Trial Outcomes & Findings for A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis (NCT NCT04399837)

Last Updated: 2025-10-17

Results Overview

A GPP flare was defined as increase in Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score by ≥ 2 from baseline and the pustular component of GPPGA ≥ 2) up to week 48. Use of rescue medication, or investigator-prescribed Standard of Care (SoC) for GPP worsening, was considered to represent a GPP flare onset. GPPGA relied on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The GPPGA total score was calculated by taking the mean of the erythema subscore, pustules subscore and scaling/crusting subscore. The severity of each subscore was assessed using a 5 point scale score ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). The final GPPGA score is assigned as follows: * 0 , if scores for all three subscores are 0, * 1, if 0 \< mean \< 1.5, * 2, if 1.5 ≤ mean \< 2.5, * 3, if 2.5 ≤ mean \< 3.5, * 4, if mean ≥ 3.5.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

GPPGA was regularly assessed at baseline (Week 1) and up to Week 48 (at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48). Patients could come to site for flare confirmation anytime as unscheduled visit. Visit window was ±7 days.

Results posted on

2025-10-17

Participant Flow

This was a randomized multicenter, parallel group, double-blind, placebo-controlled Phase IIb trial comprising of 3 active doses compared to placebo in adolescents from 12 years to less than 18 years of age and adult patients with history of Generalized Pustular Psoriasis (GPP) and presenting (at screening and at randomization) with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 (clear or almost clear).

Subjects were screened for eligibility prior to participation and attended a specialist site which ensured that they (the subjects) 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 randomization was stratified accounting for use of systemic GPP medications at randomization (yes vs. no), and the blocking factors, region (Japan vs. non-Japan) and population (adults vs. adolescents).

Participant milestones

Participant milestones
Measure	Placebo Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Overall Study STARTED	31	31	31	30
Overall Study COMPLETED	30	27	28	26
Overall Study NOT COMPLETED	1	4	3	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Overall Study Other than listed	0	2	2	3
Overall Study Withdrawal by Subject	1	2	1	1

