Trials / Active Not Recruiting
Active Not RecruitingNCT05726630
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Divozilimab | anti CD20 monoclonal antibody |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2022-12-26
- Primary completion
- 2024-10-01
- Completion
- 2027-02-01
- First posted
- 2023-02-14
- Last updated
- 2025-06-13
Locations
3 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05726630. Inclusion in this directory is not an endorsement.