Clinical Study of Divozilimab in Patients With Systemic Scleroderma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-26

Study Completion Date

2027-02-01

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.

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Detailed Description

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Conditions

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Systemic Scleroderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Divozilimab

Group Type EXPERIMENTAL

Divozilimab

Intervention Type DRUG

anti CD20 monoclonal antibody

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Divozilimab

anti CD20 monoclonal antibody

Intervention Type DRUG

Placebo

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No