RECRUITING

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

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Conditions

Sjogren DiseaseSibeprenlimabAutoimmune DiseasesImmune System DiseasesDry MouthDry EyesSalivary Gland DisordersLacrimal Gland DisordersImmunoglobulin GEnVISage

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-23
Study Completion:2027-06-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06928142

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with Sjögren's disease.
  2. * ESSDAI score (which measures disease activity) must be 5 or higher.
  3. * Salivary flow rate must be at least 0.05 mL/min.
  4. * Serum IgG level must be higher than 900 mg/dL.
  5. * Must be able to communicate well with the investigator and agree to follow the trial requirements.
  6. * Participants can continue certain medications (hydroxychloroquine, methotrexate, leflunomide, or azathioprine) if they have been on a stable dose for at least 30 days.
  7. * Corticosteroid dose must be stable and no more than 10 mg/day for at least 30 days.
  8. * Test positive for anti-Ro52 and/or anti-Ro60 antibodies.
  1. * Another active autoimmune rheumatic disease.
  2. * Prior use of B-cell depleting therapy or prohibited immunosuppressants.
  3. * Significant comorbidities including uncontrolled type 2 diabetes, malignancy, and chronic and/or acute infections.
  4. * Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

Contacts and Locations

Study Contact

Otsuka Call Center
CONTACT
844-687-8522
Otsuka-ProfessionalServices@otsuka-us.com

Study Locations (Sites)

Medvin Clinical Research - Riverside
Riverside, California, 92508
United States
Medvin Clinical Research - Tujunga
Tujunga, California, 91042
United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
United States
Clinical Research of West Florida Inc
Clearwater, Florida, 33765
United States
GNP Research - Florida
Fort Lauderdale, Florida, 33309
United States
Vantage Clinical Trials - Tampa - ClinEdge - PPDS
Tampa, Florida, 33614
United States
OrthoIllinois, LTD
Rockford, Illinois, 61114
United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70836
United States
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102
United States
DJL Clinical Research PLLC
Charlotte, North Carolina, 28211
United States
STAT Research
Dayton, Ohio, 45402
United States
Tekton Research, LLC
Austin, Texas, 78745
United States
Accurate Clinical Research - Houston
Houston, Texas, 77034
United States
Prolato Clinical Research Center
Houston, Texas, 77054
United States
R & H Clinical Research
Katy, Texas, 77450
United States
Accurate Clinical Management, LLC
Kingwood, Texas, 77339
United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
United States

Collaborators and Investigators

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-23
Study Completion Date2027-06-04

Study Record Updates

Study Start Date2025-04-23
Study Completion Date2027-06-04

Terms related to this study

Keywords Provided by Researchers

  • Sibeprenlimab
  • Autoimmune Diseases
  • Immune System Diseases
  • Dry Mouth
  • Dry Eyes
  • Salivary Gland Disorders
  • Lacrimal Gland Disorders
  • Immunoglobulin G
  • EnVISage

Additional Relevant MeSH Terms

  • Sjogren Disease