Trial Outcomes & Findings for Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa (NCT NCT05819398)

NCT ID: NCT05819398

Last Updated: 2025-11-05

Results Overview

Percent change from baseline in draining fistula/tunnel (dT) count at Week 8 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Percent change was calculated as follows: (dT count at week 8 - dT count at baseline)/ dT at baseline. Least square means and standard errors were estimated by Mixed effect model for repeated measurements (MMRM). The MMRM included fixed categorical effects of treatment at each visit, Tumor Necrosis Factor inhibitor (TNFi) status at baseline, and categorical baseline dT count at each visit. Visit were treated as the repeated measure with an unstructured covariance structure used to model the within-trial participant measurements.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

209 participants

Primary outcome timeframe

The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.

Results posted on

2025-11-05

Participant Flow

This was an international, Phase IIb/III multi-center, double-blind, placebo-controlled, randomised trial assessing the efficacy and safety of spesolimab versus placebo in patients with moderate to severe Hidradenitis suppurativa.

Subjects were screened for eligibility prior to participation and attended a specialist site which ensured that they 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. The trial was completed according to the protocol. However, part 2 was never initiated. The primary and interim analyses of part 1 (dose finding phase) didn't show signal to proceed with the confirmatory phase (part 2).

Participant milestones

Participant milestones
Measure	Placebo Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Overall Study STARTED	53	53	52	51
Overall Study COMPLETED	21	20	20	17
Overall Study NOT COMPLETED	32	33	32	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Overall Study Withdrawal by Subject	11	7	6	6
Overall Study Lost to Follow-up	0	2	0	1
Overall Study Adverse Event	1	3	4	5
Overall Study Other than listed	0	2	2	0
Overall Study Lack of Efficacy	0	1	0	0
Overall Study Study terminated by sponsor	20	18	20	22

Baseline Characteristics

Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=53 Participants Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 Participants Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 Participants Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 Participants Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Total n=209 Participants Total of all reporting groups
Age, Continuous	33.8 Years STANDARD_DEVIATION 8.8 • n=15 Participants	37.0 Years STANDARD_DEVIATION 12.1 • n=161 Participants	39.5 Years STANDARD_DEVIATION 13.9 • n=100 Participants	39.2 Years STANDARD_DEVIATION 13.5 • n=3 Participants	37.3 Years STANDARD_DEVIATION 12.3 • n=8 Participants
Sex: Female, Male Female	19 Participants n=15 Participants	22 Participants n=161 Participants	20 Participants n=100 Participants	20 Participants n=3 Participants	81 Participants n=8 Participants
Sex: Female, Male Male	34 Participants n=15 Participants	31 Participants n=161 Participants	32 Participants n=100 Participants	31 Participants n=3 Participants	128 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=15 Participants	7 Participants n=161 Participants	7 Participants n=100 Participants	7 Participants n=3 Participants	27 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=15 Participants	44 Participants n=161 Participants	44 Participants n=100 Participants	42 Participants n=3 Participants	172 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=15 Participants	2 Participants n=161 Participants	1 Participants n=100 Participants	2 Participants n=3 Participants	10 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=15 Participants	1 Participants n=161 Participants	1 Participants n=100 Participants	2 Participants n=3 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Asian	22 Participants n=15 Participants	13 Participants n=161 Participants	13 Participants n=100 Participants	15 Participants n=3 Participants	63 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=15 Participants	3 Participants n=161 Participants	1 Participants n=100 Participants	3 Participants n=3 Participants	9 Participants n=8 Participants
Race (NIH/OMB) White	23 Participants n=15 Participants	34 Participants n=161 Participants	35 Participants n=100 Participants	29 Participants n=3 Participants	121 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants	0 Participants n=161 Participants	1 Participants n=100 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=15 Participants	2 Participants n=161 Participants	1 Participants n=100 Participants	2 Participants n=3 Participants	10 Participants n=8 Participants
Number of draining fistulas/tunnels (dT)	5.2 Draining fistulas/tunnels STANDARD_DEVIATION 5.8 • n=15 Participants	5.1 Draining fistulas/tunnels STANDARD_DEVIATION 5.1 • n=161 Participants	7.0 Draining fistulas/tunnels STANDARD_DEVIATION 10.9 • n=100 Participants	6.5 Draining fistulas/tunnels STANDARD_DEVIATION 6.7 • n=3 Participants	5.9 Draining fistulas/tunnels STANDARD_DEVIATION 7.5 • n=8 Participants

PRIMARY outcome

Timeframe: The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.

