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 Interventional Study
Rheumatoid Arthritis (RA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
SynAct Pharma Aps · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Signed and dated informed consent obtained before undergoing any trial-specific procedure. * Participants with definite RA diagnosis according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. * Disease durat…
Contacts

Thomas Jonassen, MD

+45 4015 6669

tj@synactpharma.com

CONTACT