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

Last updated: March 16, 2026
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Collagen Vascular Diseases

Oral Facial Pain

Treatment

Sibeprenlimab

Placebo

Clinical Study ID

NCT06928142
417-201-00042
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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 trialrequirements.

  • Participants can continue certain medications (hydroxychloroquine, methotrexate,leflunomide, or azathioprine) if they have been on a stable dose for at least 30days.

  • 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

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, andchronic and/or acute infections.

  • Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

Study Design

Total Participants: 83
Treatment Group(s): 2
Primary Treatment: Sibeprenlimab
Phase: 2
Study Start date:
April 23, 2025
Estimated Completion Date:
June 04, 2027

Study Description

This is a multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study followed by an optional open-label extension to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q4 weeks as an add-on to background treatment in participants with Sjögren's disease.

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.

Connect with a study center

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
    Argentina

    Site Not Available

  • Instituto CER S.A.

    Quilmes, Buenos Aires B1878DVB
    Argentina

    Site Not Available

  • Instituto CER S.A.

    Quilmes 3429652, Buenos Aires 3435907 B1878DVB
    Argentina

    Site Not Available

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Santa Fe Province S2000DEJ
    Argentina

    Site Not Available

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario 3838583, Santa Fe Province 3836276 S2000DEJ
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucumán - PPDS

    San Miguel de Tucumán, Tucumán Province T4000
    Argentina

    Site Not Available

  • Clínica Mayo de U.M.C.B. S.R.L

    San Miguel de Tucumán, Tucumán Province T4000IHE
    Argentina

    Site Not Available

  • Centro de Investigaciones Médicas Tucumán - PPDS

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000
    Argentina

    Site Not Available

  • Clínica Mayo de U.M.C.B. S.R.L

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000IHE
    Argentina

    Active - Recruiting

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    Buenos Aires, C1406AGA
    Argentina

    Site Not Available

  • DOM Centro de Reumatología

    Buenos Aires, C1111AAH
    Argentina

    Site Not Available

  • Expertia S.A- Mautalén Salud e Investigación

    Buenos Aires, C1128AAF
    Argentina

    Site Not Available

  • Maffei Centro Médico

    Buenos Aires, C1180AAD
    Argentina

    Site Not Available

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    Buenos Aires 3435910, C1406AGA
    Argentina

    Site Not Available

  • DOM Centro de Reumatología

    Buenos Aires 3435910, C1111AAH
    Argentina

    Active - Recruiting

  • Expertia S.A- Mautalén Salud e Investigación

    Buenos Aires 3435910, C1128AAF
    Argentina

    Site Not Available

  • Maffei Centro Médico

    Buenos Aires 3435910, C1180AAD
    Argentina

    Active - Recruiting

  • Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

    San Juan, J5402
    Argentina

    Site Not Available

  • Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

    San Juan 3837213, J5402
    Argentina

    Site Not Available

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Medical Center Medconsult Pleven OOD

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-15 A Vassil Aprilov Boulevard

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-15 A Vassil Aprilov Boulevard

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Diagnostic- Consultative Center Convex EOOD

    Sofia 727011, 1680
    Bulgaria

    Site Not Available

  • Medical Center Excelsior OOD - PPDS

    Sofia 727011, 1407
    Bulgaria

    Active - Recruiting

  • Medical Center- Nova Clinic

    Varna, 9000
    Bulgaria

    Site Not Available

  • Medical Center- Nova Clinic

    Varna 726050, 9000
    Bulgaria

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg 79106
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau 2925177, Baden-Wurttemberg 2953481 79106
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia 50937
    Germany

    Site Not Available

  • Universitätsklinikum Köln

    Cologne 2886242, North Rhine-Westphalia 2861876 50937
    Germany

    Site Not Available

  • Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

    Hamburg, 22391
    Germany

    Site Not Available

  • Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

    Hamburg 2911298, 22391
    Germany

    Site Not Available

  • Medicover München Ost MVZ

    München, 81667
    Germany

    Site Not Available

  • Medicover München Ost MVZ

    München 2867711, 81667
    Germany

    Site Not Available

  • Olympion General Clinic

    Pátrai, Achaïa 264 43
    Greece

    Site Not Available

  • Olympion General Clinic

    Pátrai 255683, Achaïa 264 43
    Greece

    Site Not Available

  • Laiko General Hospital of Athens (Site 1)

    Athens, Attica 115 27
    Greece

    Site Not Available

  • Laiko General Hospital of Athens (Site 2)

    Athens, Attica 115 27
    Greece

    Site Not Available

  • General Hospital ''Asklepieio Voulas''

    Voula, Attica 166 73
    Greece

    Site Not Available

  • Laiko General Hospital of Athens (Site 1)

    Athens 264371, Attica 6692632 115 27
    Greece

    Active - Recruiting

  • Laiko General Hospital of Athens (Site 2)

