Trial Outcomes & Findings for Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis (NCT NCT03782792)

NCT ID: NCT03782792

Last Updated: 2025-10-16

Results Overview

The Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) relies on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The investigator (or qualified site personnel) scored the erythema, pustules, and scaling of all GPP lesions from 0 to 4. The GPPGA pustulation subscore ranges from 0 to 4 where: 0 = clear; 1. = almost clear; 2. = mild: 3. = moderate; 4. = severe. A lower GPPGA pustulation subscore indicates a better outcome. A GPPGA pustulation subscore of 0 means no visible pustules. The proportion of patients who achieved a GPPGA pustulation subscore of 0 at Week 1 is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 53 participants
• Primary outcome timeframe: At Week 1.
• Results posted on: 2025-10-16

Participant Flow

This was a randomized, placebo-controlled, double-blind, parallel-group, single-dose trial with 2 treatment groups (spesolimab and placebo) to evaluate efficacy, tolerability, and safety of spesolimab (BI 655130) compared with placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.

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

Participant milestones

Measure	Placebo Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Overall Study STARTED	18	35
Overall Study Received Open Label Treatment With Spesolimab at Wk1/D8	15	12
Overall Study Received Rescue Treatment With Spesolimab After Wk1	2	4
Overall Study COMPLETED	17	32
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Placebo Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Overall Study Patient left the country	0	1
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

Baseline characteristics by cohort

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Total n=53 Participants Total of all reporting groups
Age, Continuous	42.6 Years STANDARD_DEVIATION 8.4 • n=5 Participants	43.2 Years STANDARD_DEVIATION 12.1 • n=7 Participants	43.0 Years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	35 Participants n=7 Participants	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 1.

Population: Randomized Set (RS) (via estimand EN-NRI): This patient set included all randomized patients. EN = Any assessments after death, or any use of escape medication due to disease worsening (defined as worsening of clinical status or GPP skin and/or systemic symptoms as defined by the investigator) prior to Week 1 were considered to represent a non-response. NRI = Non-response imputation for any missing data.

The Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) relies on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The investigator (or qualified site personnel) scored the erythema, pustules, and scaling of all GPP lesions from 0 to 4.

The GPPGA pustulation subscore ranges from 0 to 4 where:

0 = clear;

1. = almost clear;

2. = mild:

3. = moderate;

4. = severe. A lower GPPGA pustulation subscore indicates a better outcome. A GPPGA pustulation subscore of 0 means no visible pustules.

The proportion of patients who achieved a GPPGA pustulation subscore of 0 at Week 1 is reported.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Proportion of Patients With a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Pustulation Subscore of 0 Indicating no Visible Pustules at Week 1	0.056 Proportion of participants Interval 0.01 to 0.258	0.543 Proportion of participants Interval 0.382 to 0.695

SECONDARY outcome

Timeframe: At Week 1.

Population: Randomized Set (RS) (via estimand EN-NRI): This patient set included all randomized patients. EN =Any assessments after death, or any use of escape medication due to disease worsening (defined as worsening of clinical status or GPP skin and/or systemic symptoms as defined by the investigator) prior to Week 1 were considered to represent a non-response. NRI = Non-response imputation for any missing data.

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. A lower GPPGA score indicates a better outcome, with 0 being clear and 1 being almost clear. The proportion of patients with a GPPGA score of 0 or 1 at Week 1 is reported.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Key Secondary: Proportion of Patients With a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Score of 0 or 1 at Week 1	0.111 Proportion of participants Interval 0.031 to 0.328	0.429 Proportion of participants Interval 0.28 to 0.591

SECONDARY outcome

Timeframe: At Week 4.

Population: Randomized Set (RS) (via estimand EN-NRI): This patient set included all randomized patients. EN = Any assessments after death, or any use of escape medication before or after Day 8, open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8 were considered to represent a non-response. NRI = Non-response imputation for any missing data.

Generalized Pustular Psoriasis Area and Severity Index (GPPASI) provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs).

