Diagnostics And Consultation Center Convex Ltd.
Sofia, Bulgaria
Not recruitingSjogren's syndrome
Title: Study of Sibeprenlimab Treatment for Adults with Sjögren's Disease Using Subcutaneous Injections
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial focuses on evaluating a new treatment for Sjögren's Disease, an autoimmune condition that primarily affects the body's moisture-producing glands, causing symptoms like dry eyes and dry mouth. The study will test a medication called sibeprenlimab (also known as VIS649) given as an injection under the skin, compared to a placebo, in addition to patients' regular treatments.
The purpose of this research is to determine how well sibeprenlimab works in treating Sjögren's Disease symptoms compared to placebo after 28 weeks of treatment. During the study, participants will receive either sibeprenlimab or placebo through subcutaneous injections. The maximum single dose will be 400 mg, with treatment continuing for up to 52 weeks.
Throughout the study, researchers will monitor various aspects of the disease, including changes in tear and saliva production, fatigue levels, and overall disease activity. The study will also track how well participants tolerate the medication by monitoring their health and any side effects that may occur. Participants may continue taking certain background medications they were already using, such as hydroxychloroquine, methotrexate, leflunomide, or azathioprine, as long as their doses have been stable.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
13 criteria
- Must sign an informed consent form before participating in the study
- Age must be between 18 and 75 years
- Must meet the 2016 ACR/EULAR criteria for Sjögren's disease diagnosis
- Must test positive for anti-Ro52 and/or anti-Ro60 antibodies during screening (these are specific proteins in blood that indicate immune system activity)
- Must have an ESSDAI score of 5 or higher during screening (ESSDAI measures disease activity, excluding lung and nervous system symptoms)
- Must have a stimulated saliva flow rate of at least 0.05 mL per minute during screening
- Must have blood IgG levels above 900 mg/dL (IgG is an antibody that helps fight infections)
- If taking corticosteroids, must be on a stable dose of 10 mg or less per day of prednisone/prednisolone for at least 30 days before study start
- May be taking certain medications if on stable doses for at least 30 days before study start:
- Hydroxychloroquine (up to 400 mg/day)
- Methotrexate (up to 25 mg/week)
- Leflunomide (up to 20 mg daily)
- Azathioprine (up to 150 mg/day)
- Must be able to communicate well with the study team and follow study requirements
Who cannot join the trial?
15 criteria
- People younger than 18 years old
- People with active tuberculosis (an infectious bacterial disease affecting the lungs)
- History of lymphoma (cancer of the lymphatic system) or other cancers in the past 5 years
- Severe or uncontrolled infections
- Current pregnancy or breastfeeding
- Significant heart, liver, or kidney disease
- Recent vaccination with live vaccines (within 30 days before study start)
- Treatment with other experimental medications within 3 months
- Known allergic reactions to similar medications
- Uncontrolled diabetes (high blood sugar levels)
- Active hepatitis B or C (viral infections affecting the liver)
- Presence of HIV infection (human immunodeficiency virus)
- Severe mental health conditions that could interfere with the study
- Drug or alcohol abuse within the past year
- Previous participation in a clinical trial within 30 days
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Responsive Spitalul Clinic Judetean De Urgenta Cluj
Cluj Napoca, RomaniaResponsive University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria
Trial locations
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Investigated drugs
Sibeprenlimab is an investigational medication administered by injection under the skin (subcutaneously) that is being studied for the treatment of Sjögren's Disease. It is designed to target specific components of the immune system that may be involved in causing inflammation and symptoms associated with Sjögren's Disease. This medication is being tested to see if it can help reduce disease activity and improve symptoms when added to patients' existing treatments.
What is already known about the treatment
Sibeprenlimab - A novel investigational biologic medication administered through subcutaneous injection, currently being studied in Phase 2 clinical trials for the treatment of Sjögren's disease, an autoimmune disorder. This monoclonal antibody is designed to target specific immune system components involved in the inflammatory processes characteristic of Sjögren's disease, with the aim of reducing disease activity as measured by the ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index). The medication represents a new therapeutic approach in autoimmune disease management, being evaluated for its efficacy and safety when used alongside standard background treatments.
Investigated diseases
Sjögren's syndrome - A chronic autoimmune disorder where the body's immune system attacks its own moisture-producing glands, particularly those that produce tears and saliva. The condition typically causes dry eyes and dry mouth, but can also affect other parts of the body including joints, muscles, and internal organs. People with Sjögren's syndrome often experience fatigue, joint pain, and swelling of the salivary glands. The condition can develop on its own (primary Sjögren's) or occur alongside other autoimmune disorders (secondary Sjögren's). Over time, the ongoing inflammation can lead to dysfunction of various organs and tissues.
Ongoing clinical trials in Sjogren's syndrome
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- Sponsor:Universitaetsklinikum Erlangen AöR
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- Disease:Systemic sclerodermaRheumatoid arthritis+2
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Study on the Effectiveness of CL-AD-MSC-002 Injections for Dry Mouth in Patients with Sjögren's Syndrome
InvestigationalNo placebo
- Disease:Sjogren's syndrome
- Substances:Cl-Ad-Msc-002
Countries:
Denmark
Denmark- Participants:18–64 years · 65+ years
- Substances:Cl-Ad-Msc-002
- Sponsor:Region Hovedstaden
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516295-14-00Protocol code417-201-00042Estimated enrolment84 patientsSponsorOtsuka Pharmaceutical Development & Commercialization Inc.
sourced from the EU Clinical Trials Register and site verification
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