment in Part 1 of trial 1368-0098.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	Spesolimab Low Dose Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose With Prior Placebo Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Overall Study STARTED	5	21	13
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	5	21	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Spesolimab Low Dose Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose With Prior Placebo Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Overall Study Withdrawal by Subject	0	0	1
Overall Study Other	0	1	0
Overall Study Study Terminated by Sponsor	5	20	12

Baseline Characteristics

A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spesolimab Low Dose n=5 Participants Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose n=21 Participants Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose With Prior Placebo n=13 Participants Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Total n=39 Participants Total of all reporting groups
Age, Continuous	42.2 Years STANDARD_DEVIATION 5.8 • n=9 Participants	45.0 Years STANDARD_DEVIATION 12.0 • n=27 Participants	33.8 Years STANDARD_DEVIATION 8.1 • n=267 Participants	40.9 Years STANDARD_DEVIATION 11.3 • n=265 Participants
Sex: Female, Male Female	2 Participants n=9 Participants	10 Participants n=27 Participants	4 Participants n=267 Participants	16 Participants n=265 Participants
Sex: Female, Male Male	3 Participants n=9 Participants	11 Participants n=27 Participants	9 Participants n=267 Participants	23 Participants n=265 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants	2 Participants n=27 Participants	3 Participants n=267 Participants	6 Participants n=265 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=9 Participants	19 Participants n=27 Participants	8 Participants n=267 Participants	31 Participants n=265 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	2 Participants n=267 Participants	2 Participants n=265 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Asian	3 Participants n=9 Participants	6 Participants n=27 Participants	6 Participants n=267 Participants	15 Participants n=265 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	2 Participants n=27 Participants	0 Participants n=267 Participants	2 Participants n=265 Participants
Race (NIH/OMB) White	2 Participants n=9 Participants	13 Participants n=27 Participants	5 Participants n=267 Participants	20 Participants n=265 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	2 Participants n=267 Participants	2 Participants n=265 Participants

PRIMARY outcome

Timeframe: From first drug administration, up to 16 weeks after last administration, up to 39 weeks.

Population: Treated Set (TS): all participants who have received at least 1 dose of trial treatment.

Outcome measures

Outcome measures
Measure	Spesolimab Low Dose n=5 Participants Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose n=21 Participants Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose With Prior Placebo n=13 Participants Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Occurrence of Treatment Emergent Adverse Events (TEAE) up to the End of Maintenance Treatment Period	3 Participants	6 Participants	5 Participants

Adverse Events

Spesolimab Low Dose

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Spesolimab High Dose

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Spesolimab High Dose With Prior Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spesolimab Low Dose n=5 participants at risk Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose n=21 participants at risk Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose With Prior Placebo n=13 participants at risk Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Infections and infestations Sweat gland infection	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.

Other adverse events

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Spesolimab Low Dose n=5 participants at risk Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. To keep the study blinded, participants were additionally administered placebo to match the volume administered to the participants in the high dose group. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose n=21 participants at risk Participants with hidradenitis suppurativa who completed their treatment with spesolimab in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.	Spesolimab High Dose With Prior Placebo n=13 participants at risk Participants with hidradenitis suppurativa who completed their treatment with placebo in Part 1 of trial 1368-0098 and who met the eligibility criteria for this extension trial. Participants continued on the same dosing regimen that they had in the parent trial. Spesolimab was administered every 2 weeks with a subcutaneous injection. Patients were planned to be treated for 76 weeks, followed by a 16-week safety follow-up period.
Infections and infestations Nasopharyngitis	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	15.4% 2/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Infections and infestations Rhinitis	20.0% 1/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Infections and infestations Tinea cruris	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Investigations Interferon gamma release assay positive	20.0% 1/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Metabolism and nutrition disorders Gout	20.0% 1/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Nervous system disorders Headache	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Renal and urinary disorders Microalbuminuria	20.0% 1/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	4.8% 1/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	15.4% 2/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
General disorders Inflammation	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
General disorders Injection site bruising	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
General disorders Injection site pain	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/5 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	0.00% 0/21 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.	7.7% 1/13 • Adverse events: from first drug administration, up to 16 weeks after last administration, up to 39 weeks. All-cause mortality: from first drug administration until end of study, up to 40 weeks. Treated Set (TS): all participants who have received at least 1 dose of trial treatment.