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Clinical Study of Divozilimab in Patients With Systemic Scleroderma

Study acronym: LIBERIUS
StatusActive, Not Recruiting
PhasePhase 3
SponsorBiocad
Started2022-12-26
View on ClinicalTrials.gov ↗

Amendment history

2026-06-08
Study Status, Study Description, Outcome Measures, Eligibility v3
Eligibility criteria+136 characters
Inclusion Criteria: DiagnosisFor subjects aged ≥16 years: a diagnosis of "systemic scleroderma" inaccording accordance withto the ACR/EULAR 2013 classification. Modifiedcriteria; a modified Rodnan skin score (mRSS) from≥10 10and ≤20 For subjects aged ≥14 and <16 years: a diagnosis of systemic scleroderma according to 20the PRES/ACR/EULAR 2007 criteria. FVC ≥ 40 % of the due value. Exclusion Criteria: Induced s [...]
Secondary endpoints3 to 1 entries
Change in theForced modifiedVital Rodnan Skin ScoreCapacity (mRSSFVC) from baseline Change in the FVC (forced vital capacity) from baseline Change in Health Assessment Questionnaire Disability Index (HAQ-DI) score from baseline
2025-06-10
Study Status v2
Completion date2026-02-01→2027-02-01
2024-11-13
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v1
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-08-01→confirmed 2024-10-01
Completion date2025-02-01→2026-02-01
Study sitesdetails revised at 3 of 3 sites
2023-02-03
Original filing
Biocad
26 trials monitored
See all monitored trials
Scleroderma
302 trials monitored
See 9 trials at risk
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.
Trial Details
NCT Number NCT05726630
Lead Sponsor Biocad
Conditions Systemic Scleroderma
Enrollment 152 participants
Start Date 2022-12-26
Primary Completion 2024-10-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-10