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NCT06671054 · ClinicalTrials.gov registry record · Phase 2
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 Phase 2 study of Rheumatoid Arthritis (RA), sponsored by SynAct Pharma Aps.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 11
- Study locations
NCT06671054: Recruiting Phase 2 study of Rheumatoid Arthritis (RA), sponsored by SynAct Pharma Aps.
NCT06671054 is a Phase 2 study of Rheumatoid Arthritis (RA) that is actively recruiting participants, run by SynAct Pharma Aps. The registered enrollment target is 240 participants, roughly in line with the 254-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target. The trial reports 11 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06671054, a Phase 2 study of Rheumatoid Arthritis (RA), is actively recruiting participants, sponsored by SynAct Pharma Aps.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 11
- Study locations
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.
Primary Outcome
Absolute change from baseline in DAS28-CRP at Week 12
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 |
What NCT06671054 shows while recruiting
NCT06671054 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 254-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target.
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.
NCT06671054 lists 11 locations in 3 states (Other, Florida, Pennsylvania).
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).
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).
Who is sponsoring clinical trial NCT06671054?
This trial is sponsored by SynAct Pharma Aps, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06671054's enrollment target sits among peer trials
240 5th of 17 higher than 13 of 17 other Rheumatoid Arthritis (RA) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis (RA) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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