Trials / Completed
CompletedNCT05516979
A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment
A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- SynAct Pharma Aps · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 100 mg AP1189 | AP1189 tablets for oral use |
| DRUG | Placebo | Matching placebo for oral use |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2023-07-20
- Completion
- 2023-07-20
- First posted
- 2022-08-26
- Last updated
- 2023-11-07
Locations
1 site across 1 country: Moldova
Source: ClinicalTrials.gov record NCT05516979. Inclusion in this directory is not an endorsement.