A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
NCT ID: NCT06928142
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-04-23
2027-06-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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400 mg Sibeprenlimab
Sibeprenlimab
400 mg administered SC Q4 weeks
Placebo
Placebo
Administered SC Q4 weeks
Interventions
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Sibeprenlimab
400 mg administered SC Q4 weeks
Placebo
Administered SC Q4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
75 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Kirk Kerkorian School of Medicine UNLV
Las Vegas, Nevada, 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
Ruppert Health Center
Toledo, Ohio, United States
STAT Research
Vandalia, Ohio, United States
Toyos Clinic-Memphis
Nashville, Tennessee, 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
Mediadvance Clinical S.A.P.I. de C.V
San Felipe, Chihuahua, Mexico
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco, Mexico
PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS
Zapopan, Jalisco, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, Mexico City, Mexico
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, Poland
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, Poland
Prywatna Praktyka Lekarska Pawel Hrycaj
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
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher
Warsaw, 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
Countries
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Central Contacts
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Other Identifiers
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417-201-00042
Identifier Type: -
Identifier Source: org_study_id
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