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Clinical Study of Divozilimab in Patients With Systemic Scleroderma

NCT05726630 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-06-10

No results posted yet for this study

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.

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.

Conditions

  • Systemic Scleroderma

Interventions

DRUG

Divozilimab

anti CD20 monoclonal antibody

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-26
Primary Completion
2024-10-01
Completion
2027-02-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05726630 on ClinicalTrials.gov