drugset / Trial / NCT02719171
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis
RandomizedParallel-groupDouble-blindTreatment
Summary
The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic arthritis in order to select doses for further clinical trials.
Timeline
- Start
- 2016-04
- Primary completion
- 2017-05
- Completion
- 2017-08
Outcome
Met primary endpoint
paper Significantly more patients in each risankizumab arm achieved ACR20 at week 16 versus placebo (primary endpoint: pooled arms 1 + 2 [59.5%] versus placebo [35.7%]; PMID 35931879 ↗
registry p = 0.007; Mean Difference (Final Values) 24.0 (90% CI 9.3 to 38.7) NCT02719171 ↗
Publications
- Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.
- Mease PJ, Kellner H, Morita A, Kivitz AJ, Aslanyan S, Padula SJ, Topp AS, Eldred A, Behrens F, Papp KA. Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial. Rheumatol Ther. 2022 Oct;9(5):1361-1375. doi: 10.1007/s40744-022-00474-5. Epub 2022 Aug 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Risankizumab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Risankizumab | Monoclonal antibody | 150 mg | Subcutaneous |