Clinical Study of Divozilimab in Patients With Systemic Scleroderma

Phase 3

Active, not recruiting

• Conditions: Systemic Scleroderma
• Interventions: Drug: Divozilimab; Drug: Placebo

• Registration Number: NCT05726630
• Lead Sponsor: Biocad

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-26
• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-14
• Primary Completion: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Divozilimab	Divozilimab	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in the modified Rodnan Skin Score (mRSS) from baseline	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.

Secondary Outcome Measures

Name	Time	Method
Change in the modified Rodnan Skin Score (mRSS) from baseline	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.
Change in the FVC (forced vital capacity) from baseline	week 48	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	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.

Trial Locations

Locations (3)

Chelyabinsk Regional Clinical hospital; 🇷🇺 Chelyabinsk, Russian Federation

Clinical Rheumatology Hospital №25; 🇷🇺 Saint Petersburg, Russian Federation

North-Western state Medical University named after I.I. Mechnikov; 🇷🇺 Saint Petersburg, Russian Federation