Clinical Study of Divozilimab in Patients With Systemic Scleroderma
LIBERIUS
A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
1 other identifier
interventional
152
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2022
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 26, 2022
CompletedFirst Submitted
Initial submission to the registry
February 3, 2023
CompletedFirst Posted
Study publicly available on registry
February 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedJune 13, 2025
November 1, 2024
1.8 years
February 3, 2023
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
week 24
Secondary Outcomes (3)
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
Study Arms (2)
Divozilimab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biocadlead
Study Sites (3)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2023
First Posted
February 14, 2023
Study Start
December 26, 2022
Primary Completion
October 1, 2024
Study Completion (Estimated)
February 1, 2027
Last Updated
June 13, 2025
Record last verified: 2024-11