Trial Outcomes & Findings for A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is (NCT NCT03835481)

Last Updated: 2022-11-18

Results Overview

Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2. Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg). Period 2: Only patients who participated in period 2 are reported by dose sequence group. For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

165 participants

Primary outcome timeframe

For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.

Results posted on

2022-11-18

Participant Flow

This was a multicentre, long-term extension trial in patients with moderate-to-severe plaque psoriasis who completed treatment in the preceding trial 1407-0030 (NCT03635099). Patients rolling over from Part 1 of 1407-0030 remained on their blinded BI 730357 dose treatment, until the open label period of 1407-0005 started at Day 1 of week 13 (dose group 25-200 mg). Patients rolling over from Part 2 of 1407-0030 were assigned at visit 1 to receive open label treatment with 400 mg BI 737357.

All subjects were screened for eligibility prior to participation in the trial. Only subjects which met all inclusion and none of the exclusion criteria were included in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	25 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.
Double-blind Period STARTED	2	20	16	49	78
Double-blind Period COMPLETED	2	18	15	46	37
Double-blind Period NOT COMPLETED	0	2	1	3	41
Open Label Period (After Week 12) STARTED	0	0	35	46	37
Open Label Period (After Week 12) COMPLETED	0	0	0	0	0
Open Label Period (After Week 12) NOT COMPLETED	0	0	35	46	37

Reasons for withdrawal

Reasons for withdrawal
Measure	50 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.
Double-blind Period Other not stated below	0	0	1	1
Double-blind Period Termination of treatment by sponsor	0	0	0	35
Double-blind Period Withdrawal by Subject	0	1	0	5
Double-blind Period Lost to Follow-up	0	0	1	0
Double-blind Period Protocol Violation	2	0	1	0
Open Label Period (After Week 12) Termination of treatment by Sponsor	0	23	31	35
Open Label Period (After Week 12) Withdrawal by Subject	0	7	9	1
Open Label Period (After Week 12) Lost to Follow-up	0	4	3	0
Open Label Period (After Week 12) Adverse Event	0	1	1	0
Open Label Period (After Week 12) Covid-19 related, not due to Adverse event	0	0	1	0
Open Label Period (After Week 12) Other not stated above	0	0	1	1

Baseline Characteristics

A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	25 mg BI 730357 n=2 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=20 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=16 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=49 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=78 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	Total n=165 Participants Total of all reporting groups
Age, Continuous	41.0 Years STANDARD_DEVIATION 2.8 • n=5 Participants	47.2 Years STANDARD_DEVIATION 18.3 • n=7 Participants	58.1 Years STANDARD_DEVIATION 13.5 • n=5 Participants	49.9 Years STANDARD_DEVIATION 13.3 • n=4 Participants	44.5 Years STANDARD_DEVIATION 13.3 • n=21 Participants	47.7 Years STANDARD_DEVIATION 14.4 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	12 Participants n=4 Participants	22 Participants n=21 Participants	49 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	37 Participants n=4 Participants	56 Participants n=21 Participants	116 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants	23 Participants n=21 Participants	44 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	37 Participants n=4 Participants	55 Participants n=21 Participants	121 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	15 Participants n=8 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants	12 Participants n=8 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	17 Participants n=7 Participants	13 Participants n=5 Participants	42 Participants n=4 Participants	64 Participants n=21 Participants	137 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.

Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. For dose groups 25 mg - 200 mg BI, results are reported separately for period 1 and period 2. For dose group 400 mg BI, results are reported overall (period 1 + period 2).

Outcome measures

Outcome measures
Measure	25 mg BI 730357 n=2 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=20 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=16 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=49 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=78 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	25 mg BI - 100 mg BI n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	25 mg BI - 100 mg BI - 200 mg BI n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	50 mg BI - 100 mg BI n=5 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	50 mg BI - 100 mg BI - 200 mg BI n=13 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	100 mg BI - 100 mg BI n=6 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	100 mg BI - 100 mg BI - 200 mg BI n=9 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	200 mg BI - 200 mg BI n=46 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	0 Participants	6 Participants	6 Participants	10 Participants	14 Participants	1 Participants	0 Participants	3 Participants	8 Participants	3 Participants	6 Participants	28 Participants

SECONDARY outcome

Timeframe: At baseline and at week 24.

Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.

Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100. The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) \*100, at all visits with PASI collected.

Outcome measures

Outcome measures
Measure	25 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=4 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=13 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=6 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	25 mg BI - 100 mg BI n=9 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	25 mg BI - 100 mg BI - 200 mg BI n=45 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	50 mg BI - 100 mg BI n=16 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	50 mg BI - 100 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	100 mg BI - 100 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	100 mg BI - 100 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	200 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 PASI50	0 Participants	1 Participants	4 Participants	12 Participants	2 Participants	8 Participants	33 Participants	9 Participants	—	—	—	—
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 PASI75	0 Participants	1 Participants	3 Participants	9 Participants	2 Participants	3 Participants	23 Participants	6 Participants	—	—	—	—
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 PASI90	0 Participants	1 Participants	1 Participants	4 Participants	0 Participants	2 Participants	10 Participants	5 Participants	—	—	—	—
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24 PASI100	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At week 24.

Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome. 0= clear (no signs of psoriasis), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration).

Outcome measures

Outcome measures
Measure	25 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=4 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=13 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=6 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	25 mg BI - 100 mg BI n=9 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	25 mg BI - 100 mg BI - 200 mg BI n=45 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	50 mg BI - 100 mg BI n=16 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	50 mg BI - 100 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	100 mg BI - 100 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	100 mg BI - 100 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	200 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).
Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24	0 Participants	1 Participants	2 Participants	5 Participants	1 Participants	3 Participants	18 Participants	7 Participants	—	—	—	—

SECONDARY outcome

Timeframe: At week 24.

Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome. 0= clear (No signs of psoriasis), 1. almost clear; 2. mild; 3. moderate; 4 = severe (e.g. deep dark red coloration).

Outcome measures

Outcome measures
Measure	25 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=4 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=13 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=6 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	25 mg BI - 100 mg BI n=9 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	25 mg BI - 100 mg BI - 200 mg BI n=45 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	50 mg BI - 100 mg BI n=16 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	50 mg BI - 100 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	100 mg BI - 100 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	100 mg BI - 100 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	200 mg BI - 200 mg BI Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).
Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	3 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Up to 802 days.

Population: Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.

The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported. PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome. A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.

Outcome measures

Outcome measures
Measure	25 mg BI 730357 n=2 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=3 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=41 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=1 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	25 mg BI - 100 mg BI n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	25 mg BI - 100 mg BI - 200 mg BI n=5 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	50 mg BI - 100 mg BI n=13 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	50 mg BI - 100 mg BI - 200 mg BI n=6 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	100 mg BI - 100 mg BI n=9 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	100 mg BI - 100 mg BI - 200 mg BI n=46 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	200 mg BI - 200 mg BI n=37 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI90 Responders	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	5 Participants	0 Participants	3 Participants	21 Participants	10 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI50 Responders	0 Participants	1 Participants	2 Participants	23 Participants	1 Participants	1 Participants	5 Participants	13 Participants	6 Participants	9 Participants	46 Participants	30 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI50 Loss of Response	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	5 Participants	3 Participants	11 Participants	4 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI75 Responders	0 Participants	1 Participants	0 Participants	12 Participants	1 Participants	1 Participants	4 Participants	12 Participants	3 Participants	6 Participants	32 Participants	21 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI75 Loss of Response	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants	1 Participants	12 Participants	5 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI90 Loss of Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	12 Participants	2 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI100 Responders	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	4 Participants	0 Participants	1 Participants	12 Participants	4 Participants
Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response PASI100 Loss of Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	7 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 802 days.

The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported. The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome). A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.

