A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- Diagnosed with Sjögren's disease.

- ESSDAI score (which measures disease activity) must be 5 or higher.

- Salivary flow rate must be at least 0.05 mL/min.

- Serum IgG level must be higher than 900 mg/dL.

- Must be able to communicate well with the investigator and agree to follow the trial requirements.

- Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.

- Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.

- Test positive for anti-Ro52 and/or anti-Ro60 antibodies.

Key

Exclusion Criteria:

- Another active autoimmune rheumatic disease.

- Prior use of B-cell depleting therapy or prohibited immunosuppressants.

- Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06928142
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Otsuka Pharmaceutical Development & Commercialization, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Bulgaria, Germany, Greece, Mexico, Poland, Romania, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sjogren Disease

Additional Details

This is a multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study followed by an optional open-label extension to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q4 weeks as an add-on to background treatment in participants with Sjögren's disease. The primary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) scores at 28 weeks. The key secondary objective is to compare the effect of sibeprenlimab versus placebo added to background treatment on European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) at 28 weeks. Approximately 80 participants who have a diagnosis of Sjögren's disease according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria will be randomized with approximately 40 participants in the sibeprenlimab group and 40 participants in the placebo group.

Arms & Interventions

Arms

Experimental: 400 mg Sibeprenlimab

Placebo Comparator: Placebo

Interventions

Biological: - Sibeprenlimab

400 mg administered SC Q4 weeks

Other: - Placebo

Administered SC Q4 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Kirk Kerkorian School of Medicine UNLV, Birmingham 4049979, Alabama 4829764

Status

Not yet recruiting

Address

Kirk Kerkorian School of Medicine UNLV

Birmingham 4049979, Alabama 4829764, 35233

Site Contact

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