Systemic SclerodermaPhase 3LIBERIUSNCT05726630
Clinical Study of Divozilimab in Patients With Systemic Scleroderma
A Phase 3 study testing Divozilimab in people with Systemic Scleroderma, run by Biocad at 3 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- Divozilimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 3 sitesRussia
- Study dates
- 26 Dec 2022to 1 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Russia3 sites
Chelyabinsk Regional Clinical hospital
Chelyabinsk
Clinical Rheumatology Hospital №25
Saint Petersburg
North-Western state Medical University named after I.I. Mechnikov
Saint Petersburg
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
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.
- Conditions
- Systemic Scleroderma
- Being tested
- Divozilimab, Placebo
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DivozilimabDrug
anti CD20 monoclonal antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Divozilimab | Experimental | Not described Receives: Drug: Divozilimab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the modified Rodnan Skin Score (mRSS) from baseline
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.
Measured: week 48
Secondary outcomes (1)
Change in Forced Vital Capacity (FVC) from baseline
FVC (Forced Vital Capacity) desribes pulmonary function. FVC will be assessed using a spirometer.
Measured: week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start26 Dec 2022
- Primary completion1 Oct 2024
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726630
- Sponsor's protocol ID
- BCD-132-5
- Acronym
- LIBERIUS
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Divozilimab in Patients With Systemic Scleroderma
- ClinicalTrials.gov ID
- NCT05726630
- Acronym / sponsor ID
- LIBERIUS / BCD-132-5
- Conditions
- Systemic Scleroderma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divozilimab | Experimental | Drug: Divozilimab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Divozilimabanti CD20 monoclonal antibody | Drug | Divozilimab |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in the modified Rodnan Skin Score (mRSS) from baseline
Time frame: 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.
1 secondary outcome
Change in Forced Vital Capacity (FVC) from baseline
Time frame: week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divozilimab in people with Systemic Scleroderma, run by Biocad at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the modified Rodnan Skin Score (mRSS) from baseline (time frame: week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.