Outcome measures

Outcome measures
Measure	25 mg BI 730357 n=2 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=3 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=41 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=1 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	25 mg BI - 100 mg BI n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	25 mg BI - 100 mg BI - 200 mg BI n=5 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	50 mg BI - 100 mg BI n=13 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	50 mg BI - 100 mg BI - 200 mg BI n=6 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	100 mg BI - 100 mg BI n=9 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	100 mg BI - 100 mg BI - 200 mg BI n=46 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	200 mg BI - 200 mg BI n=37 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).
Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response Resonders	0 Participants	1 Participants	0 Participants	13 Participants	0 Participants	1 Participants	3 Participants	9 Participants	3 Participants	6 Participants	32 Participants	17 Participants
Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response Loss of response	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	4 Participants	3 Participants	2 Participants	18 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 802 days.

The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported. The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome). A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.

Outcome measures

Outcome measures
Measure	25 mg BI 730357 n=2 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	50 mg BI 730357 n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	100 mg BI 730357 n=3 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.	200 mg BI 730357 n=41 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).	400 mg BI 730357 n=1 Participants Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.	25 mg BI - 100 mg BI n=1 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	25 mg BI - 100 mg BI - 200 mg BI n=5 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	50 mg BI - 100 mg BI n=13 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	50 mg BI - 100 mg BI - 200 mg BI n=6 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	100 mg BI - 100 mg BI n=9 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).	100 mg BI - 100 mg BI - 200 mg BI n=46 Participants Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).	200 mg BI - 200 mg BI n=37 Participants Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).
Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response Resonders	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	4 Participants	0 Participants	1 Participants	12 Participants	4 Participants
Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response Loss of response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	7 Participants	1 Participants

Adverse Events

25 mg BI 730357 (Actual Dose)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

50 mg BI 730357 (Actual Dose)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

100 mg BI 730357 BI (Actual Dose)

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

200 mg BI 730357 (Actual Dose)

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

400 mg BI 730357 (Actual Dose)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	25 mg BI 730357 (Actual Dose) n=2 participants at risk Patients received 25 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 25 mg BI 730357.	50 mg BI 730357 (Actual Dose) n=20 participants at risk Patients received 50 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 50 mg BI 730357.	100 mg BI 730357 BI (Actual Dose) n=36 participants at risk Patients who received 100 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 100 mg BI 730357.	200 mg BI 730357 (Actual Dose) n=72 participants at risk Patients received 200 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 200 mg BI 730357.	400 mg BI 730357 (Actual Dose) n=78 participants at risk Patients received 400 mg of BI 730357 orally once daily under fed conditions throughout the trial. This group includes all subjects who actually received 400 mg BI 730357.
Cardiac disorders Pericarditis	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	1.4% 1/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Infections and infestations Erysipelas	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	2.8% 1/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Infections and infestations Pyelonephritis	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	1.4% 1/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Infections and infestations Urosepsis	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	1.4% 1/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	2.8% 1/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	5.0% 1/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	2.8% 1/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	1.4% 1/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	1.4% 1/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.

Other adverse events

Other adverse events
Measure	25 mg BI 730357 (Actual Dose) n=2 participants at risk Patients received 25 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 25 mg BI 730357.	50 mg BI 730357 (Actual Dose) n=20 participants at risk Patients received 50 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 50 mg BI 730357.	100 mg BI 730357 BI (Actual Dose) n=36 participants at risk Patients who received 100 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 100 mg BI 730357.	200 mg BI 730357 (Actual Dose) n=72 participants at risk Patients received 200 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 200 mg BI 730357.	400 mg BI 730357 (Actual Dose) n=78 participants at risk Patients received 400 mg of BI 730357 orally once daily under fed conditions throughout the trial. This group includes all subjects who actually received 400 mg BI 730357.
Infections and infestations Nasopharyngitis	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	10.0% 2/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	5.6% 2/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	4.2% 3/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	5.0% 1/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	8.3% 3/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	2.8% 2/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	5.6% 2/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	1.4% 1/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	8.3% 3/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	2.8% 2/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	5.6% 4/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Nervous system disorders Headache	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	8.3% 3/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	4.2% 3/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	1.3% 1/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	5.6% 2/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/2 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/20 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	5.6% 2/36 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	2.8% 2/72 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.	0.00% 0/78 • From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days. Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.

Additional Information

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Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

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