A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
EnVISage
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
1 other identifier
interventional
83
8 countries
64
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2025
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 15, 2025
CompletedStudy Start
First participant enrolled
April 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 4, 2027
March 18, 2026
March 1, 2026
1.9 years
March 25, 2025
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) score
Higher scores on the ESSDAI indicate a worse outcome, as they reflect higher disease activity. Minimum value is 0 and the maximum value is 123.
28 weeks
Secondary Outcomes (29)
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) score
28 weeks
Incidence of treatment-emergent adverse events (TEAEs)
28 weeks
Incidence of treatment-emergent adverse events (TEAEs) by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade
28 weeks
Incidence of treatment-emergent adverse events (TEAEs) with an outcome of death
28 weeks
Incidence of serious treatment-emergent adverse events (TEAEs)
28 weeks
- +24 more secondary outcomes
Study Arms (2)
400 mg Sibeprenlimab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
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
Cooper City, Florida, 33024, United States
Vantage Clinical Trials - Tampa - ClinEdge - PPDS
Tampa, Florida, 33606, United States
OrthoIllinois, LTD
Rockford, Illinois, 61114-4937, United States
Arnold Arthritis and Rheumatology
Skokie, Illinois, 60076, 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
Bradenton Research Center Inc
The Bronx, New York, 34205-1704, United States
DJL Clinical Research PLLC
Charlotte, North Carolina, 28210, United States
STAT Research
Vandalia, Ohio, 45377, United States
Allen Arthritis
Allen, Texas, 75013, United States
Tekton Research, LLC
Austin, Texas, 78745, United States
Advanced Rheumatology of Houston
Houston, Texas, 77058, United States
Accurate Clinical Research - Houston
Houston, Texas, 77089, United States
Accurate Clinical Management, LLC
Katy, Texas, 77449, United States
R & H Clinical Research
Katy, Texas, 77450, United States
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
Instituto CER S.A.
Quilmes, Buenos Aires, B1878DVB, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, S2000DEJ, Argentina
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, T4000, Argentina
DOM Centro de Reumatología
Buenos Aires, C1111AAH, Argentina
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Maffei Centro Médico
Buenos Aires, C1180AAD, Argentina
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Buenos Aires, C1406AGA, Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, J5402, Argentina
Medical Center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-15 A Vassil Aprilov Boulevard
Plovdiv, 4002, Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, 1407, Bulgaria
Diagnostic- Consultative Center Convex EOOD
Sofia, 1680, Bulgaria
Medical Center- Nova Clinic
Varna, 9000, Bulgaria
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh
Hamburg, 22391, Germany
Medicover München Ost MVZ
München, 81667, Germany
Olympion General Clinic
Pátrai, Achaïa, 264 43, Greece
Laiko General Hospital of Athens (Site 1)
Athens, Attica, 115 27, Greece
Laiko General Hospital of Athens (Site 2)
Athens, Attica, 115 27, Greece
General Hospital ''Asklepieio Voulas''
Voula, Attica, 166 73, Greece
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, 60-324, Poland
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-693, Poland
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
Wroclaw, Lower Silesian Voivodeship, 50-570, Poland
ETG Siedlce - PPDS
Siedlce, Masovian Voivodeship, 08-110, Poland
Klinika Reuma Park sp . zoo Sp.k.
Warsaw, Masovian Voivodeship, 02-665, Poland
Centrum Medyczne K2J2 - Wołomin
Wołomin, Masovian Voivodeship, 05-200, Poland
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065, Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
NZOZ Holsamed - Oddzial Libero
Katowice, 40-600, Poland
Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
Lublin, 20-607, Poland
Pratia Poznan - PPDS
Poznan, 60-192, Poland
ETG Warszawa - PPDS
Warsaw, 02-677, Poland
Policlinica SelfMed Clinique
Timișoara, Timiș County, 300133, Romania
Sf.Maria Clinical Hospital
Bucharest, 11172, Romania
Colentina Clinical Hospital
Bucharest, 20125, Romania
Cluj-Napoca Emergency Clinical County Hospital
Cluj-Napoca, 400006, Romania
Medart Cliniq
Râmnicu Vâlcea, 240226, Romania
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital General Universitari de Castello
Castelló, 12004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital de Torrevieja
Torrevieja, 3186, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2025
First Posted
April 15, 2025
Study Start
April 23, 2025
Primary Completion (Estimated)
March 13, 2027
Study Completion (Estimated)
June 4, 2027
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.