drugset / Trial / NCT03000075
BI 655066 (Risankizumab) Compared to Placebo in Japanese Patients With Moderate to Severe Chronic Plaque Psoriasis
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a randomized double blind, double dummy, placebo controlled, parallel design study that is being performed to assess the safety and efficacy of BI 655066 (risankizumab).
Timeline
- Start
- 2016-12-02
- Primary completion
- 2017-09-21
- Completion
- 2018-06-20
Outcome
Met primary endpoint
paper All primary and psoriasis-related secondary end-points were met for both risankizumab doses (P < 0.001). PMID 31237727 ↗
registry Placebo (Part A) vs Risankizumab 75 mg (Part A); p < 0.001; Adjusted percentage difference 73.6 (95% CI 62.2 to 85.0) NCT03000075 ↗
Publications
- Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2.
- Ohtsuki M, Fujita H, Watanabe M, Suzaki K, Flack M, Huang X, Kitamura S, Valdes J, Igarashi A. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial. J Dermatol. 2019 Aug;46(8):686-694. doi: 10.1111/1346-8138.14941. Epub 2019 Jun 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risankizumab | Monoclonal antibody | 75 mg | — |
| Subject | Risankizumab | Monoclonal antibody | 150 mg | — |