    Athens 264371, Attica 6692632 115 27
    Greece

    Site Not Available

  • General Hospital ''Asklepieio Voulas''

    Voula 251780, Attica 6692632 166 73
    Greece

    Site Not Available

  • Mediadvance Clinical S.A.P.I. de C.V

    San Felipe 3987229, Chihuahua 4014336 31203
    Mexico

    Site Not Available

  • Centro de Estudios de Investigacion Basica Y Clinica SC

    Guadalajara 4005539, Jalisco 4004156 44690
    Mexico

    Site Not Available

  • PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS

    Zapopan 3979770, Jalisco 4004156 45030
    Mexico

    Site Not Available

  • Centro de Investigación y Tratamiento Reumatológico S.C

    Mexico City 3530597, Mexico City 3527646 31000
    Mexico

    Site Not Available

  • Med-Polonia Sp. z o.o.

    Poznan, Greater Poland Voivodeship 60-693
    Poland

    Site Not Available

  • Twoja Przychodnia PCM

    Poznan, Greater Poland Voivodeship 60-324
    Poland

    Site Not Available

  • Med-Polonia Sp. z o.o.

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-693
    Poland

    Site Not Available

  • Prywatna Praktyka Lekarska Pawel Hrycaj

    Poznan 3088171, Greater Poland Voivodeship 3337498 61-397
    Poland

    Site Not Available

  • Twoja Przychodnia PCM

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-324
    Poland

    Active - Recruiting

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

    Wroclaw, Lower Silesian Voivodeship 50-570
    Poland

    Site Not Available

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

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 50-570
    Poland

    Site Not Available

  • ETG Siedlce - PPDS

    Siedlce, Masovian Voivodeship 08-110
    Poland

    Site Not Available

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, Masovian Voivodeship 02-665
    Poland

    Site Not Available

  • Centrum Medyczne K2J2 - Wołomin

    Wołomin, Masovian Voivodeship 05-200
    Poland

    Site Not Available

  • ETG Siedlce - PPDS

    Siedlce 759412, Masovian Voivodeship 858787 08-110
    Poland

    Site Not Available

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw 756135, Masovian Voivodeship 858787 02-665
    Poland

    Active - Recruiting

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Dr hab. Med. Eleonory Reicher

    Warsaw 756135, Masovian Voivodeship 858787 02-637
    Poland

    Site Not Available

  • Centrum Medyczne K2J2 - Wołomin

    Wołomin 754800, Masovian Voivodeship 858787 05-200
    Poland

    Site Not Available

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065
    Poland

    Site Not Available

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz 3102014, 85-065
    Poland

    Active - Recruiting

  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

    Bydgoszcz 3102014, 85-168
    Poland

    Site Not Available

  • NZOZ Holsamed - Oddzial Libero

    Katowice, 40-600
    Poland

    Site Not Available

  • NZOZ Holsamed - Oddzial Libero

    Katowice 3096472, 40-600
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4

    Lublin, 20-607
    Poland

    Site Not Available

  • Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4

    Lublin 765876, 20-607
    Poland

    Site Not Available

  • Pratia Poznan - PPDS

    Poznan, 60-192
    Poland

    Site Not Available

  • Pratia Poznan - PPDS

    Poznan 3088171, 60-192
    Poland

    Active - Recruiting

  • ETG Warszawa - PPDS

    Warsaw, 02-677
    Poland

    Site Not Available

  • ETG Warszawa - PPDS

    Warsaw 756135, 02-677
    Poland

    Active - Recruiting

  • Policlinica SelfMed Clinique

    Timișoara, Timiș County 300133
    Romania

    Site Not Available

  • Policlinica SelfMed Clinique

    Timișoara 665087, Timiș County 665091 300133
    Romania

    Site Not Available

  • Colentina Clinical Hospital

    Bucharest, 20125
    Romania

    Site Not Available

  • Sf.Maria Clinical Hospital

    Bucharest, 11172
    Romania

    Site Not Available

  • Colentina Clinical Hospital

    Bucharest 683506, 20125
    Romania

    Site Not Available

  • Sf.Maria Clinical Hospital

    Bucharest 683506, 11172
    Romania

    Active - Recruiting

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca, 400006
    Romania

    Site Not Available

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca 681290, 400006
    Romania

    Site Not Available

  • Medart Cliniq

    Râmnicu Vâlcea, 240226
    Romania

    Site Not Available

  • Medart Cliniq

    Râmnicu Vâlcea 668872, 240226
    Romania

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario Marques de Valdecilla

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital General Universitari de Castello

