Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated October 6, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-10-31; most recent amendment 2025-10-03.
Trial Details
NCT Number NCT06671054
Lead Sponsor SynAct Pharma Aps
Collaborators: NBCD A/S
Conditions Rheumatoid Arthritis (RA)
Enrollment 240 participants
Start Date 2024-10-01
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-06