A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment

NCT ID: NCT05516979

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2023-07-20

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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

100 mg AP1189

Treatment period of 12 weeks given as 1 tablet daily

Group Type: EXPERIMENTAL

100 mg AP1189

Intervention Type: DRUG

AP1189 tablets for oral use

Placebo

Treatment period of 12 weeks given as 1 tablet daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo for oral use

Interventions

100 mg AP1189

AP1189 tablets for oral use

Intervention Type: DRUG

Placebo

Matching placebo for oral use

Intervention Type: DRUG

Other Intervention Names

AP1189 tablets for oral use

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:

1. positive result for anti-CCP or RF

2. 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
• Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured)
• Neuropathies or other painful conditions that might interfere with pain evaluation
• Body weight of >150 kg
• HBsAg positive and/or Anti-HBc with sign of current infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NBCD A/S

INDUSTRY

Sponsor Role: collaborator

SynAct Pharma Aps

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Timofei Mosneaga Republican Clinical Hospital

Chisinau, , Moldova

Countries

Moldova

Other Identifiers

SynAct-CS007

Identifier Type: -

Identifier Source: org_study_id