LIBERIUS: Clinical Study of Divozilimab in Patients With Systemic Scleroderma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Divozilimab
|
Drug: Divozilimab
anti CD20 monoclonal antibody
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Change in the modified Rodnan Skin Score (mRSS) from baseline [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 Outcome Measures
- Change in the modified Rodnan Skin Score (mRSS) from baseline [week 48]
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.
- Change in the FVC (forced vital capacity) from baseline [week 48]
Forced vital capacity is the amount of air that can be forcibly exhaled after the deepest possible breath.
- Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline [week 48]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of "systemic scleroderma" in accordance with the ACR/EULAR 2013 classification.
-
Modified Rodnan skin score (mRSS) from 10 to 20.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chelyabinsk Regional Clinical hospital | Chelyabinsk | Russian Federation | ||
| 2 | Clinical Rheumatology Hospital №25 | Saint Petersburg | Russian Federation | ||
| 3 | North-Western state Medical University named after I.I. Mechnikov | Saint Petersburg | Russian Federation |
Sponsors and Collaborators
- Biocad
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BCD-132-5