Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05726630

Clinical Study 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.

The study will include patients of either sex aged ≥16 years with systemic scleroderma according to the ACR/EULAR 2013 criteria, with a modified Rodnan skin score (mRSS) ≥10 and ≤20 , as well as patients of either sex aged ≥14 and <16 years with systemic scleroderma according to the PRES/ACR/EULAR 2007 criteria. In patients having signs of ILD, the Forced Vital Capacity (FVC) should be at least 40 % of the due value. Subjects aged ≥18 years will be randomized to divozilimab or placebo group. Subjects aged <18 years (not less than 16) will receive divozilimab.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Systemic Scleroderma Connective Tissue Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chelyabinsk Regional Clinical hospital, Chelyabinsk, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For subjects aged ≥16 years: a diagnosis of systemic scleroderma according to the ACR/EULAR 2013 criteria; a modified Rodnan skin score (mRSS) ≥10 and ≤20
  • For subjects aged ≥14 and <16 years: a diagnosis of systemic scleroderma according to the PRES/ACR/EULAR 2007 criteria.
  • 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.

Treatment and study plan

Divozilimab

Drug

anti CD20 monoclonal antibody

Placebo

Drug

Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Forced Vital Capacity (FVC) from baseline

    Time frame: week 48

    FVC (Forced Vital Capacity) desribes pulmonary function. FVC will be assessed using a spirometer.

Sponsors and collaborators

Lead sponsor

Biocad

Industry

Registry information

Official study title

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

Acronym: LIBERIUS

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Feb 14, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.