A higher score indicates a worse disease state, while a score of 0 indicates no disease. GPPASI 75 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 75% reduction.

Proportion of patients with GPPASI 75 at Week 4 is reported.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Proportion of Patients With a Psoriasis Area and Severity Index for Generalized Pustular Psoriasis (GPPASI) 75 at Week 4	0.111 Proportion of participants Interval 0.031 to 0.328	0.457 Proportion of participants Interval 0.305 to 0.618

SECONDARY outcome

Timeframe: Baseline and at Week 4.

Population: Randomized Set (RS) (via estimand EN-LOCF): This patient set included all randomized patients. EN = Death or any use of escape medication before or after Day 8, open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8 were considered to represent a non-response and assigned with the worst possible outcomes in rank analysis. LOCF = last observation carried forward imputation for any missing data.

The pain Visual Analogue Scale (VAS) is a participant-administered single-item scale designed to measure skin pain intensity from generalized pustular psoriasis (GPP) using a 100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from GPP is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (pain as bad as one can imagine).

Change from baseline was calculated by subtracting the VAS score at baseline from the VAS score at Week 4. A negative change indicates an improvement from baseline.

Death, any use of escape medication, OL Spesolimab at Day 8, or rescue medication with Spesolimab after Day 8, prior to observing the endpoint was considered to reflect a failure to achieve the endpoint outcome, i.e. non-response (NR).

NR is not a missing value but the worst possible outcome of the endpoint. For example, if the achieved data is (NR, NR, NR, NR, NR, NR, 2, 3, 3, 3, 5) then Q1 is NR, median is NR and Q3 is 3.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Change From Baseline in Pain Visual Analog Scale (VAS) Score at Week 4	NA Units on a scale NA = "non-response", the worst possible outcome.	-22.45 Units on a scale Interval -70.41 to NA = "non-response", the worst possible outcome.

SECONDARY outcome

Timeframe: Baseline and at Week 4.

Population: Randomized Set (RS) (via estimand EN-LOCF): This patient set included all randomized patients. EN = Any assessments after death, or any use of escape medication before or after Day 8, open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8 were considered to represent a non-response and assigned with the worst possible outcomes in rank analysis. LOCF = last observation carried forward imputation for any missing data.

PSS is a 4-item patient-reported outcome instrument that assesses the severity of psoriasis symptoms in moderate to severe psoriasis patients. The symptoms included are: pain, redness, itching, and burning. The symptom severity was assessed using a 5 point scale ranging from 0 to 4 where 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The symptom scores are added to an unweighted total score (range: 0 to 16). A lower PSS score indicates a better outcome. Change from baseline =PSS score at Week 4 - PSS score at baseline. Death, any use of escape medication, OL Spesolimab at Day 8, or rescue medication with Spesolimab after Day 8, prior to observing the endpoint was considered to reflect a failure to achieve the endpoint outcome, i.e. non-response (NR). NR is not a missing value but the worst possible outcome of the endpoint. For example, if the achieved data is (NR, NR, NR, NR, NR, NR, 2, 3, 3, 3, 5) then Q1 is NR, median is NR and Q3 is 3.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Change From Baseline in Psoriasis Symptom Scale (PSS) Score at Week 4	NA Units on a scale NA = "non-response", the worst possible outcome.	-2.0 Units on a scale Interval -9.0 to NA = "non-response", the worst possible outcome.

SECONDARY outcome

Timeframe: Baseline and at Week 4.

Population: Randomized Set (RS) (via estimand EN-LOCF): This patient set included all randomized patients. EN = Any assessments after death, or any use of escape medication before or after Day 8, open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8 were considered to represent a non-response and assigned with the worst possible outcomes in rank analysis. LOCF = last observation carried forward imputation for any missing data.

The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Each items is scored from 0 to 4. Score range is 0 (extreme fatigue)-52 (no fatigue).

