RecruitingPhase 2NCT06671054

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.


Sponsor

SynAct Pharma Aps

Enrollment

240 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called AP1189 — which works differently from standard rheumatoid arthritis medications — in people who have been recently diagnosed with RA and have never taken disease-modifying drugs (DMARDs). The goal is to find the right dose and see how well it reduces joint inflammation. **You may be eligible if...** - You have a confirmed diagnosis of rheumatoid arthritis - Your RA was diagnosed within the last 6 months and symptoms started no more than 18 months ago - You have not yet taken any DMARD medications - You have active joint inflammation (at least 6 tender and 6 swollen joints) and a high disease activity score - Your CRP (an inflammation marker in your blood) is elevated **You may NOT be eligible if...** - You have severe functional disability from RA - You have lupus, scleroderma, or another autoimmune disease in addition to RA - You have serious kidney, liver, or heart problems - You have gastrointestinal conditions affecting drug absorption - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAP1189, 40 mg

AP1189 tablets for oral use

DRUGAP1189, 70 mg

AP1189 tablets for oral use

DRUGAP1189, 100 mg

AP1189 tablets for oral use

DRUGAP1189 matching placebo

AP1189 tablets for oral use


Locations(11)

Nouvelle Clinical Research LLC

Cutler Bay, Florida, United States

Millennium Medical Research LLC

Miami, Florida, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Diagnostic Consultative Center Aleksandrovska

Sofia, Bulgaria

Medical Center Tera Medico

Vratsa, Bulgaria

Sanos Clinic Herlev

Herlev, Denmark

IMSP Spitalul Clinic Municipal "Sfanta Treime"

Chisinau, Moldova

M2Mmed

Chorzów, Poland

Vita Longa Sp. z o. o.

Katowice, Poland

Medyczne Centrum Hetmańska

Poznan, Poland

DC-MED Michal Kowalski S.K.

Swidnica, Poland

View Full Details on ClinicalTrials.gov

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NCT06671054


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