drugset / Trial / NCT06671054
A Dose Response Study to Evaluate the Efficacy and Safety of Oral AP1189 Administered in Disease-Modifying Anti-Rheumatic Drug (DMARD) naïve Participants Participants With Early Rheumatoid Arthritis
RandomizedParallel-groupTriple-blindTreatment
Summary
The study is a randomized, double blind, placebo-controlled, dose response, phase II, multicentre trial to evaluate the efficacy and safety of oral AP1189 administered at the doses of 40, 70, or 100 mg for 12 weeks in combination with methotrexate, in DMARD-naïve participants with early rheumatoid arthritis and active inflammation.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2025-12
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Resomelagon | Small molecule | 40 mg | Oral |
| Subject | Resomelagon | Small molecule | 70 mg | Oral |
| Subject | Resomelagon | Small molecule | 100 mg | Oral |