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ACTIVE NOT RECRUITING
NCT06928142
PHASE2

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

83

Start Date

2025-04-23

Completion Date

2027-06-04

Last Updated

2026-03-18

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Sibeprenlimab

400 mg administered SC Q4 weeks

OTHER

Placebo

Administered SC Q4 weeks

Locations (64)

Medvin Clinical Research - Riverside

Riverside, California, United States

Medvin Clinical Research - Tujunga

Tujunga, California, United States

Bay Area Arthritis and Osteoporosis

Brandon, Florida, United States

Clinical Research of West Florida Inc

Clearwater, Florida, United States

GNP Research - Florida

Cooper City, Florida, United States

Vantage Clinical Trials - Tampa - ClinEdge - PPDS

Tampa, Florida, United States

OrthoIllinois, LTD

Rockford, Illinois, United States

Arnold Arthritis and Rheumatology

Skokie, Illinois, United States

Ochsner Clinic Foundation

Baton Rouge, Louisiana, United States

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, United States

Bradenton Research Center Inc

The Bronx, New York, United States

DJL Clinical Research PLLC

Charlotte, North Carolina, United States

STAT Research

Vandalia, Ohio, United States

Allen Arthritis

Allen, Texas, United States

Tekton Research, LLC

Austin, Texas, United States

Advanced Rheumatology of Houston

Houston, Texas, United States

Accurate Clinical Research - Houston

Houston, Texas, United States

Accurate Clinical Management, LLC

Katy, Texas, United States

R & H Clinical Research

Katy, Texas, United States

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto CER S.A.

Quilmes, Buenos Aires, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, Argentina

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina

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, Germany

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

Hamburg, Germany

Medicover München Ost MVZ

München, Germany

Olympion General Clinic

Pátrai, Achaïa, Greece

Laiko General Hospital of Athens (Site 1)

Athens, Attica, Greece

Laiko General Hospital of Athens (Site 2)

Athens, Attica, Greece

General Hospital ''Asklepieio Voulas''

Voula, Attica, Greece

Twoja Przychodnia PCM

Poznan, Greater Poland Voivodeship, Poland

Med-Polonia Sp. z o.o.

Poznan, Greater Poland Voivodeship, Poland

Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3

Wroclaw, Lower Silesian Voivodeship, Poland

ETG Siedlce - PPDS

Siedlce, Masovian Voivodeship, Poland

Klinika Reuma Park sp . zoo Sp.k.

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne K2J2 - Wołomin

Wołomin, Masovian Voivodeship, Poland

MICS Centrum Medyczne Bydgoszcz

Bydgoszcz, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, Poland

NZOZ Holsamed - Oddzial Libero

Katowice, Poland

Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4

Lublin, Poland

Pratia Poznan - PPDS

Poznan, Poland

ETG Warszawa - PPDS

Warsaw, Poland

Policlinica SelfMed Clinique

Timișoara, Timiș County, Romania

Sf.Maria Clinical Hospital

Bucharest, Romania

Colentina Clinical Hospital

Bucharest, Romania

Cluj-Napoca Emergency Clinical County Hospital

Cluj-Napoca, Romania

Medart Cliniq

Râmnicu Vâlcea, Romania

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital General Universitari de Castello

Castelló, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital de Torrevieja

Torrevieja, Spain