NCT05726630Active, not recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 152 (actual)
- First submitted
- 3 Feb 2023
- Start date
- 26 Dec 2022
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Biocad
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT05726630
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 152
- From 26 Dec 2022 to the primary completion date, 1 Oct 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Silicone implants/protheses.
Other illness
- Digital ulcers with signs of infection or indications for any amputation.
- History of threatment with anti-CD20 monoclonal antibodies.
Other
- Induced scleroderma.
- Blood biochemistry or hematological abnormalities at screening.
- FEV1/FVC \< 0.7 and FEV1\< 50 % at screening.
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chelyabinsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| North-Western State Medical University named after I.I. Mechnikov Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Clinical Rheumatology Hospital №25 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.