drugset / Trial / NCT03963401
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a 52 week Phase 2b study designed to evaluate the efficacy at 16 weeks and to evaluate the safety and efficacy up to 1 year in subjects with active psoriatic arthritis.
Timeline
- Start
- 2019-06-13
- Primary completion
- 2020-04-06
- Completion
- 2021-01-15
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs PF-06700841 30 mg QD; p = 0.0197; Median Difference (Final Values) 23.38 (90% CI 9.26 to 37.50) NCT03963401 ↗
registry analysis (superiority test); Placebo vs PF-06700841 60 mg QD; p = 0.0006; Median Difference (Final Values) 31.29 (90% CI 17.65 to 44.93) NCT03963401 ↗
paper Treatment with brepocitinib at dosages of 30 mg and 60 mg once daily was superior to placebo at reducing signs and symptoms of PsA. PMID 37194394 ↗
Publications
- Background Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.
- Mease P, Helliwell P, Silwinska-Stanczyk P, Miakisz M, Ostor A, Peeva E, Vincent MS, Sun Q, Sikirica V, Winnette R, Qiu R, Li G, Feng G, Beebe JS, Martin DA. Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial. Arthritis Rheumatol. 2023 Aug;75(8):1370-1380. doi: 10.1002/art.42519. Epub 2023 Jun 22.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brepocitinib | Small molecule | 30 mg | — |
| Subject | Brepocitinib | Small molecule | 60 mg | — |