Population: Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug. The use of "treatment policy" approach disregards the intercurrent event and uses the value of the variable regardless of the occurrence of the intercurrent event.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 Participants Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 Participants Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 Participants Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 8	-21.5 Percentage change Standard Error 7.7	-41.9 Percentage change Standard Error 7.8	-39.3 Percentage change Standard Error 7.9	-25.8 Percentage change Standard Error 7.9

SECONDARY outcome

Timeframe: The MMRM model incorporates dT count from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.

Percent change from baseline in draining fistula/tunnel (dT) count at Week 16 is reported. Tunnel/fistula/sinus were counted as dT only if draining. Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 Participants Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 Participants Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 Participants Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Part 1 - Percent Change From Baseline in Draining Fistula/Tunnel (dT) Count at Week 16	-14.0 Percentage change Standard Error 10.6	-23.5 Percentage change Standard Error 10.7	-36.2 Percentage change Standard Error 10.8	-22.7 Percentage change Standard Error 11.2

SECONDARY outcome

Timeframe: The MMRM model incorporates IHS4 value from baseline (Week 0), Week 2, Week 4, Week 6 and Week 8. The data represent the Least Squares Means at Week 8.

IHS4 is a validated, clinical scoring system for dynamic assessment of HS severity. The score was calculated as: (number of nodules x1) + (number of abscesses x2) + (number of draining tunnels \[fistulae/sinuses\] x4). The minimum is 0, the maximum depends on the count of nodules, abscesses, and draining tunnels. Scores 0-3 indicate mild HS, 4-10 moderate HS, ≥11 severe HS. Absolute change from baseline was calculated as follows: (IHS4 value at visit timepoints) - (IHS4 value at baseline). Least square means and standard errors were estimated by MMRM, which included fixed categorical effects of treatment at each visit, TNFi status at baseline, categorical baseline dT count and fixed continuous effect of baseline of outcome measures at each visit. Visit was treated as repeated measure with an unstructured covariance matrix for the within trial participant variability and all visits with planned measurements of the outcome variable as well as all dose groups were included in the model.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 Participants Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 Participants Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 Participants Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 8	-13.5 Units on a scale Standard Error 2.5	-11.1 Units on a scale Standard Error 2.5	-14.1 Units on a scale Standard Error 2.5	-10.5 Units on a scale Standard Error 2.5

SECONDARY outcome

Timeframe: The MMRM model incorporates IHS4 from baseline (Week 0), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14 and Week 16. The data represent the Least Squares Means at Week 16.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 Participants Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 Participants Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 Participants Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Part 1 - Absolute Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) Value at Week 16	-11.8 Units on a scale Standard Error 3.8	-7.2 Units on a scale Standard Error 3.9	-17.0 Units on a scale Standard Error 3.9	-4.2 Units on a scale Standard Error 4.0

SECONDARY outcome

Timeframe: From first drug administration until end of exposure, plus residual effect period, up to approximately 68 weeks.

Population: Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.

The occurrence of treatment emergent adverse events (TEAEs) is reported as the number of patients with TEAEs.

Outcome measures

Outcome measures
Measure	Placebo n=53 Participants Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 Participants Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 Participants Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 Participants Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs)	44 Participants	47 Participants	51 Participants	47 Participants

