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Active Not Recruiting
NCT05726630
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
Conditions: Systemic Scleroderma
Sex: All
Ages: 16 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 152
Sponsor: Biocad
Location: Chelyabinsk Regional Clinical hospital Chelyabinsk
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.
The study will include patients of either sex aged ≥16 years with systemic scleroderma according to the ACR/EULAR 2013 criteria, with a modified Rodnan skin score (mRSS) ≥10 and ≤20 , as well as patients of either sex aged ≥14 and \
Eligibility Criteria
Inclusion Criteria:
* For subjects aged ≥16 years: a diagnosis of systemic scleroderma according to the ACR/EULAR 2013 criteria; a modified Rodnan skin score (mRSS) ≥10 and ≤20
* For subjects aged ≥14 and \
Source: ClinicalTrials.gov (NCT05726630). StuddyBuddy aggregates publicly available trial information.
