Clinical Study of Divozilimab in Patients With Systemic Scleroderma (LIBERIUS)

June 10, 2025 updated by: Biocad

A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Chelyabinsk Regional Clinical Hospital
      • Saint Petersburg, Russian Federation
        • North-Western State Medical University named after I.I. Mechnikov
      • Saint Petersburg, Russian Federation
        • Clinical Rheumatology Hospital №25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Divozilimab
Drug: Divozilimab
anti CD20 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the modified Rodnan Skin Score (mRSS) from baseline
Time Frame: 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.
week 48
Change in the FVC (forced vital capacity) from baseline
Time Frame: week 48
Forced vital capacity is the amount of air that can be forcibly exhaled after the deepest possible breath.
week 48
Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline
Time Frame: 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.
week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Actual)

October 1, 2024

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 3, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCD-132-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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