    Castelló, 12004
    Spain

    Site Not Available

  • Hospital General Universitari de Castello

    Castelló 3125886, 12004
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal

    Madrid 3117735, 28034
    Spain

    Site Not Available

  • Hospital de Torrevieja

    Torrevieja, 3186
    Spain

    Site Not Available

  • Hospital de Torrevieja

    Torrevieja 2510253, 3186
    Spain

    Site Not Available

  • Kirk Kerkorian School of Medicine UNLV

    Birmingham 4049979, Alabama 4829764 35233
    United States

    Site Not Available

  • Medvin Clinical Research - Riverside

    Riverside, California 92508
    United States

    Site Not Available

  • Medvin Clinical Research - Tujunga

    Tujunga, California 91042
    United States

    Site Not Available

  • Medvin Clinical Research - Riverside

    Riverside 5387877, California 5332921 92508
    United States

    Site Not Available

  • Medvin Clinical Research - Tujunga

    Tujunga 5403767, California 5332921 91042
    United States

    Site Not Available

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinical Research of West Florida Inc

    Clearwater, Florida 33765
    United States

    Site Not Available

  • GNP Research - Florida

    Cooper City, Florida 33024
    United States

    Site Not Available

  • GNP Research - Florida

    Fort Lauderdale, Florida 33309
    United States

    Site Not Available

  • Vantage Clinical Trials - Tampa - ClinEdge - PPDS

    Tampa, Florida 33606
    United States

    Site Not Available

  • Bay Area Arthritis and Osteoporosis

    Brandon 4148757, Florida 4155751 33511
    United States

    Site Not Available

  • Clinical Research of West Florida Inc

    Clearwater 4151316, Florida 4155751 33765
    United States

    Site Not Available

  • GNP Research - Florida

    Cooper City 4151824, Florida 4155751 33024
    United States

    Site Not Available

  • Vantage Clinical Trials - Tampa - ClinEdge - PPDS

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • OrthoIllinois, LTD

    Rockford, Illinois 61114-4937
    United States

    Site Not Available

  • Arnold Arthritis and Rheumatology

    Skokie, Illinois 60076
    United States

    Site Not Available

  • OrthoIllinois, LTD

    Rockford 4907959, Illinois 4896861 61114-4937
    United States

    Site Not Available

  • Arnold Arthritis and Rheumatology

    Skokie 4911600, Illinois 4896861 60076
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana 70836
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    Baton Rouge 4315588, Louisiana 4331987 70836
    United States

    Site Not Available

  • Tufts University School of Dental Medicine

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Tufts University School of Dental Medicine

    Boston 4930956, Massachusetts 6254926 02111
    United States

    Site Not Available

  • Kirk Kerkorian School of Medicine UNLV

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Albuquerque Center for Rheumatology

    Albuquerque 5454711, New Mexico 5481136 87102
    United States

    Site Not Available

  • Bradenton Research Center Inc

    The Bronx, New York 34205-1704
    United States

    Site Not Available

  • Bradenton Research Center Inc

    The Bronx 5110266, New York 5128638 34205-1704
    United States

    Site Not Available

  • DJL Clinical Research PLLC

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • DJL Clinical Research PLLC

    Charlotte 4460243, North Carolina 4482348 28210
    United States

    Site Not Available

  • STAT Research

    Dayton, Ohio 45402
    United States

    Site Not Available

  • STAT Research

    Vandalia, Ohio 45377
    United States

    Site Not Available

  • Ruppert Health Center

    Toledo 5174035, Ohio 5165418 43614
    United States

    Site Not Available

  • STAT Research

    Vandalia 4527124, Ohio 5165418 45377
    United States

    Site Not Available

  • Toyos Clinic-Memphis

    Nashville 4644585, Tennessee 4662168 37215
    United States

    Site Not Available

  • Allen Arthritis

    Allen, Texas 75013
    United States

    Site Not Available

  • Tekton Research, LLC

    Austin, Texas 78745
    United States

    Site Not Available

  • Accurate Clinical Research - Houston

    Houston, Texas 77089
    United States

    Site Not Available

  • Advanced Rheumatology of Houston

    Houston, Texas 77058
    United States

    Site Not Available

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Site Not Available

  • Accurate Clinical Management, LLC

    Katy, Texas 77449
    United States

    Site Not Available

  • R & H Clinical Research

    Katy, Texas 77450
    United States

    Site Not Available

  • Accurate Clinical Management, LLC

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Advanced Rheumatology of Houston

    The Woodlands, Texas 77382
    United States

    Site Not Available

  • Allen Arthritis

    Allen 4670300, Texas 4736286 75013
    United States

    Site Not Available

  • Tekton Research, LLC

    Austin 4671654, Texas 4736286 78745
    United States

    Site Not Available

  • Accurate Clinical Research - Houston

    Houston 4699066, Texas 4736286 77089
    United States

    Site Not Available

  • Advanced Rheumatology of Houston

    Houston 4699066, Texas 4736286 77058
    United States

    Active - Recruiting

  • Accurate Clinical Management, LLC

    Katy 4702732, Texas 4736286 77449
    United States

    Active - Recruiting

  • R & H Clinical Research

    Katy 4702732, Texas 4736286 77450
    United States

    Site Not Available

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