Clinical Study of Divozilimab in Patients With Systemic Scleroderma (LIBERIUS)

Biocad

Status and phase: Active, not recruiting; Phase 3

Conditions: Systemic Scleroderma

Treatments: Drug: Divozilimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05726630

BCD-132-5

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• For subjects aged ≥16 years: a diagnosis of systemic scleroderma according to the ACR/EULAR 2013 criteria; a modified Rodnan skin score (mRSS) ≥10 and ≤20
• For subjects aged ≥14 and <16 years: a diagnosis of systemic scleroderma according to the PRES/ACR/EULAR 2007 criteria.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 2 patient groups, including a placebo group

Divozilimab

Experimental group

Treatment:

Drug: Divozilimab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo