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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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.

NCT06671054•SynAct Pharma Aps

View on ClinicalTrials.gov

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.

Detailed Description

The purpose of the trial is to evaluate the efficacy, safety and tolerability of 12 weeks daily treatment of oral AP1189 at the doses of 40, 70, or 100 mg in combination with oral MTX compared to oral MTX alone. The aim is to have 240 participants randomized to one of the 4 treatment groups, in a 1:1:1:1 ratio and treated with both AP1189/Placebo and MTX.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+13 more criteria

Locations (11)

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

Key Dates

Start Date

October 1, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

October 6, 2025

Enrollment

240

ESTIMATED participants

Conditions

Rheumatoid Arthritis (RA)

Interventions

AP1189, 40 mg

DRUG

AP1189, 70 mg

DRUG

AP1189, 100 mg

DRUG

AP1189 matching placebo

DRUG

Contacts

Thomas Jonassen, MD

CONTACT

+45 4015 6669 tj@synactpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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