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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG AP1189, 40 mg
- DRUG AP1189, 70 mg
- DRUG AP1189, 100 mg
- DRUG AP1189 matching placebo
Study Locations (11)
Other
- Diagnostic Consultative Center Aleksandrovska — Sofia
- Medical Center Tera Medico — Vratsa
- Sanos Clinic Herlev — Herlev
- IMSP Spitalul Clinic Municipal "Sfanta Treime" — Chisinau
- M2Mmed — Chorzów
- Vita Longa Sp. z o. o. — Katowice
- Medyczne Centrum Hetmańska — Poznan
- DC-MED Michal Kowalski S.K. — Swidnica
Florida
- Nouvelle Clinical Research LLC — Cutler Bay
- Millennium Medical Research LLC — Miami
Pennsylvania
- Altoona Center for Clinical Research — Duncansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06671054
The ClinicalTrials.gov registry entry for NCT06671054 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SynAct Pharma Aps, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Rheumatoid Arthritis (RA) appearing as the primary indexed condition, and to 4 interventions — of which AP1189, 40 mg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06671054 reports 11 study locations spanning 3 distinct geographic areas — top geographies include Other, Florida, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06671054 about?
NCT06671054 is a clinical study titled "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". 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 a...
What is the current status of trial NCT06671054?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2024-10-01. Estimated completion is 2025-12.
What conditions does trial NCT06671054 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis (RA). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06671054?
The interventions under investigation include: AP1189, 40 mg (DRUG), AP1189, 70 mg (DRUG), AP1189, 100 mg (DRUG), AP1189 matching placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06671054?
This trial is sponsored by SynAct Pharma Aps, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06671054 being conducted?
This trial has 11 study locations across Florida, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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