A Two-part, Randomized, Double-blind, Multi-center, Placebo-controlled Study of the Dose-range, Safety and Efficacy of 4 and 12 Weeks of Treatment With AP1189 in Adult Rheumatoid Arthritis (RA) Patients With an Inadequate Response to Methotrexate (MTX) Alone - (RESOLVE)

SynAct-CS006

The RESOLVE study is a two-part, randomized, double-blind, multi-center, placebo-controlled study of the safety, dose-range finding confirmation, and efficacy of 4 (Part A) and 12 weeks (Part B) of treatment with AP1189 in adult RA patients with an inadequate response to MTX alone.

2022-11-30

2024-04-30

2024-04-30

Recruiting

Early phase I

420

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) * Must meet at least one of the following parameters at Screening: 1. A positive result for Anti-Cyclic Citrullinated Peptide (anti-CCP) or Rheumatoid Factor (RF), 2. Serum CRP ≥ 6 mg/L based on central laboratory value * Ongoing methotrexate therapy ≥12 weeks in a stable dose of 7.5 to 25 mg/week for at least 4 weeks prior to the baseline visit * Subject has an inadequate clinical response to maximally tolerated methotrexate therapy * Subjects should be receiving an adequate and prescribed stable dose of folic acid (≥5 mg/week total dose or as per local clinical practice) which should be confirmed or initiated at screening and continued throughout the study * Negative QuantiFERON-in-Tube test (QFG-IT) * Females of child-bearing potential must use of highly effective birth control method * Male participant's partner must use highly effective birth control Exclusion Criteria: * Use of all other biologic or nonbiologic DMARDs and immunosuppressive therapy within 4 weeks prior to administration of the first dose of study drug * Oral steroids at a dose \>10 mg/day of prednisone or a prescription for oral steroids which has changed within 4 weeks of baseline * Receipt of an intra-articular or parenteral corticosteroid injection within 4 weeks prior to baseline * Major surgery (including joint operation) within 8 weeks prior to screening or planned surgery within the period of the study participation * Rheumatic autoimmune disease other than RA * Functional class IV as defined by the ACR Criteria for Classification of Functional Status in RA or wheelchair/bedbound * Prior history of or current inflammatory joint disease other than RA * Subjects with fibromyalgia * Initiation or change in dose for NSAIDs (including low-dose aspirin and Cyclooxygenase (COX-2) inhibitors) within 2 weeks prior to baseline * Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease * Serum Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) higher than 1.5 x the upper limit of normal (ULN) and alkaline phosphatase (ALP) and/or bilirubin values above the ULN at the screening visit * Have prior renal transplant, current renal dialysis, or moderate to 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) * History of alcohol, drug, or chemical abuse within the 6 months prior to screening * Neuropathy or other painful, chronic conditions that might interfere with pain evaluation * Body weight of \>150 kg * HBsAg positive and/or Anti-HBc with sign of current infection.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-center, two-part, randomized, double-blind, placebo-controlled study 4 and 12 weeks study with repeated doses of AP1189', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 420, 'type': 'ESTIMATED'}}

2023-01-09