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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
152
anti CD20 monoclonal antibody
Placebo
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
Change in the modified Rodnan Skin Score (mRSS) from baseline
The modified Rodnan Skin Score (mRSS) describes the thickness of skin in 17 anatomic areas rated from 0 to 3, where 3 indicates the most severe thickening.
Time frame: week 24
Change in the modified Rodnan Skin Score (mRSS) from baseline
The modified Rodnan Skin Score (mRSS) describes the thickness of skin in 17 anatomic areas rated from 0 to 3, where 3 indicates the most severe thickening.
Time frame: week 48
Change in the FVC (forced vital capacity) from baseline
Forced vital capacity is the amount of air that can be forcibly exhaled after the deepest possible breath.
Time frame: week 48
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) describes the patient's self-assessed degree of disability. HAQ-DI comprises 8 categories of questions rated from 0 to 3, where 3 indicates the worst degree of disability.
Time frame: week 48
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