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

Part of paid clinical trials in Cutler Bay, Florida.

Sponsor
SynAct Pharma Aps
Study ID
NCT06671054
Phase
PHASE2
Status
Recruiting
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Conditions

  • Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AP1189, 40 mg — DRUG
    AP1189 tablets for oral use
  • AP1189, 70 mg — DRUG
    AP1189 tablets for oral use
  • AP1189, 100 mg — DRUG
    AP1189 tablets for oral use
  • AP1189 matching placebo — DRUG
    AP1189 tablets for oral use

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AP1189 40 mg
    12 weeks daily treatment of oral AP1189 40 mg as add-on to Methotrexate (MTX)
  • Experimental: AP1189 70 mg
    12 weeks daily treatment of oral AP1189 70 mg as add-on to Methotrexate (MTX)
  • Experimental: AP1189 100 mg
    12 weeks daily treatment of oral AP1189 100 mg as add-on to Methotrexate (MTX)
  • Experimental: Placebo
    12 weeks daily treatment of oral AP1189 matching placebo as add-on to Methotrexate (MTX)

Primary Outcome Measure

Change in Disease Activity Score 28 (DAS28)-C-Reactive Protein (CRP) [ Time Frame: Week 12 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Nouvelle Clinical Research LLCCutler BayFlorida33189
Rawan Jumean, MD
[email protected]
Millennium Medical Research LLCMiamiFlorida33126
Ramon Morada
[email protected]
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635
Alan Kiwitz, MD
[email protected]
(814) 693-0300

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Nouvelle Clinical Research LLC· Cutler Bay, FLMillennium Medical Research LLC· Miami, FLAltoona Center for Clinical Research· Duncansville, PA

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