Sjogren DiseasePhase 2EnVISageNCT06928142
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
A Phase 2 study testing Sibeprenlimab in people with Sjogren Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 64 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogren Disease
- What is being tested?
- Sibeprenlimab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 64 sitesin 8 countries
- Study dates
- 23 Apr 2025to 4 Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
64 sites in 8 countries.
64 sites in 8 countries
United States20 sites
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102
Allen Arthritis
Allen, Texas, 75013
Tekton Research, LLC
Austin, Texas, 78745
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70836
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
DJL Clinical Research PLLC
Charlotte, North Carolina, 28210
Clinical Research of West Florida Inc
Clearwater, Florida, 33765
GNP Research - Florida
Cooper City, Florida, 33024
Advanced Rheumatology of Houston
Houston, Texas, 77058
Accurate Clinical Research - Houston
Houston, Texas, 77089
Accurate Clinical Management, LLC
Katy, Texas, 77449
R & H Clinical Research
Katy, Texas, 77450
Medvin Clinical Research - Riverside
Riverside, California, 92508
OrthoIllinois, LTD
Rockford, Illinois, 61114-4937
Arnold Arthritis and Rheumatology
Skokie, Illinois, 60076
Vantage Clinical Trials - Tampa - ClinEdge - PPDS
Tampa, Florida, 33606
Bradenton Research Center Inc
The Bronx, New York, 34205-1704
Medvin Clinical Research - Tujunga
Tujunga, California, 91042
STAT Research
Vandalia, Ohio, 45377
Poland12 sites
MICS Centrum Medyczne Bydgoszcz
Bydgoszcz, 85-065
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
NZOZ Holsamed - Oddzial Libero
Katowice, 40-600
Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4
Lublin, 20-607
Twoja Przychodnia PCM
Poznan, Greater Poland Voivodeship, 60-324
Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-693
Pratia Poznan - PPDS
Poznan, 60-192
ETG Siedlce - PPDS
Siedlce, Masovian Voivodeship, 08-110
Klinika Reuma Park sp . zoo Sp.k.
Warsaw, Masovian Voivodeship, 02-665
ETG Warszawa - PPDS
Warsaw, 02-677
Centrum Medyczne K2J2 - Wołomin
Wołomin, Masovian Voivodeship, 05-200
Pracownia Badan Klinicznych Salus - ul. Ołtaszyńska 92c/3
Wroclaw, Lower Silesian Voivodeship, 50-570
Argentina10 sites
DOM Centro de Reumatología
Buenos Aires, C1111AAH
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires, C1128AAF
Maffei Centro Médico
Buenos Aires, C1180AAD
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Buenos Aires, C1406AGA
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP
Instituto CER S.A.
Quilmes, Buenos Aires, B1878DVB
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, S2000DEJ
Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan
San Juan, J5402
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, T4000
Bulgaria5 sites
Medical Center Medconsult Pleven OOD
Pleven, 5800
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-15 A Vassil Aprilov Boulevard
Plovdiv, 4002
Medical Center Excelsior OOD - PPDS
Sofia, 1407
Diagnostic- Consultative Center Convex EOOD
Sofia, 1680
Medical Center- Nova Clinic
Varna, 9000
Romania5 sites
Sf.Maria Clinical Hospital
Bucharest, 11172
Colentina Clinical Hospital
Bucharest, 20125
Cluj-Napoca Emergency Clinical County Hospital
Cluj-Napoca, 400006
Medart Cliniq
Râmnicu Vâlcea, 240226
Policlinica SelfMed Clinique
Timișoara, Timiș County, 300133
Germany4 sites
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh
Hamburg, 22391
Medicover München Ost MVZ
München, 81667
Greece4 sites
Laiko General Hospital of Athens (Site 1)
Athens, Attica, 115 27
Laiko General Hospital of Athens (Site 2)
Athens, Attica, 115 27
Olympion General Clinic
Pátrai, Achaïa, 264 43
General Hospital ''Asklepieio Voulas''
Voula, Attica, 166 73
Spain4 sites
Hospital General Universitari de Castello
Castelló, 12004
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital de Torrevieja
Torrevieja, 3186
About this study
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
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.
Read the detailed 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.
