274
Participants
Start Date
September 17, 2018
Primary Completion Date
May 6, 2021
Study Completion Date
May 26, 2021
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).
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).
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).
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).
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).
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.
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.
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.
Icahn School of Medicine at Mount Sinai, New York
Charité - Universitätsmedizin Berlin, Berlin
TFS Trial Form Support GmbH, Hamburg
Virginia Clinical Research, Inc., Norfolk
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck
Clinical Research Center of the Carolinas, Charleston
Hamilton Research, Alpharetta
Advanced Medical Research PC, Sandy Springs
Total Skin and Beauty Dermatology Center, PC, Birmingham
Studienzentrum im Jahrhunderthaus, Bochum
Synexus, Cincinnati
Dawes Fretzin Clinical Research Group, LLC, Indianapolis
Universitätsklinikum Münster, Münster
Health Concepts, Rapid City
Universitätsklinikum Frankfurt, Frankfurt am Main
Universitätsklinikum Heidelberg, Heidelberg
Menter Dermatology Research Institute, Dallas
Center for Clinical Studies, Houston
Center for Clinical Studies, Webster
Dermatology Research Associates, Los Angeles
Southern California Dermatology Inc., Santa Ana
The Psoriasis Treatment Center of Central New Jersey, East Windsor
Clinical Partners, LLC, Johnston
Dr Chih-ho Hong Medical Inc, Surrey
Enverus Medical Research, Surrey
Dr. Irina Turchin PC Inc., Fredericton
The Guenther Dermatology Research Centre, London
DermEdge Research Inc., Mississauga
North Bay Dermatology Centre, North Bay
The Centre for Clinical Trials, Oakville
SKiN Centre for Dermatology, Peterborough
The Centre for Dermatology, Richmond Hill
K. Papp Clinical Research Inc., Waterloo
XLR8 Medical Research Inc., Windsor
Lead Sponsor
Boehringer Ingelheim
INDUSTRY