drugset / Trial / NCT04004429
A Study of the Safety, Tolerability and Efficacy of Treatment With AP1189 in Early RA Patients With Active Joint Disease
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a multicenter, two-part, randomized, double-blind, placebo-kontrolled, 4-week study with repeated doses of AP1189. The study population will consist of newly diagnosed subjects with severe active Rheumatoid Arthritis, defined with a Clinical Disease Activity score (CDAI) \> 22, who are to start up-titration with methotrexate.
Timeline
- Start
- 2019-08-26
- Primary completion
- 2021-11-16
- Completion
- 2021-11-16
Outcome
Met primary endpoint
release “AP1189 achieves primary endpoint and favorable safety profile in patients with Rheumatoid Arthritis with ongoing active joint disease in the Phase 2a study BEGIN.” synactpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Resomelagon | Small molecule | 50 mg | — |
| Subject | Resomelagon | Small molecule | 100 mg | — |