Change from baseline=FACIT Fatigue score at Week 4- FACIT-Fatigue score at baseline. Death, any use of escape medication, OL Spesolimab at Day 8, or rescue medication with Spesolimab after Day 8, prior to observing the endpoint was considered to reflect a failure to achieve the endpoint outcome, i.e. non-response (NR). NR is not a missing value but the worst possible outcome of the endpoint. For example, if the achieved data is s (NR, NR, NR, NR, NR, NR, 2, 3, 3, 3, 5) then Q1 is NR, median is NR and Q3 is 3.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 4	NA Units on a scale NA = "non-response", the worst possible outcome.	3.00 Units on a scale Interval to 30.0 NA = "non-response", the worst possible outcome.

SECONDARY outcome

Timeframe: At Week 4.

Population: Randomized Set (RS) (via estimand EN-NRI): This patient set included all randomized patients. EN = Any assessments after death, or the use of escape medication (before or after Day 8), or open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8, was considered a failure to achieve the endpoint outcome (i.e. non-response). NRI = Non-response imputation for any missing data.

GPPGA relied on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The GPPGA total score is 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 scores 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. A lower GPPGA score indicates a better outcome, with 0 being clear and 1 being almost clear.

The proportion of participants with a GPPGA score of 0 or 1 at Week 4 is reported.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Proportion of Patients With a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Score of 0 or 1 at Week 4	0.111 Proportion of participants Interval 0.031 to 0.328	0.486 Proportion of participants Interval 0.33 to 0.644

SECONDARY outcome

Timeframe: At Week 4.

Population: Randomized Set (RS) (via estimand EN-NRI): This patient set included all randomized patients. EN = Any assessments after death, or the use of escape medication (before or after Day 8), or open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8, was considered a failure to achieve the endpoint outcome (i.e. non-response). NRI = Non-response imputation for any missing data.

The Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) relies on clinical assessment of the Generalized Pustular Psoriasis (GPP) patient's skin presentation. The investigator (or qualified site personnel) scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4.

The GPPGA pustulation subscore ranges from 0 to 4 where:

0 = clear;

1. = almost clear;

2. = mild:

3. = moderate;

4. = severe. A lower GPPGA pustulation subscore indicates a better outcome. The proportion of patients who achieved a GPPGA pustulation subscore of 0 at Week 1 is reported.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Proportion of Patients With a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Pustulation Sub-score of 0 Indicating no Visible Pustules at Week 4	0.111 Proportion of participants Interval 0.031 to 0.328	0.514 Proportion of participants Interval 0.356 to 0.67

SECONDARY outcome

Timeframe: At Week 4.

Population: Randomized Set (RS) (via estimand EN-NRI): This patient set included all randomized patients. EN = Any assessments after death, or the use of escape medication (before or after Day 8), or open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8, was considered a failure to achieve the endpoint outcome (i.e. non-response). NRI = Non-response imputation for any missing data.

Generalized Pustular Psoriasis Area and Severity Index (GPPASI) provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs).

A higher score indicates a worse disease state, while a score of 0 indicates no disease. GPPASI 50 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50 % reduction.

Proportion of patients with GPPASI 50 at Week 4 is reported.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Proportion of Patients With a Generalized Pustular Psoriasis Area and Severity Index (GPPASI) 50 at Week 4	0.111 Proportion of participants Interval 0.031 to 0.328	0.543 Proportion of participants Interval 0.382 to 0.695

SECONDARY outcome

Timeframe: Baseline and at Week 4.

Population: Randomized Set (RS) (via estimand EN-LOCF): This patient set included all randomized patients. EN = Any assessments after death, or any use of escape medication before or after Day 8, open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8 were considered to represent a non-response and assigned with the worst possible outcomes in rank analysis. LOCF = last observation carried forward imputation for any missing data.

GPPASI provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 (no disease) to 72 (worse disease state). It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs).

%GPPASI change from baseline=(GPPASI at Week 4-GPPASI at baseline) *100/(GPPASI at baseline).

