Trial Outcomes & Findings for A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated (NCT NCT03822832)

Last Updated: 2025-10-17

Results Overview

Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Results posted on

2025-10-17

Participant Flow

This was a phase IIa multicentre, randomized, double-blind, placebocontrolled, study to evaluate the safety, tolerability and efficacy of treatment with BI 655130 in adult patients with moderate to severe atopic dermatitis.

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

Participant milestones

Participant milestones
Measure	Placebo Intravenous Every 4 Weeks Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Period 1 - Double Blind Period STARTED	18	33
Period 1 - Double Blind Period COMPLETED	8	22
Period 1 - Double Blind Period NOT COMPLETED	10	11
Re-allocation STARTED	8	22
Re-allocation COMPLETED	6	16
Re-allocation NOT COMPLETED	2	6
Period 2 - Open Label Period STARTED	6	16
Period 2 - Open Label Period COMPLETED	5	13
Period 2 - Open Label Period NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Intravenous Every 4 Weeks Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Period 1 - Double Blind Period Withdrawal by Subject	3	3
Period 1 - Double Blind Period Lost to Follow-up	1	1
Period 1 - Double Blind Period Protocol Violation	1	1
Period 1 - Double Blind Period Lack of Efficacy	2	1
Period 1 - Double Blind Period Adverse Event	3	5
Re-allocation Not re-allocated to open label period	2	6
Period 2 - Open Label Period Lost to Follow-up	1	0
Period 2 - Open Label Period Adverse Event	0	3

Baseline Characteristics

A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Intravenous Every 4 Weeks n=18 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=33 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Total n=51 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 12.4 • n=99 Participants	43.2 years STANDARD_DEVIATION 15.9 • n=107 Participants	39.4 years STANDARD_DEVIATION 15.5 • n=206 Participants
Sex: Female, Male Female	11 Participants n=99 Participants	15 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	7 Participants n=99 Participants	18 Participants n=107 Participants	25 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	6 Participants n=107 Participants	9 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants	27 Participants n=107 Participants	42 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	6 Participants n=99 Participants	10 Participants n=107 Participants	16 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) White	7 Participants n=99 Participants	17 Participants n=107 Participants	24 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Eczema Area and Severity Index (EASI) Score	26.43 Score on a scale STANDARD_DEVIATION 8.60 • n=99 Participants	26.53 Score on a scale STANDARD_DEVIATION 10.07 • n=107 Participants	26.50 Score on a scale STANDARD_DEVIATION 9.49 • n=206 Participants
SCORing of Atopic Dermatitis (SCORAD)	62.82 Score on a scale STANDARD_DEVIATION 14.13 • n=99 Participants	60.09 Score on a scale STANDARD_DEVIATION 10.36 • n=107 Participants	61.06 Score on a scale STANDARD_DEVIATION 11.76 • n=206 Participants
Investigator's Global Assessment (IGA) score	3.4 Score on a scale STANDARD_DEVIATION 0.5 • n=99 Participants	3.2 Score on a scale STANDARD_DEVIATION 0.4 • n=107 Participants	3.3 Score on a scale STANDARD_DEVIATION 0.5 • n=206 Participants

PRIMARY outcome

Timeframe: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=12 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=28 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 16	-12.3 Percent change Standard Error 14.3	-37.9 Percent change Standard Error 9.8

SECONDARY outcome

Timeframe: Up to 28 weeks, see endpoint description for more details.

Population: Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Re-allocation treatment period: This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).

Number of patients with drug related Adverse Events (AEs) reported separately in both for the double blind period as well as the re-allocation treatment period. Double blind period: Baseline (week 1) to the last study drug administration date (week 12) + Residual effects period (REP, 16 weeks). For patients who initiated the re-allocation treatment period the REP was shortened to the date of first re-allocation treatment period treatment administration. Up to a total time frame of 28 weeks. Re-allocation treatment period: Week 1 of re-allocation treatment period to the last study drug administration date (week 12 of re-allocation treatment period) + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=18 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=33 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Number of Patients With Drug Related Adverse Events (AEs) Double blind treatment period	6 Participants	4 Participants
Number of Patients With Drug Related Adverse Events (AEs) Re-allocation treatment period	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

Absolute change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=16 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=29 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4	-7.0 Change in score on a scale Standard Error 3.0	-6.3 Change in score on a scale Standard Error 2.2

SECONDARY outcome

Timeframe: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

Percentage change from baseline in the Eczema Area and Severity Index (EASI) Score at Week 4. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe. Restricted maximum likelihood(REML)-based Mixed Model Repeated Measures (MMRM) including fixed, categorical effects of treatment, visit, and Asian/Non-Asian (yes/no) as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=16 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=29 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Week 4	-21.6 Percent change Standard Error 11.3	-23.8 Percent change Standard Error 8.3

