A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)

Condition studied

Rheumatoid arthritis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in DAS28-CRP between Baseline and Week 12. The primary comparison will be between placebo and the highest dose group.

Endpoint detail

Incidence and severity of TEAEs, including SAEs., Incidence and severity of AEs of special interest (AESIs)., Incidence and severity of SUSARs., Clinically significant abnormalities and change from Baseline in 12-lead ECG (including QTcF)., Clinically significant abnormalities and change from Baseline in vital signs., Change from Baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis)., Percentage of participants reaching remission and low disease activity as defined by DAS28-CRP at Week 12 and at Week 24., Percentage of participants reaching ACR20/ACR50/ACR70 at Week 12 and at Week 24., Change from Baseline to Week 12 and to Week 24 in swollen joint count, tender joint count, physician’s global assessment of disease activity (VAS), serum CRP levels, SDAI and CDAI., Change from Baseline to Week 12 and to Week 24 of participant’s global assessment of disease activity (VAS), participant’s global assessment of arthritis pain (VAS), participant’s assessment of physical function (HAQ-DI), SF-36, and FACIT-Fatigue Questionnaire., Assess dose response relationship on Disease Activity Scores., Plasma drug and drug metabolite concentrations, will include but not be limited to: Cmax, Tmax, AUC0-last, AUC0-inf, t½, λz, CL/F, Vz/F, and CLR following single oral dosing.