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AP1189 for Early Rheumatoid Arthritis

This study is testing a new oral medication called AP1189 for people with early rheumatoid arthritis (RA), a condition where your immune system attacks your joints. We want to see how effective and safe different doses of AP1189 (40 mg, 70 mg, or 100 mg) are when taken with methotrexate, compared to methotrexate alone. You may be able to join if you are 18 or older, have been recently diagnosed with RA, and haven't taken other disease-modifying anti-rheumatic drugs (DMARDs) yet. The main goal is to see how much your disease activity (DAS28-CRP) changes after 12 weeks. The study is currently recruiting about 240 participants.

Study design
This is a randomized, double-blind, placebo-controlled Phase 2 study involving about 240 participants. Participants will be randomly assigned to one of four groups, receiving either AP1189 at different doses or a placebo, all in combination with methotrexate.
What's involved
Participants will take oral AP1189/placebo and methotrexate daily for 12 weeks. The study will measure changes in your disease activity (DAS28-CRP) at Week 12.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring effectiveness is at Week 12.

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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

Recruiting
PHASE2Ages 18+InterventionalTreatment
SynAct Pharma Aps
~240 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:AP1189, 40 mgAP1189, 70 mgAP1189, 100 mgAP1189 matching placebo

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP)
Measured over Week 12

Conditions

Rheumatoid Arthritis (RA)

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NCT06671054

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvaniastudy coordinator listed

    Recruiting

  • DC-MED Michal Kowalski S.K.

    Swidnica, Polandstudy coordinator listed

    Recruiting

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Bulgariastudy coordinator listed

    Recruiting

  • IMSP Spitalul Clinic Municipal "Sfanta Treime"

    Chisinau, Moldovastudy coordinator listed

    Recruiting

  • M2Mmed

    Chorzów, Polandstudy coordinator listed

    Recruiting

  • Medical Center Tera Medico

    Vratsa, Bulgariastudy coordinator listed

    Recruiting

  • Medyczne Centrum Hetmańska

    Poznan, Polandstudy coordinator listed

    Recruiting

  • Millennium Medical Research LLC

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Thomas Jonassen, MD
[email protected]
+45 4015 6669
Email the study team

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Eligibility criteria

Inclusion

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 duration no longer than 6 months from diagnosis at the time of Baseline Visit and with a history of RA symptoms which does not exceed 18 months.
Participants must be naïve to any Disease-modifying anti-rheumatic drugs (DMARDs)
Participants with at least 6/68 tender and 6/66 swollen joints at Screening Visit and Baseline.
Participants with "high" disease activity as documented by a Disease Activity Score 28 (DAS28) (C-Reactive Protein - CRP) index score \> 5.1 at screening, and Clinical disease activity index (CDAI) \>22 at Screening Visit and Baseline.
Participants with serum high sensitive C-Reactive Protein (hsCRP) ≥3 mg/L at the time of screening.
Participants positive for serum rheumatoid factor (RF), AND/OR anti-cyclic citrullinated peptide antibodies (anti-CCP). If seronegative RA, hsCRP ≥6 mg/L at the time of screening.
Willing and able to comply with the scheduled study visits, the treatment plan, and all study procedures.
Females of childbearing potential must have a negative pregnancy test at screening and again at baseline.
Sexually active female participants of childbearing potential and male participants are excluded if not practicing two different methods of birth control with their partner during the study and for 90 days after the last dose of study drug or who will not remain abstinent during the study and for 90 days after the last dose.

Exclusion

Functional class IV of Global Functional Status in RA, as defined by the ACR Classification.
Rheumatic autoimmune disease other than RA, i.e. systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to RA.
Current inflammatory joint disease other than RA.
Non-inflammatory type of musculoskeletal condition that in the Investigator's opinion is symptomatic and/or severe enough to interfere with the subject's primary diagnosis of RA or the evaluation of the effect of the study drug.
Gastrointestinal diseases known to interfere with the absorption or excretion of medications.
Severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
Malignancy active during the 12 months preceding the Screening Visit.
Acute hepatitis, chronic hepatitis, or detection of any unexplained elevation of serum ALT or AST greater than 1.5-fold ULN, at least twice in the 6 months before the Screening Visit) or HIV infection.
History of alcohol or drug abuse during the 12 months preceding the Screening Visit.
Vaccination with live vaccines during the 6 weeks preceding the Screening Visit.
Haemoglobin \<9 g/dL or Haematocrit \<30% at the Screening Visit
White blood cell (WBC) count \<3.0 x 109/L at the Screening Visit.
Absolute neutrophil count \<1.2 x 109/L at the Screening Visit.
Platelet count \<100 x 109/L at the Screening Visit.
Serum alkaline-phosphatase, or gamma-glutamyl-transferase greater than 3-fold ULN; alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN At the Screening Visit.
Estimated creatinine clearance less than 45 mL/min/1.73 m2 (MDRD) at the Screening Visit.
12-lead electrocardiogram (ECG) with abnormal clinically significant findings, as judged by the Investigator, at the Screening Visit.
Positive QuantiFERON-in-Tube test (QFG-IT).
Use of hydroxychloroquine during the 30 weeks preceding the Screening Visit.
Treatment with any systemic or intraarticular corticosteroid within 6 weeks before the Screening Visit.
Intermittent use of nonsteroidal anti-inflammatory drugs (NSAIDs). Use of NSAIDs is allowed if used in a stable dose regimen for at least 4 weeks prior to the Screening Visit.
Use of other investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding the Screening Visit.
Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.

What this trial measures

  • Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP)Week 12

    Absolute change from baseline in DAS28-CRP at Week 12