This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is

PHASE2CompletedINTERVENTIONAL
Enrollment

274

Participants

Timeline

Start Date

September 17, 2018

Primary Completion Date

May 6, 2021

Study Completion Date

May 26, 2021

Conditions
Psoriasis
Interventions
DRUG

Placebo (fasted)

Placebo matching BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).

DRUG

BI 25 mg (fasted)

25 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).

DRUG

BI 50 mg (fasted)

50 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).

DRUG

BI 100 mg (fasted)

100 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).

DRUG

BI 200 mg (fasted)

200 milligram (mg) BI 730357 taken orally once daily as a film-coated tablet in the morning while fasted for 12 weeks in period 1 followed by the same treatment for 12 weeks in period 2 (total treatment period of 24 weeks).

DRUG

Placebo (fed)

4 film-coated tablets of matching Placebo were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.

DRUG

BI 400 mg once daily (fed)

4 film-coated tablets of 100 milligram (mg) BI 730357 (400 mg in total) were taken orally in the morning with a meal and 2 film-coated tablets of matching Placebo were taken orally in the evening with a meal for 12 weeks.

DRUG

BI 200 mg twice daily, 400 mg total (fed)

2 film-coated tablets of 100 milligram (mg) BI 730357 were taken orally with a meal in the morning and evening (twice daily; total daily dosage: 400 mg) for 12 weeks.

Trial Locations (34)

10003

Icahn School of Medicine at Mount Sinai, New York

10117

Charité - Universitätsmedizin Berlin, Berlin

20537

TFS Trial Form Support GmbH, Hamburg

23502

Virginia Clinical Research, Inc., Norfolk

23538

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck

29407

Clinical Research Center of the Carolinas, Charleston

30022

Hamilton Research, Alpharetta

30328

Advanced Medical Research PC, Sandy Springs

35205

Total Skin and Beauty Dermatology Center, PC, Birmingham

44793

Studienzentrum im Jahrhunderthaus, Bochum

45236

Synexus, Cincinnati

46250

Dawes Fretzin Clinical Research Group, LLC, Indianapolis

48149

Universitätsklinikum Münster, Münster

57702

Health Concepts, Rapid City

60596

Universitätsklinikum Frankfurt, Frankfurt am Main

69120

Universitätsklinikum Heidelberg, Heidelberg

75246

Menter Dermatology Research Institute, Dallas

77004

Center for Clinical Studies, Houston

77598

Center for Clinical Studies, Webster

90045

Dermatology Research Associates, Los Angeles

92701

Southern California Dermatology Inc., Santa Ana

08520

The Psoriasis Treatment Center of Central New Jersey, East Windsor

02919

Clinical Partners, LLC, Johnston

V3R 6A7

Dr Chih-ho Hong Medical Inc, Surrey

V3V 0C6

Enverus Medical Research, Surrey

E3B 1G9

Dr. Irina Turchin PC Inc., Fredericton

N6A 3H7

The Guenther Dermatology Research Centre, London

L5H 1G9

DermEdge Research Inc., Mississauga

P1B 3Z7

North Bay Dermatology Centre, North Bay

L6J 7W5

The Centre for Clinical Trials, Oakville

K9J 5K2

SKiN Centre for Dermatology, Peterborough

L4B 1A5

The Centre for Dermatology, Richmond Hill

N2J 1C4

K. Papp Clinical Research Inc., Waterloo

N8W 1E6

XLR8 Medical Research Inc., Windsor

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY