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Sjögren's drug trial halted: what happened?

NCT ID NCT06312020

Disease control Sponsor: Amgen 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 HZN-1116 in 209 people with Sjögren's syndrome, an autoimmune disease causing dry eyes and mouth. The goal was to see if the drug could reduce disease activity and symptoms. The trial was terminated early, so results may not be available.

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

209 people

The number who actually took part.

Started

May 2024

Finished

Apr 2026

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 SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria. * Have an ESSDAI score of \>= 5 at screening (only for Population 1). * Have an ESSPRI score of \>= 5 at screening (only for Population 2). * Have an ESSDAI score of \< 5 at screening (only for Population 2). * Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both at screening. Key Exclusion Criteria: * Concomitant system sclerosis. * Active malignancy or history of malignancy within the last 5 years with exception of in situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR cutaneous basal cell carcinoma following presumed curative therapy. * Individuals who are pregnant or lactating or planning to become pregnant during the study. * Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or HIV infection. * Individuals with history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. Individuals with a prior history of ophthalmic herpes zoster will be excluded. * Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening. * Last administration of experimental biologic or oral agents \< 6 months or 5 half-lives, whichever is longer, before screening. * Individuals who have had previous treatment with any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, or ofatumumab) within 12 months or other B cell targeting therapy (eg, belimumab) or anti-type I IFN pathway therapy (eg, anifrolumab) \< 6 months before randomization.

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Conditions

The condition(s) this trial relates to.

autoimmune disease dry eye syndrome 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

  • AES - AS - Fundacion Centro de Investigacion Clinica - CIC

    Medellín, 050021, Colombia

  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

    Warsaw, Masovian Voivodeship, 02-672, Poland

  • Altoona Center for Clinical Research - 175 Meadowbrook Ln

    Duncansville, Pennsylvania, 16635-8445, United States

  • Arizona Arthritis & Rheumatology Research-S Vineyard Ave

    Mesa, Arizona, 85210-6871, United States

  • Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

    Phoenix, Arizona, 85032-9306, United States

  • Augusta University Medical Center-Augusta-1120 15th St

    Augusta, Georgia, 30912-0004, United States

  • Basingstoke and North Hampshire Hospital

    Basingstoke, Hampshire, RG24 9NA, United Kingdom

  • Biomedica Research Group

    Providencia, Región-MetropolitanadeSantiago, 7500000, Chile

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, Hérault, 34295, France

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200, France

  • Centro Integral de Reumatologia del Caribe S.A.S - CIRCARIBE S.A.S.

    Barranquilla, Atlántico, 080001, Colombia

  • Centro Privado de Medicina Familiar

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1417, Argentina

  • Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

    Viña del Mar, Valparaiso, 2531172, Chile

  • Centro de especialidades médicas Vanguardia

    Temuco, Araucania, 4780000, Chile

  • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.

    Malbork, Pomeranian Voivodeship, 82-200, Poland

  • Centrum Medyczne PROMED

    Krakow, Lesser Poland Voivodeship, 31-513, Poland

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305, Taiwan

  • Clinical Research of West Florida Inc - Tampa

    Tampa, Florida, 33606-1246, United States

  • Clinicas Gaias-Santiago

    Santiago de Compostela, 15702, Spain

  • Clinstile, S.A. de C.V.

    Mexico City, C.P. 06700, Mexico

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina

  • DJL Clinical Research PLLC-431 N Wendover Rd

    Charlotte, North Carolina, 28211-1064, United States

  • DOM Centro de Reumatología

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1107, Argentina

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7

    Budapest, 1097, Hungary

  • Expertia S.A- Mautalén Salud e Investigación

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1128AAF, Argentina

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Rome, Lazio, 00168, Italy

  • FutureMeds - Krakow - PPDS

    Krakow, 31-501, Poland

  • FutureMeds - Targowek - PPDS

    Warsaw, Masovian Voivodeship, 03-291, Poland

  • Healthy Medical Center S.A.S.

    Zipaquirá, Cundinamarca, 250252, Colombia

  • Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima

    Ponte de Lima, 4990-041, Portugal

  • Hospital General Universitario de Castellon

    Castellon, 12004, Spain

  • Hospital Quironsalud Sagrado Corazon

    Seville, 41013, Spain

  • Hospital Sanitas CIMA

    Barcelona, 08034, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • IRCCS Ospedale Galeazzi - Sant'Ambrogio

    Milan, Lombardy, 20157, Italy

  • IRIS Research and Development LLC

    Plantation, Florida, 33324-2736, United States

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362, Taiwan

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, Masovian Voivodeship, 02-665, Poland

  • LKH-Universitätsklinikum Graz - Auenbruggerplatz 15

    Graz, Styria, 8036, Austria

  • Life Arc Research Centers Corp

    Miami, Florida, 33126, United States

  • MICS Centrum Medyczne Warszawa, Wronia - MICS

    Warsaw, Masovian Voivodeship, 00-874, Poland

  • MR Medicina Reumatologica

    San Fernando, Buenos Aires, B1646GHP, Argentina

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

    Hamburg, 20095, Germany

  • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. El. Reicher- Spartanska 1

    Warsaw, Masovian Voivodeship, 02-637, Poland

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Neurovations Research

    Napa, California, 94558-2415, United States

  • PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS

    Guadalajara, Jalisco, 44670, Mexico

  • Pioneer Clinical Research NY

    New York, New York, 10016-7313, United States

  • Pratia Poznan - PPDS

    Poznan, Greater Poland Voivodeship, 60-192, Poland

  • Prolato Clinical Research Center

    Houston, Texas, 77054-2853, United States

  • Prosalud y Cia Ltda.

    Santiago, Región-MetropolitanadeSantiago, 7510047, Chile

  • Prywatna Praktyka Lekarska Pawel Hrycaj

    Poznan, Greater Poland Voivodeship, 61-397, Poland

  • R & H Clinical Research - Katy - 1531 Westborough Dr

    Katy, Texas, 77449, United States

  • Servimed S.A.S

    Bucaramanga, 680003, Colombia

  • Taipei Medical University Hospital - PPDS

    Taipei, 11031, Taiwan

  • Tekton Research, LLC - W Gate Blvd - Austin - PPDS

    Austin, Texas, 78745, United States

  • Tufts Medical Center - 800 Washington St - PPDS

    Boston, Massachusetts, 02111-1552, United States

  • ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS

    Lisbon, 1649-035, Portugal

  • ULS de Santo António, EPE - Hospital de Santo António

    Porto, 4099-001, Portugal

  • University Of Wisconsin - Madison

    Madison, Wisconsin, 53792-0001, United States

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305-2883, United States

More trials for these conditions

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