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Clinical Trials in Spain / NCT06928142
Active, not recruiting Phase 2

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

NCT06928142 · tracked via the Priya Life Science Spain tracker
Phase
Phase 2
Started
2025-04-23
Last updated
2026-03-18

Condition(s) studied

Sjogren Disease

Investigational drug(s) / intervention(s)

Sibeprenlimab →Placebo

Sibeprenlimab: 400 mg administered SC Q4 weeks

Placebo: Administered SC Q4 weeks

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (64)

FacilityCityRegionStatus
Medvin Clinical Research - Riverside Riverside California
Medvin Clinical Research - Tujunga Tujunga California
Bay Area Arthritis and Osteoporosis Brandon Florida
Clinical Research of West Florida Inc Clearwater Florida
GNP Research - Florida Cooper City Florida
Vantage Clinical Trials - Tampa - ClinEdge - PPDS Tampa Florida
OrthoIllinois, LTD Rockford Illinois
Arnold Arthritis and Rheumatology Skokie Illinois
Ochsner Clinic Foundation Baton Rouge Louisiana
Tufts University School of Dental Medicine Boston Massachusetts
Albuquerque Center for Rheumatology Albuquerque New Mexico
Bradenton Research Center Inc The Bronx New York
DJL Clinical Research PLLC Charlotte North Carolina
STAT Research Vandalia Ohio
Allen Arthritis Allen Texas
Tekton Research, LLC Austin Texas
Advanced Rheumatology of Houston Houston Texas
Accurate Clinical Research - Houston Houston Texas
Accurate Clinical Management, LLC Katy Texas
R & H Clinical Research Katy Texas
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS Ciudad Autónoma de Buenos Aires Buenos Aires
Instituto CER S.A. Quilmes Buenos Aires
Instituto Médico de la Fundación Estudios Clínicos Rosario Santa Fe Province
Clínica Mayo de U.M.C.B. S.R.L San Miguel de Tucumán Tucumán Province
Centro de Investigaciones Médicas Tucumán - PPDS San Miguel de Tucumán Tucumán Province
DOM Centro de Reumatología Buenos Aires Argentina
Expertia S.A- Mautalén Salud e Investigación Buenos Aires Argentina
Maffei Centro Médico Buenos Aires Argentina
Aprillus Asistencia e Investigacion de Arcis Salud SRL Buenos Aires Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan San Juan Argentina
Medical Center Medconsult Pleven OOD Pleven Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-15 A Vassil Aprilov Boulevard Plovdiv Bulgaria
Medical Center Excelsior OOD - PPDS Sofia Bulgaria
Diagnostic- Consultative Center Convex EOOD Sofia Bulgaria
Medical Center- Nova Clinic Varna Bulgaria
Universitätsklinikum Freiburg Freiburg im Breisgau Baden-Wurttemberg
Universitätsklinikum Köln Cologne North Rhine-Westphalia
Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh Hamburg Germany
Medicover München Ost MVZ München Germany
Olympion General Clinic Pátrai Achaïa

+ 24 more sites — see the full list on the official registry below.

More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06928142 on ClinicalTrials.gov ↗ ← All trials in Spain