Baseline Characteristics

Randomized Set: This patient set includes all randomized patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=31 Participants Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Total n=123 Participants Total of all reporting groups
Age, Continuous	39.5 Years STANDARD_DEVIATION 14.0 • n=31 Participants	38.9 Years STANDARD_DEVIATION 16.5 • n=31 Participants	42.9 Years STANDARD_DEVIATION 16.7 • n=31 Participants	40.2 Years STANDARD_DEVIATION 16.4 • n=30 Participants	40.4 Years STANDARD_DEVIATION 15.8 • n=123 Participants
Sex: Female, Male Female	18 Participants n=31 Participants	20 Participants n=31 Participants	20 Participants n=31 Participants	18 Participants n=30 Participants	76 Participants n=123 Participants
Sex: Female, Male Male	13 Participants n=31 Participants	11 Participants n=31 Participants	11 Participants n=31 Participants	12 Participants n=30 Participants	47 Participants n=123 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=31 Participants	3 Participants n=31 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	7 Participants n=123 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=31 Participants	28 Participants n=31 Participants	31 Participants n=31 Participants	29 Participants n=30 Participants	116 Participants n=123 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=123 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Asian	17 Participants n=31 Participants	20 Participants n=31 Participants	21 Participants n=31 Participants	21 Participants n=30 Participants	79 Participants n=123 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Black or African American	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=123 Participants
Race (NIH/OMB) White	14 Participants n=31 Participants	11 Participants n=31 Participants	10 Participants n=31 Participants	9 Participants n=30 Participants	44 Participants n=123 Participants
Race (NIH/OMB) More than one race	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=123 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=123 Participants
Number of patients in the categories 0 or 1 of GPPGA score 0	4 Participants n=31 Participants	2 Participants n=31 Participants	8 Participants n=31 Participants	3 Participants n=30 Participants	17 Participants n=123 Participants
Number of patients in the categories 0 or 1 of GPPGA score 1	27 Participants n=31 Participants	29 Participants n=31 Participants	23 Participants n=31 Participants	27 Participants n=30 Participants	106 Participants n=123 Participants
Number of patients in the categories 0 or 1 of GPPGA pustules subscore 0	21 Participants n=31 Participants	23 Participants n=31 Participants	24 Participants n=31 Participants	20 Participants n=30 Participants	88 Participants n=123 Participants
Number of patients in the categories 0 or 1 of GPPGA pustules subscore 1	10 Participants n=31 Participants	8 Participants n=31 Participants	7 Participants n=31 Participants	10 Participants n=30 Participants	35 Participants n=123 Participants
Concomitant use of systemic GPP medication at randomization No	9 Participants n=31 Participants	6 Participants n=31 Participants	8 Participants n=31 Participants	8 Participants n=30 Participants	31 Participants n=123 Participants
Concomitant use of systemic GPP medication at randomization Yes	22 Participants n=31 Participants	25 Participants n=31 Participants	23 Participants n=31 Participants	22 Participants n=30 Participants	92 Participants n=123 Participants
Psoriasis Symptom Scale (PSS) total score at baseline	3.6 score on a scale STANDARD_DEVIATION 2.9 • n=31 Participants • Randomized Set: This patient set includes all randomized patients.	4.1 score on a scale STANDARD_DEVIATION 3.8 • n=31 Participants • Randomized Set: This patient set includes all randomized patients.	3.9 score on a scale STANDARD_DEVIATION 2.9 • n=31 Participants • Randomized Set: This patient set includes all randomized patients.	5.3 score on a scale STANDARD_DEVIATION 3.8 • n=30 Participants • Randomized Set: This patient set includes all randomized patients.	4.2 score on a scale STANDARD_DEVIATION 3.4 • n=123 Participants • Randomized Set: This patient set includes all randomized patients.
DLQI total score at baseline	7.2 score on a scale STANDARD_DEVIATION 5.6 • n=31 Participants • This patient set includes all randomized patients. Adolescents aged below 16 years were optional to the questionnaire, therefore two adolescent whose age was below 16 years were not asked to fill this questionnaire.	7.6 score on a scale STANDARD_DEVIATION 6.7 • n=30 Participants • This patient set includes all randomized patients. Adolescents aged below 16 years were optional to the questionnaire, therefore two adolescent whose age was below 16 years were not asked to fill this questionnaire.	6.6 score on a scale STANDARD_DEVIATION 5.6 • n=31 Participants • This patient set includes all randomized patients. Adolescents aged below 16 years were optional to the questionnaire, therefore two adolescent whose age was below 16 years were not asked to fill this questionnaire.	11.1 score on a scale STANDARD_DEVIATION 6.9 • n=29 Participants • This patient set includes all randomized patients. Adolescents aged below 16 years were optional to the questionnaire, therefore two adolescent whose age was below 16 years were not asked to fill this questionnaire.	8.1 score on a scale STANDARD_DEVIATION 6.4 • n=121 Participants • This patient set includes all randomized patients. Adolescents aged below 16 years were optional to the questionnaire, therefore two adolescent whose age was below 16 years were not asked to fill this questionnaire.

PRIMARY outcome

Timeframe: GPPGA was regularly assessed at baseline (Week 1) and up to Week 48 (at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48). Patients could come to site for flare confirmation anytime as unscheduled visit. Visit window was ±7 days.

Population: Randomized Set (EM-PM): This patient set includes all randomized patients. EM: Primary estimand for randomised maintenance period, where any use of rescue medication with intravenous spesolimab, or investigator-prescribed SoC for GPP worsening is considered as GPP flare. PM: Primary method for censoring, which is made at the earliest date of End of Study (EoS), Day 351 if no intercurrent event.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab IV DD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab OL SC This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48-week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Time to First Generalized Pustular Psoriasis (GPP) Flare	37.3 weeks Interval 4.0 to Insufficient number of participants with events.	NA weeks Insufficient number of participants with events.	NA weeks Insufficient number of participants with events.	NA weeks Insufficient number of participants with events.	—	—	—

SECONDARY outcome

Population: Randomized Set (EM-MI): This patient set includes all randomized patients. EM:primary estimand for randomised maintenance period, where any use of rescue medication with intravenous spesolimab, or investigator - prescribed SoC for GPP worsening is considered as GPP flare. MI: multiple imputation method using sequential logistic regression method.

