drugset / Trial / NCT03835481
A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is
Non-randomizedParallel-groupDouble-blindTreatment
Summary
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate to severe chronic plaque psoriasis.
Timeline
- Start
- 2019-03-18
- Primary completion
- 2021-06-22
- Completion
- 2021-07-27
Publications
- Gooderham MJ, Mrowietz U, Kadus W, Drda K, Gu H, Vangerow H, Flack M, Korell J, Sofen H, Papp KA. Phase II Randomized Trial of BI 730357, an Oral RORgammat Inhibitor, for Moderate-to-Severe Plaque Psoriasis. J Invest Dermatol. 2025 Aug;145(8):1969-1978.e14. doi: 10.1016/j.jid.2024.12.025. Epub 2025 Jan 21.
- Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 730357 | Unknown | 25 mg | Oral |
| Subject | BI 730357 | Unknown | 50 mg | Oral |
| Subject | BI 730357 | Unknown | 100 mg | Oral |
| Subject | BI 730357 | Unknown | 200 mg | Oral |
| Subject | BI 730357 | Unknown | 400 mg | Oral |