SECONDARY outcome

Timeframe: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

Proportion of patients with a 50% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=18 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=33 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16 Week 4	0.333 Proportion of patients	0.303 Proportion of patients
Proportion of Patients With a 50% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI50) at Week 4 and 16 Week 16	0.056 Proportion of patients	0.303 Proportion of patients

SECONDARY outcome

Timeframe: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

Proportion of patients with a 75% improvement from baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16. The EASI score assesses the extent of disease at four body sites and measures four clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale of zero to three. The EASI score confers a maximum of 72 and evaluates two dimensions of Atopic Dermatitis (AD): disease extent and clinical signs. The suggested severity strata for the EASI are as follows: 0 = clear; 0.1-1.0 = almost clear; 1.1-7.0 = mild; 7.1-21.0 = moderate; 21.1-50.0 = severe; 50.1-72.0 = very severe.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=18 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=33 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16 Week 4	0.111 Proportion of patients	0.091 Proportion of patients
Proportion of Patients With a 75% Improvement From Baseline in Eczema Area and Severity Index (EASI)(EASI75) at Week 4 and 16 Week 16	0.056 Proportion of patients	0.152 Proportion of patients

SECONDARY outcome

Timeframe: Baseline (day 1) and Week 4 (day 29 ±3 days), up to 32 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

SCORing of Atopic Dermatitis (SCORAD). Extent (A): rule of 9 was used to calculate body surface area affected by AD. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed from none=0to severe=3. Severity scores summed to B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale from 0 to 10, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7\*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. REML-based MMRM including fixed, categorical effects of treatment, visit, and Asian/Non-Asian as well as the treatment-by-visit interaction, and continuous, fixed covariates of baseline endpoint and baseline-by-visit interaction. Unstructured covariance matrix was used.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=16 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=29 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 4	-13.3 Change in score on a scale Standard Error 7.0	-13.2 Change in score on a scale Standard Error 5.2

SECONDARY outcome

Timeframe: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=12 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=28 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Change From Baseline in SCORing of Atopic Dermatitis (SCORAD) at Week 16	-10.7 Change in score on a scale Standard Error 10.0	-25.5 Change in score on a scale Standard Error 6.8

SECONDARY outcome

Timeframe: Baseline (day 1) and Week 16 (day 113 ±3 days), up to 116 days.

Population: Full Analysis Set (FAS): All participants who were randomised, received at least one dose during the trial, and had a baseline measurement for the primary endpoint.

Number of patients achieving at least a 2-grade reduction from baseline to clear (0) or almost clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16. IGA score allows investigators to assess the overall disease severity at one given time point. It is a 5-point scale with: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. The overall IGA score includes the assessment of erythema, induration/papulation, lichenification, and oozing/crusting. For the first three sections the following scale will be used: "None", "Barely Perceptible" ("Minimal" for lichenification), "Slight but Definite", "Clearly Perceptible" or "Marked". For oozing/crusting the available answers are "None" or "Present."

Outcome measures

Outcome measures
Measure	Placebo Intravenous Every 4 Weeks n=18 Participants Placebo intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.	Spesolimab 600 mg Intravenous Every 4 Weeks n=33 Participants 600 milligram (mg) Spesolimab (BI 655130) intravenous (i.v.) infusion once every 4 weeks (q4w) during the double blind period from week 0 to 16 (4 treatments in total). At week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI≥75 were classified as responders and patients with EASI\<75 were classified as non-responders. Responders received no further treatment, non-responders were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28). End of study was at week 44.
Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16 Week 4	1 Participants	2 Participants
Number of Patients Achieving at Least a 2-grade Reduction From Baseline to Clear (0) or Almost Clear (1) in Investigator's Global Assessment (IGA) at Week 4 and 16 Week 16	0 Participants	3 Participants

Adverse Events

Placebo (Week 1-16) and if no Treatment, Week 16-28

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Spesolimab (Week 1-16) and no Treatment (Week 16-28)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Spesolimab (Open Label Period, Week 16-44)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (Week 1-16) and if no Treatment, Week 16-28 n=18 participants at risk Placebo intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI\>=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI\<75 were classified as nonresponders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28.	Spesolimab (Week 1-16) and no Treatment (Week 16-28) n=33 participants at risk 600mg Spesolimab (BI 655130) intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI\>=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI\<75 were classified as non-responders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28.	Spesolimab (Open Label Period, Week 16-44) n=22 participants at risk Following the double blind period (week 0 to 16) patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI\<75 were classified as nonresponders and were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28), end of study is at week 44.
Cardiac disorders Acute myocardial infarction	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	3.0% 1/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Cardiac disorders Cardiac failure	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	4.5% 1/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Immune system disorders Hypersensitivity	5.6% 1/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	4.5% 1/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	4.5% 1/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Psychiatric disorders Depression	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	3.0% 1/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	4.5% 1/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	3.0% 1/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.00% 0/18 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	3.0% 1/33 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).	0.00% 0/22 • Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44). Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial. Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).

Other adverse events

Additional Information

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Principal investigator is a sponsor employee
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