A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment
Summary
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).
Timeline
- Start
- 2022-09-26
- Primary completion
- 2023-07-20
- Completion
- 2023-07-20
Outcome
Missed primary endpoint
release “The study did not meet its primary endpoint of significance over placebo with the ACR20 outcome.” synactpharma.com ↗
release “while the overall study did not achieve its primary endpoint” synactpharma.com ↗
release “the least square mean of reduction in DAS28-CRP (primary endpoint) in the per protocol subjects was 1.98 (SE 0.14) vs 1.79 (SE 0.14) in the placebo treated group (p=0.168).” synactpharma.com ↗
release “the primary endpoint inadequate to reach significance within the limits of the study design.” synactpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Resomelagon | Small molecule | 100 mg | Oral |