Sibeprenlimab for Sjögren's Syndrome

Recruiting at 17 trial locations

Overseen By 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 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 in participants with Sjögren's disease.

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.

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

I tested positive for anti-Ro52 or anti-Ro60 antibodies.

Serum IgG level must be higher than 900 mg/dL

I have been diagnosed with Sjögren's disease.

Exclusion Criteria

Another active autoimmune rheumatic disease

I have used B-cell depleting therapy or certain immunosuppressants.

Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9)

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