A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
Overview
- Phase
- Phase 3
- Intervention
- Divozilimab
- Conditions
- Systemic Scleroderma
- Sponsor
- Biocad
- Enrollment
- 152
- Locations
- 3
- Primary Endpoint
- Change in the modified Rodnan Skin Score (mRSS) from baseline
- Status
- Active, Not Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of "systemic scleroderma" in accordance with the ACR/EULAR 2013 classification.
- •Modified Rodnan skin score (mRSS) from 10 to
- •FVC ≥ 40 % of the due value.
Exclusion Criteria
- •Induced scleroderma.
- •Silicone implants/protheses.
- •Digital ulcers with signs of infection or indications for any amputation.
- •Blood biochemistry or hematological abnormalities at screening.
- •FEV1/FVC \< 0.7 and FEV1\< 50 % at screening.
- •History of threatment with anti-CD20 monoclonal antibodies.
Arms & Interventions
Divozilimab
Intervention: Divozilimab
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change in the modified Rodnan Skin Score (mRSS) from baseline
Time Frame: week 24
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.
Secondary Outcomes
- Change in the modified Rodnan Skin Score (mRSS) from baseline(week 48)
- Change in the FVC (forced vital capacity) from baseline(week 48)
- Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline(week 48)