NCT05516979
Completed
Phase 2
A Double-blind, Multi-center, Randomized, Placebo-controlled Study of the Safety and Efficacy of 12 Weeks Extended Treatment With AP1189 in Early Rheumatoid Arthritis (RA) Patients naïve to DMARD Treatment
Overview
- Phase
- Phase 2
- Intervention
- 100 mg AP1189
- Conditions
- Rheumatoid Arthritis
- Sponsor
- SynAct Pharma Aps
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Change in ACR20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate (MTX).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Confirmed diagnosis of RA according to the 2010 ACR/EULAR RA classification criteria and are ACR class I-III
- •≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts).
- •Candidate for MTX treatment
- •Is about to begin treatment with MTX
- •Must meet at least one of the following parameters at Screening:
- •positive result for anti-CCP or RF
- •Serum CRP ≥ 6 mg/L
- •Highly active RA (CDAI \> 22) at screening and baseline
- •Negative QuantiFERON-in-Tube test (QFG-IT)
- •Females of child-bearing potential must use of highly effective birth control method
Exclusion Criteria
- •Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within 1 month following randomization
- •Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA. Sjögren's syndrome with RA is allowable
- •Prior history of or current inflammatory joint disease other than RA
- •Subjects with fibromyalgia
- •Use of hydroxychloroquine within 4 weeks prior the Screening Visit
- •Initiation of, or change in existing NSAID treatment within 2 weeks prior to the baseline visit
- •Corticosteroids except inhaled or nasal formulations for seasonal allergy or asthma are prohibited within 2 weeks prior to screening
- •Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
- •Have prior renal transplant, current renal dialysis, or severe renal insufficiency
- •Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
Arms & Interventions
100 mg AP1189
Treatment period of 12 weeks given as 1 tablet daily
Intervention: 100 mg AP1189
Placebo
Treatment period of 12 weeks given as 1 tablet daily
Intervention: Placebo
Outcomes
Primary Outcomes
Change in ACR20
Time Frame: 12 weeks
The change in American College of Rheumatology 20% (ACR20) compared to baseline
Number of reported AEs
Time Frame: 12 weeks
Evaluation of the safety and tolerability of AP1189 on the number and severity of reported Adverse Events, compared with placebo
Secondary Outcomes
- Change in ACR70(12 weeks)
- Change in DAS-28(12 weeks)
- Change in ACR50(12 weeks)
- Change in (CDAI)(12 weeks)
Study Sites (1)
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