About RESOLVE
The RESOLVE study (SynAct-CS006) 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.
In Part A approximately 120 randomized patients will be treated with either 60 mg AP1189, 80 mg AP1189, 100 mg AP1189 or placebo once daily for 4 weeks as add-on treatment to stable MTX treatment. Part A will conclude with an unblinded assessment for risk/benefit and a recommendation for dose selection for Part B.
In Part B patients will be randomized into groups of equal size evaluating 2-3 doses of AP1189 versus placebo, all doses will be administered once daily for 12 weeks as add-on treatment to stable MTX treatment. The proposed sample size per dose group/placebo group is 75 patients, by which the total study population of Part B may be either 225 or 300 patients, depending on the number of dose groups of AP1189 selected for evaluation based on Part A.
The objectives of the two-part study are to evaluate the efficacy and safety of multiple doses of AP1189 when combined with MTX in DMARD-IR patients. The safety of AP1189 will be assessed by comparing AP1189 against placebo for adverse events, physical examinations, vital sign measurements, ECG, and clinical laboratory testing (hematology, chemistry, and urinalysis). The primary efficacy endpoint is the effect of AP1189 compared to placebo evaluated by the ACR20 response. The effect will additionally be evaluated by ACR50, ACR70, CDAI, DAS-28, CRP, the need for rescue medication, inflammatory and collagen turnover biomarkers, HAQ-DI and FACIT-Fatigue. In Part B changes in imaging parameters reflecting joint inflammation (DCE-MRI) from Baseline to Week 12 will be evaluated in a subgroup of patients.