Clinical Study of Divozilimab in Patients With Systemic Scleroderma

Systemic Scleroderma Clinical Trial

— LIBERIUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726630
• Other study ID #: BCD-132-5
• Status: Recruiting
• Phase: Phase 3
• Start date: December 26, 2022
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2023
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: February 1, 2025
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic
• Systemic Scleroderma

Intervention

Drug:
• Divozilimab
anti CD20 monoclonal antibody
• Placebo
Placebo

Locations

Country	Name	City	State
Russian Federation	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

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	week 24
Secondary	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.	week 48
Secondary	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.	week 48
Secondary	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.	week 48