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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 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.

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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.

Conditions Studied

Rheumatoid Arthritis (RA)

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

FieldValue
Enrollment Target 240 participants
Start Date 2024-10-01
Est. Completion 2025-12
Phase Phase 2

Sponsor

SynAct Pharma Aps

1 total trials

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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, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 254-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target. The listed sponsor is SynAct Pharma Aps, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 11 study locations spanning 3 distinct geographic areas - top geographies include 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.

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