Recruiting
Phase 2

AP1189

Sponsor:

SynAct Pharma Aps

Code:

NCT06671054

Conditions

Rheumatoid Arthritis (RA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AP1189, 40 mg

AP1189, 70 mg

AP1189, 100 mg

AP1189 matching placebo

Study Details

Brief 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

Rheumatoid Arthritis (RA)

Study ID

NCT06671054

Start date

Oct 1, 2024

Status verified date

Oct, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • Sexually active female participants of childbearing potential and male participants are excluded if not practicing two different methods of birth control with their partner during the study and for 90 days after the last dose of study drug or who will not remain abstinent during the study and for 90 days after the last dose.

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.
  • Haemoglobin <9 g/dL or Haematocrit <30% at the Screening Visit
  • White blood cell (WBC) count <3.0 x 109/L at the Screening Visit.
  • Absolute neutrophil count <1.2 x 109/L at the Screening Visit.
  • Platelet count <100 x 109/L at the Screening Visit.
  • Serum alkaline-phosphatase, or gamma-glutamyl-transferase greater than 3-fold ULN; alanine aminotransferase, or aspartate aminotransferase, or total bilirubin greater than 2-fold ULN At the Screening Visit.
  • Estimated creatinine clearance less than 45 mL/min/1.73 m2 (MDRD) at the Screening Visit.
  • 12-lead electrocardiogram (ECG) with abnormal clinically significant findings, as judged by the Investigator, at the Screening Visit.
  • Positive QuantiFERON-in-Tube test (QFG-IT).
  • Use of hydroxychloroquine during the 30 weeks preceding the Screening Visit.
  • Treatment with any systemic or intraarticular corticosteroid within 6 weeks before the Screening Visit.
  • Intermittent use of nonsteroidal anti-inflammatory drugs (NSAIDs). Use of NSAIDs is allowed if used in a stable dose regimen for at least 4 weeks prior to the Screening Visit.
  • Use of other investigational drugs/treatments, or enrolment in a clinical trial during the 6 months preceding the Screening Visit.
  • Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

AP1189, 40 mg

AP1189 tablets for oral use

AP1189, 70 mg

AP1189 tablets for oral use

AP1189, 100 mg

AP1189 tablets for oral use

AP1189 matching placebo

AP1189 tablets for oral use

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Thomas Jonassen, MD

+45 4015 6669tj@synactpharma.com

Locations

Nouvelle Clinical Research LLC

Recruiting

Cutler Bay, Florida, United States, 33189

Contacts

Rawan Jumean, MD

info@nouvelleclinicalresearch.com

Millennium Medical Research LLC

Recruiting

Miami, Florida, United States, 33126

Contacts

Ramon Morada

drmoreda@millenniummedresearch.com

Altoona Center for Clinical Research

Recruiting

Duncansville, Pennsylvania, United States, 16635

Contacts

Alan Kiwitz, MD

altoonaresearch@gmail.com

(814) 693-0300

More Information

Sponsor

SynAct Pharma Aps

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SynAct Pharma Aps on 2025-10-06.