Clinical Study of Divozilimab in Patients With Systemic Scleroderma

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05726630

Acronym

LIBERIUS

Enrollment

152

Registered

2023-02-14

Start date

2022-12-26

Completion date

2027-02-01

Last updated

2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Scleroderma

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. 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.

Interventions

DRUGDivozilimab

anti CD20 monoclonal antibody

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Change in Forced Vital Capacity (FVC) from baseline	week 48	FVC (Forced Vital Capacity) desribes pulmonary function. FVC will be assessed using a spirometer.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026