Death, any use of escape medication, OL Spesolimab at Day 8, or rescue medication with Spesolimab after Day 8, prior to observing the endpoint was considered to reflect a failure to achieve the endpoint outcome, i.e. non-response (NR).NR is not a missing value but the worst possible outcome of the endpoint. For example, if the achieved data is (NR, NR, NR, NR, NR, NR, 2, 3, 3, 3, 5) then Q1 is NR, median is NR and Q3 is 3. Planned statistical analysis were not performed due to lack of valid data.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Percent Change in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) From Baseline at Week 4	NA Percentage change NA = "non-response", the worst possible outcome.	-60.50 Percentage change Interval -88.37 to NA = "non-response", the worst possible outcome.

SECONDARY outcome

Timeframe: At Week 1.

Population: Randomized Set (RS) (via estimand EN-NRI): This patient set included all randomized patients. EN = Any assessments after death, or the use of escape medication (before or after Day 8), or open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8, was considered a failure to achieve the endpoint outcome (i.e. non-response). NRI = Non-response imputation for any missing data.

Generalized Pustular Psoriasis Area and Severity Index (GPPASI) provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs).

A higher score indicates a worse disease state, while a score of 0 indicates no disease. GPPASI 50 is based on the percent reduction from baseline, generally summarized as a dichotomous outcome based on achieving over an 50 % reduction.

Proportion of patients with GPPASI 50 at Week 1 is reported.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Proportion of Patients With a Generalized Pustular Psoriasis Area and Severity Index (GPPASI) 50 at Week 1	0.278 Proportion of participants Interval 0.125 to 0.509	0.429 Proportion of participants Interval 0.28 to 0.591

SECONDARY outcome

Timeframe: At Week 1.

Population: Randomized Set (RS) (via estimand EN-LOCF): This patient set included all randomized patients. EN = Any assessments after death, or any use of escape medication before or after Day 8, open-label spesolimab at Day 8, or rescue medication with spesolimab after Day 8 were considered to represent a non-response and assigned with the worst possible outcomes in rank analysis. LOCF = last observation carried forward imputation for any missing data.

Generalized Pustular Psoriasis Area and Severity Index (GPPASI) provides a numeric scoring for a patient's overall Generalized Pustular Psoriasis (GPP) disease state, ranging from 0 to 72. It is a linear combination of percent of surface area of skin affected by erythema, pustules, and scaling and the severity of erythema, pustules, and scaling (desquamation) over 4 body regions (head, trunk, upper limbs and lower limbs).

A higher score indicates a worse disease state, while a score of 0 indicates no disease.

The percent change from baseline at Week 1 is calculated as:

% GPPASI change from baseline = (GPPASI at Week 1 - GPPASI at baseline) *100/GPPASI at baseline. If % GPPASI change from baseline is positive, it means the disease is becoming worse.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Percent Change in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) From Baseline at Week 1	1.02 Percentage change Interval -60.47 to 36.68	-42.80 Percentage change Interval -69.84 to 9.49

SECONDARY outcome

Timeframe: From start of treatment until Day 7, up to 7 days.

Population: Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1. Patients were analyzed according to the actual treatment received.

TEAEs were all Adverse Events (AEs) occurring between start of treatment and Day 8 (Day 8 excluded). AEs that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

The exposure-adjusted incidence rate was calculated as:

Incidence rate [1/100 patients-years] = 100 × number of patients with AE / Total AE specific time at risk [patient-years] where: Time at risk [patient-years] = (date of onset of TEAE - study drug start date + 1) /365.25

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Occurrence of Treatment Emergent Adverse Events (TEAEs) up to Week 1	6445.6 events per 100 patient-years at risk	8650.7 events per 100 patient-years at risk

SECONDARY outcome

Timeframe: From start of treatment until Day 7, up to 7 days.

Population: Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1. Patients were analyzed according to the actual treatment received.

TEAEs were all Adverse Events (AEs) occurring between start of treatment and Day 8 (Day 8 excluded). AEs that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Number of Patients With Treatment Emergent Adverse Events (TEAEs) up to Week 1	12 Participants	27 Participants

SECONDARY outcome

Timeframe: From start of treatment until end of the residual effect period (REP) but censored at any use of open label spesolimab, up to 16 weeks.

Population: Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1. Patients were analyzed according to the actual treatment received.

TEAEs were all Adverse Events (AEs) occurring between start of treatment and end of the residual effect period (REP) (16 weeks). AEs that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

The exposure-adjusted incidence rate was calculated as:

Incidence rate [1/100 patients-years] = 100 × number of patients with AE / Total AE specific time at risk [patient-years] where Time at risk where: Time at risk [patient-years] = (date of onset of TEAE - study drug start date + 1) /365.25 If, for a patient, the selected TEAE did not occur then the time at risk was censored at min

• Date of death
• For patients who did not roll over into the Open Label Extension (OLE) study: last contact date Visit14/15
• For patients who rolled over into the OLE study: the 1st dose in the OLE study
• Drug stop date + 112 days
• Date of Day 8 if OL spesolimab was given
• Date of rescue medication if spesolimab was given.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Occurrence of Treatment Emergent Adverse Events (TEAEs) Within the Treatment Phase	3083.3 events per 100 patient-years at risk	2391.0 events per 100 patient-years at risk

SECONDARY outcome

Timeframe: From start of treatment until end of the residual effect period (REP) but censored at any use of open label spesolimab, up to 16 weeks.

Population: Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1. Patients were analyzed according to the actual treatment received.

TEAEs were all Adverse Events (AEs) occurring between start of treatment and end of the residual effect period (REP) (16 weeks). AEs that started before first drug intake and deteriorated under treatment were also considered as 'treatment-emergent'.

Outcome measures

Measure	Placebo n=18 Participants Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v SD n=35 Participants Patients received intravenously (i.v.) a single dose (SD) of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.
Number of Patients With Treatment Emergent Adverse Events (TEAEs) Within the Treatment Phase	13 Participants	29 Participants

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Spesolimab 900 mg i.v. SD

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Open Label (OL) D8 Spesolimab 900 mg i.v.

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

Rescue Spesolimab 900 mg i.v.

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=18 participants at risk Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v. SD n=35 participants at risk Patients received intravenously (i.v.) a single dose of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patient worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Open Label (OL) D8 Spesolimab 900 mg i.v. n=27 participants at risk This arm included patients who in addition to the randomized treatment (either intravenously (i.v.) placebo solution to spesolimab at Day 1 or 900 milligram (mg) i.v. spesolimab at Day 1) received also Open Label Treatment with 900 mg I.V spesolimab at Week 1 (Wk1)/Day 8 (D8).	Rescue Spesolimab 900 mg i.v. n=6 participants at risk This arm included patients who in addition to the randomized treatment (either intravenously (i.v.) placebo solution to spesolimab at Day 1 or 900 milligram (mg) i.v spesolimab at Day 1) also one single rescue i.v. dose of 900 mg spesolimab between Week 1(Wk 1) to Week 12 (Wk 12).
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Infections and infestations Influenza	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Infections and infestations Urinary tract infection	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Pustular psoriasis	16.7% 3/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	11.4% 4/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	11.1% 3/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	33.3% 2/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.

Other adverse events

Measure	Placebo n=18 participants at risk Patients received intravenously (i.v.) solution for infusion containing 900 milligram (mg) of placebo to spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patients worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Spesolimab 900 mg i.v. SD n=35 participants at risk Patients received intravenously (i.v.) a single dose of solution for infusion containing 900 milligram (mg) of spesolimab on Day 1 (D1) of Week 1 (Wk1). Based on the subsequent treatment response, participants were then to be followed up for 12 to 28 weeks. If the severity and progression of the disease worsened within the first week the investigator could treat the patient with a Standard of Care (SoC) treatment of his/her choice (escape medication). If the disease condition was stable, it was recommended to wait until the primary endpoint visit (Wk1/D8) before prescribing an escape medication (SoC) since there was an option to administer open label (OL) spesolimab instead at this time. If escape medication was administered within the first week, the patient was not eligible to receive treatment with a single OL i.v. dose of 900 mg spesolimab on D8. If the condition of the patient worsened after Wk1/D8 patients were eligible to receive rescue treatment with open label spesolimab (only one single rescue i.v. dose of 900 mg spesolimab) after Wk1 to Wk 12.	Open Label (OL) D8 Spesolimab 900 mg i.v. n=27 participants at risk This arm included patients who in addition to the randomized treatment (either intravenously (i.v.) placebo solution to spesolimab at Day 1 or 900 milligram (mg) i.v. spesolimab at Day 1) received also Open Label Treatment with 900 mg I.V spesolimab at Week 1 (Wk1)/Day 8 (D8).	Rescue Spesolimab 900 mg i.v. n=6 participants at risk This arm included patients who in addition to the randomized treatment (either intravenously (i.v.) placebo solution to spesolimab at Day 1 or 900 milligram (mg) i.v spesolimab at Day 1) also one single rescue i.v. dose of 900 mg spesolimab between Week 1(Wk 1) to Week 12 (Wk 12).
Blood and lymphatic system disorders Anaemia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Blood and lymphatic system disorders Erythropenia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Cardiac disorders Palpitations	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Gastrointestinal disorders Abdominal pain	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Gastrointestinal disorders Diarrhoea	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	11.1% 3/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Gastrointestinal disorders Nausea	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	8.6% 3/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	33.3% 2/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
General disorders Asthenia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
General disorders Fatigue	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
General disorders Inflammation	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
General disorders Oedema peripheral	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
General disorders Pyrexia	22.2% 4/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	7.4% 2/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	33.3% 2/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Hepatobiliary disorders Hepatic function abnormal	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Infections and infestations Otitis externa	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	7.4% 2/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Infections and infestations Pustule	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Infections and infestations Streptococcal infection	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Infections and infestations Urinary tract infection	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Injury, poisoning and procedural complications Tendon injury	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Alanine aminotransferase increased	11.1% 2/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Aspartate aminotransferase increased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Blood lactate dehydrogenase increased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations C-reactive protein increased	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Eosinophil count increased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Eosinophil percentage increased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Haematocrit decreased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Haemoglobin decreased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations High density lipoprotein decreased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations High density lipoprotein increased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Platelet count increased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Investigations Protein total decreased	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Metabolism and nutrition disorders Decreased appetite	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Metabolism and nutrition disorders Hyperuricaemia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Joint effusion	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Joint swelling	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Oligoarthritis	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	7.4% 2/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Musculoskeletal and connective tissue disorders Tendonitis	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Nervous system disorders Dizziness	11.1% 2/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Nervous system disorders Headache	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	11.4% 4/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Nervous system disorders Paraesthesia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Nervous system disorders Syncope	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Psychiatric disorders Anxiety	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Psychiatric disorders Insomnia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Reproductive system and breast disorders Hypomenorrhoea	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Alopecia	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Dermatitis allergic	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	7.4% 2/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Pain of skin	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	7.4% 2/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	5.7% 2/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	3.7% 1/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Pustular psoriasis	22.2% 4/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	48.6% 17/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	18.5% 5/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	33.3% 2/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Skin erosion	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Skin and subcutaneous tissue disorders Urticaria	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	2.9% 1/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Vascular disorders Haemorrhage	0.00% 0/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	16.7% 1/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.
Vascular disorders Hypotension	5.6% 1/18 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/35 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/27 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.	0.00% 0/6 • Placebo and Spesolimab 900 mg i.v. SD arms: From the start of infusion of randomized medication at Day 1 (D1) of Week 1 (Wk1) until the end of its REP (16 weeks) but were censored at any use of open-label (OL) spesolimab. OL Spesolimab: From the start of OL spesolimab at Wk1/D8 until the end of its REP (16 weeks) but were censored at any use of rescue medication with spesolimab. Rescue Spesolimab: From the start of rescue medication with spesolimab until the end of its REP (16 weeks). Safety Analysis set (SAF): This patient set included all patients who were randomized and received at least one dose of study drug on Day 1.

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

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

Restriction type: OTHER