Clinical Study of Divozilimab in Patients With Systemic Scleroderma

Study Overview
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Brief Summary
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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.

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

Conditions
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Systemic Scleroderma

Intervention / Treatment
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* Drug: Divozilimab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Divozilimab<br> | Drug: Divozilimab<br>* anti CD20 monoclonal antibody<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |