Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug shows promise for Sjogren's sufferers

NCT ID NCT04968912

Disease control Sponsor: Janssen Research & Development, LLC 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental drug called nipocalimab in 163 adults with primary Sjogren's syndrome, an autoimmune disease causing dryness and fatigue. Participants received either the drug or a placebo for 24 weeks. The goal was to see if nipocalimab could reduce overall disease activity better than a placebo.

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

163 people

The number who actually took part.

Started

Sep 2021

Finished

Nov 2023

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.

Inclusion Criteria: * Meets classification criteria for primary Sjogren's syndrome (pSS) by the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) at the time of screening (results either obtained during screening or documented in the participant's medical history are acceptable to fulfill these criteria for Schirmer's test, unstimulated salivary flow test, ocular staining score, or labial salivary gland biopsy), and was diagnosed with pSS no less than 26 weeks prior to screening * At screening is seropositive for antibodies to pSS-associated antigen A (Ro/Sjogren's syndrome-related antigen A \[SSA\]) * Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (clinESSDAI) score greater than or equal to (\>=) 6 * At least one abnormal laboratory marker of pSS-related inflammatory disease activity, and at least low activity in one or more specified European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) domains * It is recommended to be up to date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. It is strongly recommended that participants will have completed a locally-approved (or emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccination regimen at least 2 weeks prior to study related visits or procedures. Study participants should, follow applicable local vaccine labelling, guidelines, and standards-of-care for participants receiving immune-targeted therapy will be followed when determining an appropriate interval between vaccination and study enrollment Exclusion Criteria: * Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her pSS or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant * Comorbidities (for example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months * Has any unstable or progressive manifestation of pSS that is likely to warrant escalation in therapy beyond permitted background medications and/or has severely active pSS * Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention * Has Sjogren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition (for example, rheumatoid arthritis \[RA\], systemic lupus erythematosus \[SLE\], scleroderma, inflammatory bowel disease \[IBD\]) is the primary diagnosis or has clinical manifestations that, in the opinion of the investigator, or the sponsor or sponsor's representative, are likely to interfere with the investigator's ability to assess pSS manifestations

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sjogren's syndrome are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Sjogren syndrome

As listed by the trial registrant

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

Sjogren's syndrome

Contacts and locations

Locations

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Anniston Medical Clinic

    Anniston, Alabama, 36207, United States

  • Arizona Arthritis & Rheumatology Research, PLLC

    Mesa, Arizona, 85210, United States

  • Arizona Arthritis and Rheumatology Research PLLC

    Glendale, Arizona, 85306, United States

  • Austin Regional Clinic

    Austin, Texas, 78731-3146, United States

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126, Italy

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90129, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

    Brescia, 25123, Italy

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511, United States

  • CHRU Hôpital de Hautepierre

    Strasbourg, 67098, France

  • CHU de Grenoble Hopital Albert Michallon

    La Tronche, 38700, France

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

  • Centre for Rheumatology, Immunology and Arthritis

    Fort Lauderdale, Florida, 33309, United States

  • Centrum Medyczne

    Poznan, 61 113, Poland

  • Centrum Medyczne AMED Targowek

    Warsaw, 03 291, Poland

  • Centrum Medyczne Oporow

    Wroclaw, 52 415, Poland

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan, 333, Taiwan

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Clinical Investigation Specialists

    Gurnee, Illinois, 60031, United States

  • Colorado Arthritis Associates

    Denver, Colorado, 80228, United States

  • Columbia Arthritis Center

    Columbia, South Carolina, 29204, United States

  • Corporacio Sanitari Parc Tauli

    Sabadell, 08208, Spain

  • Denver Arthritis Clinic

    Denver, Colorado, 80230, United States

  • Dr. Ramesh Gupta

    Memphis, Tennessee, 38119, United States

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD, Netherlands

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095, Germany

  • Hokkaido University Hospital

    Sapporo, 060-8648, Japan

  • Hopital Pitie Salpetriere

    Paris, 75013, France

  • Hopital Saint Joseph

    Marseille, 13285, France

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp Univ A Coruna

    A Coruña, 15006, Spain

  • Hosp. Infanta Luisa

    Seville, 41010, Spain

  • Hosp. de Merida

    Mérida, 6800, Spain

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Inland Rheumatology Clinical Trials, Inc.

    Upland, California, 91786, United States

  • Instituto Portugues de Reumatologia

    Lisbon, 1050-034, Portugal

  • Malopolskie Badania Kliniczne Sp z o o

    Krakow, 30-002, Poland

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD, Netherlands

  • Medycyna Kliniczna

    Warsaw, 00-874, Poland

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher

    Warsaw, 02 637, Poland

  • Nasz Lekarz Przychodnie Medyczne

    Bydgoszcz, 85-065, Poland

  • Nihon University Itabashi Hospital

    Tokyo, 173 8610, Japan

  • North Mississippi Medical Clinics

    Tupelo, Mississippi, 38801, United States

  • Omega Research Consultants

    Orlando, Florida, 32835, United States

  • P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

    Catania, 95100, Italy

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144, United States

  • REUMED Zespol Poradni Specjalistycznych Filia nr 2

    Lublin, 20-607, Poland

  • Rheumatology Associates Of South Florida

    Boca Raton, Florida, 33486, United States

  • St. Jude Heritage Medical Group

    Fullerton, California, 92835, United States

  • St. Luke's International Hospital

    Tokyo, 104 8560, Japan

  • St. Paul Rheumatology P A

    Eagan, Minnesota, 55121, United States

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Tokyo Metropolitan Tama Medical Center

    Fuchū, 183 8524, Japan

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • Trinity Clinical Research, LLC

    Carrollton, Texas, 75007, United States

  • ULSAM, EPE - Hospital Conde de Bertiandos

    Ponte de Lima, 4990-078, Portugal

  • Uniklinik Köln

    Cologne, 50923, Germany

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, 01307, Germany

  • Universitatsklinikum Tubingen

    Tübingen, 72076, Germany

  • University of Florida Health Jacksonville

    Jacksonville, Florida, 32209, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Tsukuba Hospital

    Tsukuba, 305-8520, Japan

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305, United States

  • Zespolu Opieki Zdrowotnej w Konskich

    Gmina Końskie, 26 200, Poland

  • medius KLINIK KIRCHHEIM

    Kirchheim unter Teck, 73230, Germany

More trials for these conditions

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