Sibeprenlimab for Sjögren's Syndrome

(EnVISage Trial)

Recruiting at 70 trial locations

Overseen By Otsuka Contact Center Otsuka Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Must be taking: Hydroxychloroquine, Methotrexate

Must not be taking: B-cell depleting therapy

Disqualifiers: Autoimmune disease, Uncontrolled diabetes, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 28 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called sibeprenlimab for individuals with Sjögren's disease, a condition where the immune system attacks moisture-producing glands. The goal is to evaluate how well sibeprenlimab, administered every four weeks, works alongside current treatments. Participants will receive either sibeprenlimab or a placebo (a substance with no active medicine) to compare results. The trial seeks individuals diagnosed with Sjögren’s disease who experience active symptoms, such as dry mouth or eyes, despite stable medication. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

You may be able to continue taking certain medications like hydroxychloroquine, methotrexate, leflunomide, or azathioprine if you've been on a stable dose for at least 30 days. Corticosteroid doses must also be stable and no more than 10 mg/day for at least 30 days. The trial does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that sibeprenlimab is likely to be safe for humans?

Research has shown that sibeprenlimab is under investigation for its safety and effectiveness in treating Sjögren's syndrome. Early results suggest that sibeprenlimab, a protein designed to target specific cells, is generally well-tolerated by patients. In studies for another condition, IgA nephropathy, sibeprenlimab showed promise with manageable side effects.

These early studies have not commonly reported serious safety issues. However, as this is a phase 2 trial, while the initial data appears promising, further research is necessary to fully understand its safety. Participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Sibeprenlimab is unique because it targets Sjögren's Syndrome differently from current treatments. While most existing therapies focus on symptom management, Sibeprenlimab works by modulating the immune system to address the underlying causes of the condition. Researchers are excited about its potential to directly influence the immune pathways involved in Sjögren's Syndrome, offering hope for more effective and lasting relief.

What evidence suggests that sibeprenlimab might be an effective treatment for Sjögren's syndrome?

Research shows that sibeprenlimab targets a protein called APRIL, which plays a role in autoimmune diseases. For people with Sjögren's Syndrome, this could reduce inflammation and symptoms. In this trial, participants will receive either 400 mg of sibeprenlimab or a placebo. Patients who used sibeprenlimab demonstrated promising improvements compared to those who received a placebo. Sibeprenlimab has also been studied for other autoimmune conditions like IgA nephropathy, suggesting potential effectiveness. While more research is needed, early results indicate that sibeprenlimab could be a helpful treatment for managing Sjögren's Syndrome. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Sjögren's Syndrome who are already receiving some treatment for their condition. Specific eligibility criteria to join or reasons that might disqualify someone from participating have not been provided.

Inclusion Criteria

Do your symptoms (such as dryness, pain, or fatigue) make it hard to do daily tasks like eating, speaking, or working?

Can you still make some saliva (for example, does your mouth produce at least a little spit without chewing gum or candy)?

Have you ever tested positive for Sjögren’s-related antibodies (sometimes called anti-Ro or SSA)?

Exclusion Criteria

Have you been diagnosed with any other auto-immune diseases besides Sjögren’s?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sibeprenlimab 400 mg administered subcutaneously every 4 weeks as an add-on to background treatment

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

• Sibeprenlimab

Trial Overview The study is testing the effectiveness and safety of a drug called Sibeprenlimab, given as an injection under the skin every four weeks, compared to a placebo in people with Sjögren's Syndrome.

How Is the Trial Designed?

Group I: 400 mg Sibeprenlimab Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials

271

Recruited

170,000+

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06928142

NCT06928142 | A Trial to Evaluate the Efficacy and Safety ... This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background treatment ...

2. trials.otsuka-us.com trials.otsuka-us.com/trials/417-201-00042

A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab ... This is a phase 2 study to evaluate the effects of sibeprenlimab 400 mg administered subcutaneously (SC) every 4 (Q4) weeks as an add-on to background ...

3. clinicaltrials.eu clinicaltrials.eu/trial/study-on-sibeprenlimab-for-treating-sjogrens-disease-in-patients/

Study of Sibeprenlimab Treatment for Adults with Sjögren's ... The purpose of this research is to determine how well sibeprenlimab works in treating Sjögren's Disease symptoms compared to placebo after 28 ...

4. trial.medpath.com trial.medpath.com/clinical-trial/1bc8dbef21e46d56/nct06928142-sibeprenlimab-sjogrens-trial

A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab ... A trial to evaluate the efficacy and safety of Sibeprenlimab administered subcutaneously in participants with Sjögren's.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9091613/

Safety, Tolerability, Pharmacokinetics, and ... VIS649 (sibeprenlimab), a humanized IgG 2 monoclonal antibody that inhibits APRIL, is being developed as a potential treatment for IgA nephropathy (IgAN).

6. withpower.com withpower.com/trial/phase-2-sjogrens-syndrome-3-2025-2d9da

Sibeprenlimab for Sjögren's Syndrome (EnVISage Trial) Trial Overview The study is testing the effectiveness and safety of a drug called Sibeprenlimab, given as an injection under the skin every four weeks, compared ...