Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
Summary
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of
abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing
non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be
randomized 1:1 to receive either abatacept 125 mg or placebo administered by subcutaneous
injection once a week. Participants will continue on study treatment for a minimum of 12
months unless they experience a disease relapse or disease flare.
Participants who experience a non-severe disease relapse, non-severe disease worsening, or
who have not achieved remission by month 6 will have the option of entering an open-label
trial period whereby they would receive open-label abatacept.
Phase:
Phase 3
Details
Lead Sponsor:
University of South Florida
Collaborators:
Bristol-Myers Squibb National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health (NIH) The Cleveland Clinic University of Pennsylvania