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 29 other events

Deaths: 0 deaths

Spesolimab following placebo

Serious events: 7 serious events

Other events: 32 other events

Deaths: 0 deaths

Spesolimab low dose group

Serious events: 3 serious events

Other events: 39 other events

Deaths: 0 deaths

Spesolimab medium dose group

Serious events: 8 serious events

Other events: 38 other events

Deaths: 0 deaths

Spesolimab high dose group

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=53 participants at risk Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab following placebo n=50 participants at risk Patients in the placebo group switched from Week 16 until the end of treatment (Week 48) to the same subcutaneous injection (s.c.) dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 participants at risk Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 participants at risk Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 participants at risk Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Blood and lymphatic system disorders Anaemia	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Abdominal abscess	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Pneumonia	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Severe fever with thrombocytopenia syndrome	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Urinary tract infection	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Cardiac disorders Cardiac failure	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Cardiac disorders Sinoatrial block	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Hepatobiliary disorders Bile duct stone	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Abscess limb	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Sepsis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Skin infection	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Subcutaneous abscess	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Cardiac disorders Atrial tachycardia	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Cardiac disorders Heart failure with preserved ejection fraction	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Hepatobiliary disorders Biliary colic	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Latent tuberculosis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Scrotal abscess	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Investigations Hepatic enzyme increased	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Metabolism and nutrition disorders Obesity	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Psychiatric disorders Suicidal ideation	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Placebo n=53 participants at risk Patients with moderate to severe Hidradenitis suppurativa (HS) were administered an initial weekly dose of placebo via intravenous infusion (i.v.) (Week 0 to Week 3). Afterwards, patients were administered a subcutaneous injection (s.c.) dose of placebo once a week for 4 weeks (Week 4 to Week 7), and once every 2 weeks for the following 7 weeks (Week 8 to Week 14). From Week 16 until the end of treatment (Week 48), patients were switched to the same s.c. dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab following placebo n=50 participants at risk Patients in the placebo group switched from Week 16 until the end of treatment (Week 48) to the same subcutaneous injection (s.c.) dose of spesolimab administered to patients in the medium and high dose groups (starting with 3 loading s.c. doses of spesolimab every week and then maintenance s.c. dose of spesolimab every 2 weeks).	Spesolimab low dose group n=53 participants at risk Patients with moderate to severe HS were administered an initial weekly low dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48). From Week 16, if patients had inadequate clinical response defined as 25% increase in the ANdT count compared to baseline, the dose could be increased every two weeks to a pre-determined concentration.	Spesolimab medium dose group n=52 participants at risk Patients with moderate to severe HS were administered an initial weekly medium dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).	Spesolimab high dose group n=51 participants at risk Patients with moderate to severe HS were administered an initial weekly high dose of spesolimab via i.v. (Week 0 to Week 3). Afterwards, patients were administered a lower weekly s.c. dose of spesolimab for 4 weeks (Week 4 to Week 7). Patients were then administered a maintenance s.c. dose of spesolimab every two weeks until the end of the treatment (Week 8 to Week 48).
Gastrointestinal disorders Diarrhoea	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	7.8% 4/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Nausea	7.5% 4/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Chest pain	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Fatigue	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	9.8% 5/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Injection site pain	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Injection site pruritus	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.9% 3/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Injection site reaction	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	10.0% 5/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	9.4% 5/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.9% 2/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Pyrexia	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	10.0% 5/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	7.8% 4/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Nasopharyngitis	7.5% 4/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	17.3% 9/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	13.7% 7/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	10.0% 5/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	17.0% 9/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	21.2% 11/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	13.7% 7/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Nervous system disorders Dizziness	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Nervous system disorders Headache	17.0% 9/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	11.3% 6/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	11.5% 6/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	9.8% 5/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hidradenitis	17.0% 9/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	26.0% 13/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	35.8% 19/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	19.2% 10/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	19.6% 10/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	9.4% 5/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Gastrointestinal disorders Constipation	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	7.8% 4/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Influenza like illness	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Injection site bruising	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Injection site erythema	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.9% 3/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Injection site swelling	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
General disorders Pain	7.5% 4/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	9.8% 5/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations COVID-19	3.8% 2/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	8.0% 4/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	7.5% 4/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Folliculitis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Influenza	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	7.5% 4/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Rhinitis	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.9% 2/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	4.0% 2/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.9% 2/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Vascular disorders Hypertension	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.8% 2/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	3.9% 2/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Oral herpes	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.8% 3/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Sinusitis	0.00% 0/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	6.0% 3/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Infections and infestations Urinary tract infection	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	2.0% 1/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.7% 3/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	7.8% 4/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	0.00% 0/50 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/53 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	1.9% 1/52 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.	5.9% 3/51 • From first drug administration until end of exposure (date of last administration - date of first administration +1 day + dosing interval [7 days if last dose was on Week 0-7 or 16-17; 14 days if last dose was on Week 8-14, 18-48]), plus residual effect period, up to approximately 68 weeks. Safety Analysis Set (SAF): all subjects who were randomized and received at least one dose of study drug.

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