Actively Recruiting
A Randomized, Double Blind, Placebo-Controlled, Dose Response Phase II Trial Evaluating Oral AP1189 at 40, 70, or 100 mg with Methotrexate in DMARD-Naive Early Rheumatoid Arthritis Participants
Led by SynAct Pharma Aps · Updated on 2025-10-06
240
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
Sponsors
S
SynAct Pharma Aps
Lead Sponsor
N
NBCD A/S
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of oral AP1189 combined with methotrexate in adults with early rheumatoid arthritis who have not previously been treated with disease-modifying anti-rheumatic drugs (DMARDs). This phase II, randomized, double-blind, placebo-controlled study aims to understand how different doses of AP1189 (40, 70, or 100 mg) impact disease activity and inflammation over 12 weeks in participants with active early rheumatoid arthritis. Participants will be randomly assigned to one of four groups, each receiving daily oral treatment for 12 weeks: AP1189 at 40 mg, 70 mg, or 100 mg doses alongside methotrexate, or a placebo alongside methotrexate. The study compares the effects of these treatments on rheumatoid arthritis symptoms and inflammation to determine the best dose of AP1189 when combined with methotrexate. During the study, participants will attend scheduled visits for assessments including joint evaluations, blood tests for inflammation markers such as C-reactive protein (CRP), and other safety monitoring. Researchers will measure changes in the Disease Activity Score 28 (DAS28)-CRP at 12 weeks to evaluate treatment impact. Participants will be monitored closely for safety and tolerability throughout the trial period, which lasts about 12 weeks.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent obtained before any trial-specific procedure
- Definite rheumatoid arthritis diagnosis by 2010 ACR/EULAR criteria
- Disease duration no longer than 6 months from diagnosis and symptoms not exceeding 18 months
- Naive to any disease-modifying anti-rheumatic drugs (DMARDs)
- At least 6 tender and 6 swollen joints at screening and baseline
- High disease activity with DAS28-CRP score greater than 5.1 and CDAI greater than 22 at screening and baseline
- Serum high sensitive C-Reactive Protein (hsCRP) at or above 3 mg/L at screening
- Positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) antibodies; if seronegative, hsCRP at or above 6 mg/L at screening
- Willing and able to comply with study visits, treatment plan, and procedures
- Females of childbearing potential must have negative pregnancy tests at screening and baseline
- Participants practicing two methods of birth control during the study and for 90 days after last dose or remaining abstinent during these periods
You will not qualify if you...
- Functional class IV of global functional status in rheumatoid arthritis
- Other rheumatic autoimmune diseases or significant systemic involvement secondary to rheumatoid arthritis
- Current inflammatory joint diseases other than rheumatoid arthritis
- Non-inflammatory musculoskeletal conditions interfering with rheumatoid arthritis diagnosis or study evaluations
- Gastrointestinal diseases affecting medication absorption or excretion
- Severe, progressive, or uncontrolled diseases affecting renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurologic systems
- Active malignancy within 12 months before screening
- Acute or chronic hepatitis, elevated liver enzymes beyond defined limits, or HIV infection
- History of alcohol or drug abuse within 12 months prior to screening
- Vaccination with live vaccines within 6 weeks before screening
- Low hemoglobin, hematocrit, white blood cell, neutrophil, or platelet counts at screening
- Elevated liver enzymes or bilirubin above specified limits at screening
- Estimated creatinine clearance below 45 mL/min/1.73 m2 at screening
- Abnormal clinically significant ECG findings at screening
- Positive QuantiFERON-in-Tube test
- Use of hydroxychloroquine within 30 weeks before screening
- Systemic or intraarticular corticosteroid treatment within 6 weeks before screening
- Unstable or recent nonsteroidal anti-inflammatory drug (NSAID) use unless stable for at least 4 weeks prior
- Use of other investigational drugs or clinical trial participation within 6 months before screening
- Any other clinically relevant conditions judged by the investigator to affect safety or study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive daily oral treatment with AP1189 at doses of 40 mg, 70 mg, 100 mg, or matching placebo, in combination with Methotrexate (MTX), to evaluate efficacy and safety.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 11 locations
1
Nouvelle Clinical Research LLC
Cutler Bay, Florida, United States, 33189
Actively Recruiting
2
Millennium Medical Research LLC
Miami, Florida, United States, 33126
Actively Recruiting
3
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
4
Diagnostic Consultative Center Aleksandrovska
Sofia, Bulgaria, 1431
Actively Recruiting
5
Medical Center Tera Medico
Vratsa, Bulgaria, 3000
Actively Recruiting
6
Sanos Clinic Herlev
Herlev, Denmark, 2730
Actively Recruiting
7
IMSP Spitalul Clinic Municipal "Sfanta Treime"
Chisinau, Moldova, 2068
Actively Recruiting
8
M2Mmed
Chorzów, Poland, 41-500
Actively Recruiting
9
Vita Longa Sp. z o. o.
Katowice, Poland, 41-500
Actively Recruiting
10
Medyczne Centrum Hetmańska
Poznan, Poland, 60-218
Actively Recruiting
11
DC-MED Michal Kowalski S.K.
Swidnica, Poland, 58-100
Actively Recruiting
Research Team
T
Thomas Jonassen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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