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New shot could tame Sjögren's Flare-Ups

NCT ID NCT06928142

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests whether sibeprenlimab, a biologic drug given as a shot every 4 weeks, can reduce disease activity and symptoms in people with Sjögren's disease. About 83 adults with moderate-to-active disease will receive either the drug or a placebo, added to their usual treatments. The study measures changes in disease activity scores and patient-reported symptoms over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sibeprenlimab (a biologic drug given as a shot under the skin every 4 weeks)
What this could lead to
If it works, this could point toward a new treatment option to better control Sjögren's disease activity and symptoms.
What could go wrong
This is an early Phase 2 trial with only 83 people, so results may not apply to everyone. The drug may not show clear benefit over placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

83 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. 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, and chronic and/or acute infections. * Suicidal ideation or behavior based on the Patient Health Questionnaire-9 (PHQ-9).

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Conditions

The condition(s) this trial relates to.

autoimmune disease dry eye syndrome immune system disorder salivary gland disorder Sjogren syndrome Xerostomia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sjogren disease

Contacts and locations

Locations

  • Accurate Clinical Management, LLC

    Katy, Texas, 77449, United States

  • Accurate Clinical Research - Houston

    Houston, Texas, 77089, United States

  • Advanced Rheumatology of Houston

    Houston, Texas, 77058, United States

  • Albuquerque Center for Rheumatology

    Albuquerque, New Mexico, 87102, United States

  • Allen Arthritis

    Allen, Texas, 75013, United States

  • Aprillus Asistencia e Investigacion de Arcis Salud SRL

    Buenos Aires, C1406AGA, Argentina

  • Arnold Arthritis and Rheumatology

    Skokie, Illinois, 60076, United States

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511, United States

  • Bradenton Research Center Inc

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

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

    San Juan, J5402, Argentina

  • Centro de Investigaciones Médicas Tucumán - PPDS

    San Miguel de Tucumán, Tucumán Province, T4000, Argentina

  • Centrum Medyczne K2J2 - Wołomin

    Wołomin, Masovian Voivodeship, 05-200, Poland

  • Clinical Research of West Florida Inc

    Clearwater, Florida, 33765, United States

  • Cluj-Napoca Emergency Clinical County Hospital

    Cluj-Napoca, 400006, Romania

  • Clínica Mayo de U.M.C.B. S.R.L

    San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

  • Colentina Clinical Hospital

    Bucharest, 20125, Romania

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

  • DJL Clinical Research PLLC

    Charlotte, North Carolina, 28210, United States

  • DOM Centro de Reumatología

    Buenos Aires, C1111AAH, Argentina

  • Diagnostic- Consultative Center Convex EOOD

    Sofia, 1680, Bulgaria

  • ETG Siedlce - PPDS

    Siedlce, Masovian Voivodeship, 08-110, Poland

  • ETG Warszawa - PPDS

    Warsaw, 02-677, Poland

  • Expertia S.A- Mautalén Salud e Investigación

    Buenos Aires, C1128AAF, Argentina

  • GNP Research - Florida

    Cooper City, Florida, 33024, United States

  • General Hospital ''Asklepieio Voulas''

    Voula, Attica, 166 73, Greece

  • Hospital General Universitari de Castello

    Castelló, 12004, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital de Torrevieja

    Torrevieja, 3186, Spain

  • Instituto CER S.A.

    Quilmes, Buenos Aires, B1878DVB, Argentina

  • Instituto Médico de la Fundación Estudios Clínicos

    Rosario, Santa Fe Province, S2000DEJ, Argentina

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, Masovian Voivodeship, 02-665, Poland

  • Laiko General Hospital of Athens (Site 1)

    Athens, Attica, 115 27, Greece

  • Laiko General Hospital of Athens (Site 2)

    Athens, Attica, 115 27, Greece

  • MICS Centrum Medyczne Bydgoszcz

    Bydgoszcz, 85-065, Poland

  • Maffei Centro Médico

    Buenos Aires, C1180AAD, Argentina

  • Med-Polonia Sp. z o.o.

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Medart Cliniq

    Râmnicu Vâlcea, 240226, Romania

  • Medical Center Excelsior OOD - PPDS

    Sofia, 1407, Bulgaria

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800, Bulgaria

  • Medical Center- Nova Clinic

    Varna, 9000, Bulgaria

  • Medicover München Ost MVZ

    München, 81667, Germany

  • Medvin Clinical Research - Riverside

    Riverside, California, 92508, United States

  • Medvin Clinical Research - Tujunga

    Tujunga, California, 91042, United States

  • Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

    Hamburg, 22391, Germany

  • NZOZ Holsamed - Oddzial Libero

    Katowice, 40-600, Poland

  • Ochsner Clinic Foundation

    Baton Rouge, Louisiana, 70836, United States

  • Olympion General Clinic

    Pátrai, Achaïa, 264 43, Greece

  • OrthoIllinois, LTD

    Rockford, Illinois, 61114-4937, United States

  • Policlinica SelfMed Clinique

    Timișoara, Timiș County, 300133, Romania

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

    Wroclaw, Lower Silesian Voivodeship, 50-570, Poland

  • Pratia Poznan - PPDS

    Poznan, 60-192, Poland

  • R & H Clinical Research

    Katy, Texas, 77450, United States

  • STAT Research

    Vandalia, Ohio, 45377, United States

  • Sf.Maria Clinical Hospital

    Bucharest, 11172, Romania

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

    Bydgoszcz, 85-168, Poland

  • Tekton Research, LLC

    Austin, Texas, 78745, United States

  • Tufts University School of Dental Medicine

    Boston, Massachusetts, 02111, United States

  • Twoja Przychodnia PCM

    Poznan, Greater Poland Voivodeship, 60-324, Poland

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

    Plovdiv, 4002, Bulgaria

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitätsklinikum Köln

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Vantage Clinical Trials - Tampa - ClinEdge - PPDS

    Tampa, Florida, 33606, United States

  • Zespol Poradni Specjalistycznych REUMED- Wallenroda 2F/4

    Lublin, 20-607, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.