This Phase 2b, multicenter, double-blind, placebo-controlled, randomized withdrawal study is designed to assess the efficacy and safety of IMVT-1402 in adult participants with active, difficult-to-treat, anti-citrullinated protein autoantibody (ACPA) positive rheumatoid arthritis (RA).
The primary objective is to evaluate the effects of IMVT-1402 compared to placebo, as measured by the American College of Rheumatology 20% (ACR20) response at Week 28. The total duration of study participation is expected to be up to 86 weeks for an individual participant with 16 weeks of open-label treatment, 12 weeks of blinded randomized treatment, and 48 weeks of optional long-term extension treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
Proportion of participants who maintain ACR20 response at Week 28
Time frame: Week 28
Change in Clinical Disease Activity Index (CDAI) score from Week 16 to Week 28
Time frame: Week 16 to Week 28
Change in Simplified Disease Activity Index (SDAI) score from Week 16 to Week 28
Time frame: Week 16 to Week 28
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Site Number - 1018
Mesa, Arizona, United States
Site Number - 1019
Sun City, Arizona, United States
Site Number - 1022
Covina, California, United States
Site Number - 1028
San Leandro, California, United States
Site Number - 1024
Temecula, California, United States
Site Number - 1033
Tujunga, California, United States
Site Number - 1023
Whittier, California, United States
Site Number - 1020
Denver, Colorado, United States
Site Number - 1015
Jupiter, Florida, United States
Site Number - 1002
Miami, Florida, United States
...and 73 more locations