Back to resultsClinical Study of Divozilimab in Patients With Systemic Scleroderma (LIBERIUS)
Primary Purpose
Systemic Scleroderma
Status
Recruiting
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Divozilimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Scleroderma
Eligibility 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.
Sites / Locations
- Chelyabinsk Regional Clinical hospitalRecruiting
- Clinical Rheumatology Hospital №25Recruiting
- North-Western state Medical University named after I.I. MechnikovRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Divozilimab
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05726630
Brief Title
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
Acronym
LIBERIUS
Official Title
A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 26, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Scleroderma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Divozilimab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Divozilimab
Intervention Description
anti CD20 monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in the modified Rodnan Skin Score (mRSS) from baseline
Description
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
Secondary Outcome Measure Information:
Title
Change in the modified Rodnan Skin Score (mRSS) from baseline
Description
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
Title
Change in the FVC (forced vital capacity) from baseline
Description
Forced vital capacity is the amount of air that can be forcibly exhaled after the deepest possible breath.
Time Frame
week 48
Title
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Chelyabinsk Regional Clinical hospital
City
Chelyabinsk
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Nesmeianova, PhD
Phone
+73517493727
Email
chelokb@mail.ru
Facility Name
Clinical Rheumatology Hospital №25
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inna Gaidukova
Phone
+7 (812) 670 30 90
Email
b25@zdrav.spb.ru
Facility Name
North-Western state Medical University named after I.I. Mechnikov
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vadim Mazurov
Phone
+7 (812) 303 50 00
Email
rectorat@szgmu.ru
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
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