RECRUITING

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

Description

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.

Conditions

Sjogren Disease
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Related Conditions:

Sjogren Disease

Study Overview

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Study Details

Study overview

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.

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's

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

Condition
Sjogren Disease
Intervention / Treatment

-

Contacts and Locations

Riverside

Medvin Clinical Research - Riverside, Riverside, California, United States, 92508

Tujunga

Medvin Clinical Research - Tujunga, Tujunga, California, United States, 91042

Brandon

Bay Area Arthritis and Osteoporosis, Brandon, Florida, United States, 33511

Clearwater

Clinical Research of West Florida Inc, Clearwater, Florida, United States, 33765

Fort Lauderdale

GNP Research - Florida, Fort Lauderdale, Florida, United States, 33309

Tampa

Vantage Clinical Trials - Tampa - ClinEdge - PPDS, Tampa, Florida, United States, 33614

Rockford

OrthoIllinois, LTD, Rockford, Illinois, United States, 61114

Baton Rouge

Ochsner Clinic Foundation, Baton Rouge, Louisiana, United States, 70836

Boston

Tufts University School of Dental Medicine, Boston, Massachusetts, United States, 02111

Albuquerque

Albuquerque Center for Rheumatology, Albuquerque, New Mexico, United States, 87102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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).

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Otsuka Pharmaceutical Development & Commercialization, Inc.,

Study Record Dates

2027-06-04