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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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.

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) is a Phase 2 interventional studying Rheumatoid Arthritis (RA), sponsored by SynAct Pharma Aps. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Rheumatoid Arthritis (RA) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 240 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Rheumatoid Arthritis (RA) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Signed and dated willing to sign a consent form 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. Who Should NOT Join This Trial: - Functional class IV of Global Functional Status in RA, as defined by the ACR Classification. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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 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 Criteria: * 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.

Treatments Being Tested

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

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06671054), the sponsor (SynAct Pharma Aps), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06671054 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06671054?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06671054?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06671054. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06671054. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.