Proportion of patients with at least one GPP flare up to Week 48 is reported. Proportions were rounded up to three decimal places. A GPP flare was defined as increase in Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score by ≥ 2 from baseline and the pustular component of GPPGA ≥ 2. Any use of rescue medication, or investigator-prescribed SoC for GPP worsening, prior to week 48 was considered to represent the onset of a GPP flare. Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) relied on the clinical assessment of GPP patient's skin presentation. The total score is calculated by taking the mean of the three subscores: 1) erythema; 2) pustules and 3) scaling/crusting which were assessed using a scale score 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). The final GPPGA score: 0 , if scores for all three subscores are 0, 1. if 0 \< mean \< 1.5; 2. if 1.5 ≤ mean \< 2.5; 3. if 2.5 ≤ mean \< 3.5; 4. if mean ≥ 3.5.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab IV DD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab OL SC This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48-week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Key Secondary Endpoint: The Occurrence of at Least One Generalized Pustular Psoriasis (GPP) Flare up to Week 48	0.516 proportion of patients Interval 0.348 to 0.68	0.226 proportion of patients Interval 0.114 to 0.398	0.297 proportion of patients Interval 0.181 to 0.445	0.127 proportion of patients Interval 0.05 to 0.289	—	—	—

SECONDARY outcome

Timeframe: PSS assessments were performed at: Baseline (Week 1) and up to Week 48 (at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48). Visit window was ±7 days.

Population: Randomized Set (EM-PM): This patient set includes all randomized patients. EM:primary estimand for randomised maintenance period, where any use of rescue medication with intravenous spesolimab, or investigator-prescribed SoC for GPP worsening is considered as GPP flare. PM: primary method for censoring, which is made at the earliest date of End of Study (EoS), Day 351 if no intercurrent event.

Worsening of Psoriasis Symptom Scale (PSS) was defined as a 4-point increase in total score from baseline. Intake of rescue medication, or investigator-prescribed SoC for GPP worsening, was considered as onset of a worsening. The PSS is a 4-item patient-reported outcome (PRO) instrument that was developed to assess the severity of 4 psoriasis symptoms in patients with moderate to severe psoriasis. The symptoms included are: pain, redness, itching, and burning. Current symptom severity is assessed using a 5-point scale ranging from 0 (none) to 4 (very severe). The symptom scores are added to an unweighted total score (range: 0 (no symptoms) to 16 (severe symptoms)).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab IV DD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab OL SC This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48-week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Time to First Worsening of Psoriasis Symptom Scale (PSS) up to Week 48	16.0 weeks Interval 4.0 to Insufficient number of participants with events.	NA weeks Interval 8.1 to Insufficient number of participants with events.	NA weeks Interval 8.7 to Insufficient number of participants with events.	NA weeks Interval 12.0 to Insufficient number of participants with events.	—	—	—

SECONDARY outcome

Timeframe: DLQI assessments were performed at: Baseline (Week 1) and up to Week 48 (at Week 4, 8, 12, 24, 36 and 48). Visit window was ±7 days. Time window for Week 48 was from Week 46 to Week 50.

Worsening of DLQI up to week 48 was defined as a 4-point increase in total score from baseline. Intake of rescue medication, or investigator-prescribed SoC for GPP worsening, was considered as onset of a worsening. The DLQI is a patient-administered, ten-question, quality of life questionnaire that covers six domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Response categories include "not relevant" (score of 0), "not at all" (score of 0), "a little" (score of 1), "a lot" (score of 2) and "very much" (score of 3). Question 7 is a "yes"/ "no" question where "yes" is scored as 3. DLQI total score is calculated by summing the scores of each question resulting in a range of 0 (no effect on patient's life) to 30 (extremely large effect on patient's life).

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab IV DD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab OL SC This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48-week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Time to First Worsening of Dermatology Quality of Life Index (DLQI) up to Week 48	16.0 weeks Interval 4.0 to Insufficient number of participants with events.	35.8 weeks Interval 8.1 to Insufficient number of participants with events.	49.3 weeks Interval 8.7 to 49.3	NA weeks Insufficient number of participants with events.	—	—	—

SECONDARY outcome

Population: Randomized Set (EM-MI): This patient set includes all randomized patients. EM:primary estimand for randomised maintenance period, where any use of rescue medication with intravenous spesolimab, or investigator-prescribed SoC for GPP worsening is considered as GPP flare. MI: multiple imputation method using sequential logistic regression method.

