drugset / Trial / NCT03881059
Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2020-04-27
- Completion
- 2021-01-27
Outcome
Met primary endpoint
paper ACR-20 response was significantly higher with deucravacitinib 6 mg once a day (52.9%, p=0.0134) and 12 mg once a day (62.7%, p=0.0004) versus placebo PMID 35241426 ↗
registry analysis (superiority test); Placebo vs BMS-986165 6 mg vs BMS-986165 12 mg; p <0.001; NCT03881059 ↗
release “Late-breaking data from a Phase 2 trial evaluating deucravacitinib in patients with active psoriatic arthritis, which met the primary endpoint and key secondary objectives.” bms.com ↗
Publications
- Deodhar A, Nowak M, Ye JY, Lehman T, Banerjee S, Mease PJ. Efficacy and Safety of Deucravacitinib, a Selective, Allosteric TYK2 Inhibitor, by Baseline DMARD Use in a Phase 2 Psoriatic Arthritis Study: A Post Hoc Analysis. Rheumatol Ther. 2025 Oct;12(5):873-887. doi: 10.1007/s40744-025-00776-4. Epub 2025 Jul 5.
- FitzGerald O, Gladman DD, Mease PJ, Ritchlin C, Smolen JS, Gao L, Hu Y, Nowak M, Banerjee S, Catlett I. Phase 2 Trial of Deucravacitinib in Psoriatic Arthritis: Biomarkers Associated With Disease Activity, Pharmacodynamics, and Clinical Responses. Arthritis Rheumatol. 2024 Sep;76(9):1397-1407. doi: 10.1002/art.42921. Epub 2024 Jul 1.
- Strand V, Gossec L, Coates LC, Ogdie A, Choi J, Becker B, Zhuo J, Lehman T, Nowak M, Elegbe A, Mease PJ, Deodhar A. Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial. Arthritis Care Res (Hoboken). 2024 Aug;76(8):1139-1148. doi: 10.1002/acr.25333. Epub 2024 May 7.
- Mease PJ, Deodhar AA, van der Heijde D, Behrens F, Kivitz AJ, Neal J, Kim J, Singhal S, Nowak M, Banerjee S. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 Jun;81(6):815-822. doi: 10.1136/annrheumdis-2021-221664. Epub 2022 Mar 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CRAVACITINIB | Small molecule | 6 mg | Oral |
| Subject | CRAVACITINIB | Small molecule | 12 mg | Oral |
| Subject | Ustekinumab | Monoclonal antibody | — | Subcutaneous |