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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

NCT06671054 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-10-06

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

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

Sponsors & Collaborators

  • NBCD A/S

    collaborator INDUSTRY

  • SynAct Pharma Aps

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Denmark
  • Moldova
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671054 on ClinicalTrials.gov