- Conditions
- Sjogren Disease
- Being tested
- Sibeprenlimab, Placebo
- Keywords
- Sibeprenlimab, Autoimmune Diseases, Immune System Diseases, Dry Mouth, Dry Eyes, Salivary Gland Disorders, Lacrimal Gland Disorders, Immunoglobulin G, EnVISage
- Medical subject headings
- Autoimmune Diseases, Immune System Diseases, Xerostomia, Dry Eye Syndromes, Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibeprenlimabBiological
400 mg administered SC Q4 weeks
PlaceboOther
Administered SC Q4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 400 mg Sibeprenlimab | Experimental | Not described Receives: Biological: Sibeprenlimab |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 weeks
Secondary outcomes (29)
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) score
Higher scores on the ESSPRI indicate a worse outcome, as they reflect higher levels of patient-reported symptoms. Minimum value is 0, maximum value is 10.
Measured: 28 weeks
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 28 weeks
Incidence of treatment-emergent adverse events (TEAEs) by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade
Measured: 28 weeks
Incidence of treatment-emergent adverse events (TEAEs) with an outcome of death
Measured: 28 weeks
Incidence of serious treatment-emergent adverse events (TEAEs)
Measured: 28 weeks
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of the investigational medicinal product (IMP)
Measured: 28 weeks
Proportion of participants with minimal clinical improvement defined as European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) reduction ≥ 3 points from baseline
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.
Measured: At 28 weeks
Proportion of participants with minimal clinical improvement defined as European League Against Rheumatism Sjögren's Syndrome Patient-Reported Index (ESSPRI) reduction ≥ 1 point from baseline
Higher scores on the ESSPRI indicate a worse outcome, as they reflect higher levels of patient-reported symptoms. Minimum value is 0, maximum value is 10.
Measured: At 28 weeks
Change from baseline in individual European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) domains
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.
Measured: At 28 weeks
Change from baseline in salivary flow rate
Measured: At 28 weeks
Change from baseline in tear flow rate
Measured: At 28 weeks
Change from baseline in Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ClinESSDAI) score
Higher scores on the ClinESSDAI indicate a worse outcome, as they reflect higher disease activity. Minimum value is 0 and the maximum value is 123.
Measured: At 28 weeks
Change from baseline in Physician Global Assessment (PhGA) score
Higher scores on the PhGA indicate a worse outcome, as they reflect a higher assessment of disease activity or severity by the physician. Minimum value is 0 and the maximum value is 10.
Measured: At 28 weeks
Change from baseline in Patient Global Assessment (PaGA) score of participant outcomes
Higher scores on the PaGA indicate a worse outcome, as they reflect a higher assessment of disease severity or impact by the patient. Minimum value is 0 and the maximum value is 10.
Measured: At 28 weeks
Change from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) score
Higher FACIT-Fatigue scores indicate a better outcome, as they reflect less fatigue. Minimum value is 0 and the maximum value is 52.
Measured: At 28 weeks
Change from baseline in 36 Item Short-Form Survey Version 2 (SF-36v2) Physical Component Summary Scale score and Mental Component Summary Scale score
Higher scores on the SF-36v2 indicate a better outcome, as they reflect better health status and quality of life. Minimum value is 0 and the maximum value is 100.
Measured: At 28 weeks
Change from baseline in patient-reported Sjögren's disease diary score
Higher diary score indicates more severe symptoms and greater impact on the patient's daily life. Minimum value is 0 and the maximum value is 10.
Measured: At 28 weeks
Proportion of participants with minimal clinical improvement, defined as Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) score increase of ≥ 4 from baseline
Higher FACIT-Fatigue scores indicate a better outcome, as they reflect less fatigue. Minimum value is 0 and the maximum value is 52.
Measured: At 28 weeks
Time to the first occurrence of minimal clinical improvement in ESSDAI
Measured: Week 28
Time to the first occurrence of minimal clinical improvement in ESSPRI
Measured: Week 28
Percent change from baseline in total serum IgA
Measured: Week 28
Percent change from baseline in total serum IgG
Measured: Week 28
Percent change from baseline in total serum IgM
Measured: Week 28
Percent change from baseline in total serum free APRIL (a proliferation-inducing ligand) concentrations
Measured: Week 28
Cmax of sibeprenlimab
Measured: 28 weeks
Tmax of sibeprenlimab
Measured: 28 weeks
Area Under the Curve (AUC) of sibeprenlimab
Measured: 28 weeks
Serum concentration of sibeprenlimab
Measured: 28 weeks
Presence or absence of serum antidrug antibody (ADA) to sibeprenlimiab
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start23 Apr 2025
- Primary completion13 Mar 2027 (estimated)
- Study completion4 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren DiseaseStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928142
- Sponsor's protocol ID
- 417-201-00042
- Acronym
- EnVISage
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.