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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: SynAct Pharma Aps · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the trial is to evaluate the efficacy, safety and tolerability of 12 weeks daily treatment of oral AP1189 at the doses of 40, 70, or 100 mg in combination with oral MTX compared to oral MTX alone. The aim is to have 240 participants randomized to one of the 4 treatment groups, in a 1:1:1:1 ratio and treated with both AP1189/Placebo and MTX.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	AP1189, 40 mg	AP1189 tablets for oral use
DRUG	AP1189, 70 mg	AP1189 tablets for oral use
DRUG	AP1189, 100 mg	AP1189 tablets for oral use
DRUG	AP1189 matching placebo	AP1189 tablets for oral use

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-11-04
• Last updated: 2025-10-06

Locations

11 sites across 5 countries: United States, Bulgaria, Denmark, Moldova, Poland

Regulatory

• FDA-regulated drug study