Sibeprenlimab for Sjögren's Syndrome

(EnVISage Trial)

Recruiting at 40 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Must not be taking: B-cell depleting therapy

Disqualifiers: Other active autoimmune disease, Uncontrolled diabetes, Malignancy, others

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

Compensation: Varies

Number of Visits: 10 visits

Duration: 28 weeks

80 Participants Needed

Trial Summary

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.

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. Before making any changes to your medications, please speak with the study team.

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

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.

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.

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 you often feel like your mouth is very dry, even when you drink enough water?

Do your eyes often feel dry, gritty, burning, or irritated?

Do you regularly have joint pain, stiffness (especially in the morning), or swollen joints?

Exclusion Criteria

Have you been diagnosed with an autoimmune condition (other than Sjogren’s) that is currently active or being treated?

In the past 4 months, have you taken any medications that suppress your immune system?

Has the patient taken any B-cell depleting therapy within the last 7 months?

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

24 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

24 weeks