Proportion of patients with sustained remission at all visits up to Week 48. Proportions were rounded up to three decimal places. Remission was defined as a patient with a GPPGA score of 0 or 1 (clear or almost clear) at all visits up to week 48, without intake of rescue medication, or investigator-prescribed SoC for GPP worsening. GPPGA relied on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The GPPGA total score was calculated by taking the mean of the erythema subscore, pustules subscore and scaling/crusting subscore. The severity of each subscore was assessed using a 5 point scale score ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). The final GPPGA score is assigned as follows: * 0 , if scores for all three subscores are 0, * 1, if 0 \< mean \< 1.5, * 2, if 1.5 ≤ mean \< 2.5, * 3, if 2.5 ≤ mean \< 3.5, * 4, if mean ≥ 3.5.

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab IV DD This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab OL SC This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48-week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Sustained Remission	0.290 proportion of patients Interval 0.161 to 0.466	0.516 proportion of patients Interval 0.348 to 0.68	0.452 proportion of patients Interval 0.292 to 0.622	0.633 proportion of patients Interval 0.471 to 0.77	—	—	—

SECONDARY outcome

Timeframe: Up to 62 weeks (for detailed timeframe see description).

Population: Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": Safety Analysis set for flare rescue treatment period (SAF-FT). Arm "Speso OL SC": Safety Analysis set for OL maintenance treatment period (SAF-MT).

Percentage of patients with treatment emergent adverse events (TEAEs) is reported. Percentages were rounded up to one decimal places. Time Frame: Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last dose of spesolimab IV + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=32 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 Participants Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD n=22 Participants This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab IV DD n=10 Participants This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48-week treatment randomised period.	Spesolimab OL SC n=20 Participants This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48-week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
The Occurrence of Treatment Emergent Adverse Events (TEAEs)	86.7 percentage of patients	90.6 percentage of patients	93.5 percentage of patients	86.7 percentage of patients	68.2 percentage of patients	60.0 percentage of patients	75.0 percentage of patients

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Spesolimab SC Low Dose

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Spesolimab SC Medium Dose

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Spesolimab SC High Dose

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Spesolimab IV SD

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Spesolimab IV DD

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

Spesolimab OL SC

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=30 participants at risk Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=32 participants at risk Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 participants at risk Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 participants at risk Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD n=22 participants at risk This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48 week treatment randomised period.	Spesolimab IV DD n=10 participants at risk This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48 week treatment randomised period.	Spesolimab OL SC n=20 participants at risk This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48 week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Cardiac disorders Palpitations	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Oedema	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Hepatobiliary disorders Cholelithiasis	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Cellulitis	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Encephalitis viral	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Pneumonia	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Septic shock	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Skin bacterial infection	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Urinary tract infection	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	4.5% 1/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	5.0% 1/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Nervous system disorders Cerebral ischaemia	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Nervous system disorders Multiple sclerosis	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.

