Clinical Research Directory
Browse clinical research sites, groups, and studies.
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
Sponsor: Biocad
Summary
The study is a randomized, double-blind, placebo-controlled clinical study of the efficacy and safety of divozilimab in patients with systemic scleroderma.The study will enroll adult patients of both sexes diagnosed with active systemic scleroderma according to the ACR/EULAR 2013 criteria with a modified Rodnan skin score (mRSS) of 10 to 20. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects will be randomized to divozilimab or placebo group.
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2022-12-26
Completion Date
2027-02-01
Last Updated
2025-06-13
Healthy Volunteers
No
Conditions
Interventions
Divozilimab
anti CD20 monoclonal antibody
Placebo
Placebo
Locations (3)
Chelyabinsk Regional Clinical hospital
Chelyabinsk, Russia
Clinical Rheumatology Hospital №25
Saint Petersburg, Russia
North-Western state Medical University named after I.I. Mechnikov
Saint Petersburg, Russia