Other adverse events

Other adverse events
Measure	Placebo n=30 participants at risk Patients were subcutaneously (SC) injected on Day 1 of Week 1 a loading dose of solution for injection of placebo matching solution for injection of spesolimab followed by a maintenance treatment which consisted of a subcutaneous injection of solution for injection of placebo matching solution for injection of spesolimab every 4 weeks (i.e. on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 of flare (R1/D1) or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Low Dose n=32 participants at risk Patients received on Day 1 of Week 1 a loading dose which consisted of two subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300mg) and two subcutaneous injections of placebo matching solution for injection of spesolimab. The loading dose was followed by a maintenance treatment which consisted of one SC injection of 150 mg of solution for injection of spesolimab and one SC injection of placebo matching solution for injection of spesolimab every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC Medium Dose n=31 participants at risk Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 12 weeks (i.e. at Week 12, 24 and 36). To maintain the treatment blind during the trial the patients in this arm received two SC injections of placebo matching solution for injection of spesolimab at Week 4, 8, 16, 20, 28, 32, 40 and 44. The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered subcutaneously every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab SC High Dose n=30 participants at risk Patients received on Day 1 of Week 1 a loading dose which consisted of four subcutaneous (SC) injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab= 600 mg). The loading dose was followed by a maintenance treatment which consisted of two SC injections of 150 mg of solution for injection of spesolimab (total dose of spesolimab=300 mg) every 4 weeks (i.e. at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44). The patients who experienced a flare during the 48 week randomised treatment period were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare followed by OL maintenance treatment if time allowed which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).	Spesolimab IV SD n=22 participants at risk This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took a single dose (SD) of rescue treatment of 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 of flare (R1/D1) because of a GPP flare during the 48 week treatment randomised period.	Spesolimab IV DD n=10 participants at risk This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who took two doses (DD) of rescue treatment of spesolimab each 900 milligram (mg) of spesolimab administered intravenously (IV) at Day 1 and at Day 8 of flare (R1/D1 and R3/D8) because of a GPP flare during the 48 week treatment randomised period.	Spesolimab OL SC n=20 participants at risk This arm includes the patients who were randomized at study start in the arms "Placebo" or "Spesolimab SC low dose" or "Spesolimab SC medium dose" or "Spesolimab SC high dose" who experienced a flare during the 48 week randomised treatment period and were administered intravenously (IV) in an open label (OL) fashion with 900 milligram (mg) of solution for infusion of spesolimab at either Day 1 (R1/D1) of flare or at Day 1 (R1/D1) and at Day 8 (R3/D8) of flare and then followed by maintenance treatment which consisted of 300 mg of spesolimab administered SC every 12 weeks or every 4 weeks (intensified maintenance therapy).
Gastrointestinal disorders Constipation	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Gastrointestinal disorders Nausea	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	4.5% 1/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Gastrointestinal disorders Odynophagia	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Gastrointestinal disorders Vomiting	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Asthenia	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	5.0% 1/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Chest discomfort	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Injection site erythema	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	12.5% 4/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	12.9% 4/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	16.7% 5/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 2/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Injection site induration	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 2/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Injection site pain	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 2/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Injection site swelling	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.5% 2/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	5.0% 1/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
General disorders Pyrexia	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.4% 3/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.5% 2/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.1% 2/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations COVID-19	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 3/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 2/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Folliculitis	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	4.5% 1/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 2/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Influenza	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Nasopharyngitis	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.7% 3/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	5.0% 1/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Upper respiratory tract infection	13.3% 4/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.4% 3/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	19.4% 6/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	4.5% 1/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	20.0% 4/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Infections and infestations Urinary tract infection	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	13.3% 4/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.1% 2/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	15.0% 3/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Investigations Blood creatine phosphokinase increased	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	12.5% 4/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Investigations Blood trypsin increased	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	4.5% 1/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Investigations Protein urine present	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Investigations Tryptase increased	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.4% 3/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Metabolism and nutrition disorders Hypertriglyceridaemia	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	12.5% 4/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 3/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.1% 2/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Nervous system disorders Dizziness	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Nervous system disorders Headache	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.1% 2/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 2/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Psychiatric disorders Anxiety	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.5% 2/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	9.1% 2/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	4.5% 1/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Psoriasis	10.0% 3/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	12.5% 4/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	16.1% 5/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	13.3% 4/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	4.5% 1/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	10.0% 1/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Pustular psoriasis	53.3% 16/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	28.1% 9/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	29.0% 9/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	22.7% 5/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	20.0% 4/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	3.3% 1/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	6.2% 2/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.
Skin and subcutaneous tissue disorders Urticaria	6.7% 2/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.1% 1/32 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	3.2% 1/31 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/30 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/22 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	0.00% 0/10 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.	5.0% 1/20 • Placebo, Spesolimab (Speso) SC low, medium, high: From randomized study treatment start until the first use of rescue medication with IV spesolimab or until last dose + 16 weeks, up to 62 weeks. Speso IV SD and Speso IV DD: From first use of rescue medication with IV spesolimab until OL maintenance spesolimab SC or until last IV dose + 16 weeks, up to 17 weeks. Speso OL SC: From the first dose of OL spesolimab SC treatment until last dose + 16 weeks, up to 62 weeks. Arms "Placebo, Speso SC Low, medium, high":Safety Set (SAF)-This patient set included all patients who were randomized and received at least one dose of study drug. One patient who was randomized to placebo arm but received active spesolimab dose is reported under the arm "Spesolimab SC low" instead of "Placebo". Arms "Speso IV SD, Speso IV SD": SAF-FT- Safety Analysis set for flare rescue treatment period. Arm "Speso OL SC": SAF-MT- Safety Analysis set for OL maintenance treatment period.

Additional Information

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