A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

May 6, 2026 updated by: Amgen

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren's Syndrome

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study will enroll 2 SS populations: Population 1 will include participants with moderate to high systemic disease activity; Population 2 will include participants with moderate to severe subjective symptoms. This study will include 3 periods: screening (5 weeks), treatment period (48 Weeks) and follow-up period (12 weeks). In the treatment period, participants from each of the populations will be randomized to receive subcutaneous (SC) dose of HZN-1116 or placebo.

Acquired from Horizon in 2024.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • San Fernando, Buenos Aires, Argentina, B1646GHP
        • MR Medicina Reumatologica
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1107
        • DOM Centro de Reumatología
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1128AAF
        • Expertia S.A- Mautalén Salud e Investigación
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1417
        • Centro Privado de Medicina Familiar
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1426ABP
        • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • LKH-Universitätsklinikum Graz - Auenbruggerplatz 15
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Centro de especialidades médicas Vanguardia
    • Región-MetropolitanadeSantiago
      • Providencia, Región-MetropolitanadeSantiago, Chile, 7500000
        • BioMedica Research Group
      • Santiago, Región-MetropolitanadeSantiago, Chile, 7510047
        • Prosalud y Cia Ltda.
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2531172
        • Centro de Investigacion de Enfermedades Respiratorias e Inmunologicas
  • Colombia
      • Bucaramanga, Colombia, 680003
        • Servimed S.A.S
      • Medellín, Colombia, 050021
        • AES - AS - Fundacion Centro de Investigacion Clinica - CIC
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080001
        • Centro Integral de Reumatologia del Caribe S.A.S - CIRCARIBE S.A.S.
    • Cundinamarca
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • Healthy Medical Center S.A.S.
  • France
      • Strasbourg, France, 67200
        • CHU de Strasbourg - Hôpital de Hautepierre
    • Hérault
      • Montpellier, Hérault, France, 34295
        • CHU de Montpellier - Hôpital Lapeyronie
  • Germany
      • Hamburg, Germany, 20095
        • Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Medizinische Hochschule Hannover
  • Hungary
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
    • Lombardy
      • Milan, Lombardy, Italy, 20157
        • IRCCS Ospedale Galeazzi - Sant'Ambrogio
  • Mexico
      • Mexico City, Mexico, C.P. 06700
        • Clinstile, S.A. de C.V.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS
  • Poland
      • Krakow, Poland, 31-501
        • FutureMeds - Krakow - PPDS
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-192
        • Pratia Poznan - PPDS
      • Poznan, Greater Poland Voivodeship, Poland, 61-397
        • Prywatna Praktyka Lekarska Pawel Hrycaj
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-513
        • Centrum Medyczne Promed
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-665
        • Klinika Reuma Park sp . zoo Sp.k.
      • Warsaw, Masovian Voivodeship, Poland, 02-672
        • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
      • Warsaw, Masovian Voivodeship, Poland, 03-291
        • FutureMeds - Targowek - PPDS
      • Warsaw, Masovian Voivodeship, Poland, 02-637
        • Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. El. Reicher- Spartanska 1
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • MICS Centrum Medyczne Warszawa, Wronia - MICS
    • Pomeranian Voivodeship
      • Malbork, Pomeranian Voivodeship, Poland, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. z o.o.
  • Portugal
      • Lisbon, Portugal, 1649-035
        • ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
      • Ponte de Lima, Portugal, 4990-041
        • Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
      • Porto, Portugal, 4099-001
        • ULS de Santo António, EPE - Hospital de Santo António
  • Spain
      • Barcelona, Spain, 08034
        • Hospital Sanitas CIMA
      • Castellon, Spain, 12004
        • Hospital General Universitario de Castellon
      • Granada, Spain, 18014
        • Hospital Universitario Virgen De Las Nieves
      • Santiago de Compostela, Spain, 15702
        • Clinicas Gaias-Santiago
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41013
        • Hospital Quirónsalud Sagrado Corazón
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung City, Taiwan, 83301
        • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11031
        • Taipei Medical University Hospital - PPDS
      • Taoyuan City, Taiwan, 33305
        • Chang Gung Memorial Hospital, Linkou
  • United Kingdom
    • Hampshire
      • Basingstoke, Hampshire, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210-6871
        • Arizona Arthritis & Rheumatology Research-S Vineyard Ave
      • Phoenix, Arizona, United States, 85032-9306
        • Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd
    • California
      • Napa, California, United States, 94558-2415
        • Neurovations Research
    • Florida
      • Miami, Florida, United States, 33126
        • Life Arc Research Centers Corp
      • Plantation, Florida, United States, 33324-2736
        • IRIS Research and Development LLC
      • Tampa, Florida, United States, 33606-1246
        • Clinical Research of West Florida Inc - Tampa
    • Georgia
      • Augusta, Georgia, United States, 30912-0004
        • Augusta University Medical Center-Augusta-1120 15th St
    • Massachusetts
      • Boston, Massachusetts, United States, 02111-1552
        • Tufts Medical Center - 800 Washington St - PPDS
    • New York
      • New York, New York, United States, 10016-7313
        • Pioneer Clinical Research NY
    • North Carolina
      • Charlotte, North Carolina, United States, 28211-1064
        • DJL Clinical Research PLLC-431 N Wendover Rd
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635-8445
        • Altoona Center for Clinical Research - 175 Meadowbrook Ln
    • Tennessee
      • Jackson, Tennessee, United States, 38305-2883
        • West Tennessee Research Institute
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research, LLC - W Gate Blvd - Austin - PPDS
      • Houston, Texas, United States, 77054-2853
        • Prolato Clinical Research Center
      • Katy, Texas, United States, 77449
        • R & H Clinical Research - Katy - 1531 Westborough Dr
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-0001
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HZN-1116 Dose 1 in Population 1
Participants will receive Dose 1 of HZN-1116
Drug: HZN-1116
Subcutaneous Administration
Other Names:
  • VIB1116
  • AMG 329
Experimental: HZN-1116 Dose 2 in Population 1
Participants will receive Dose 2 of HZN-1116
Drug: HZN-1116
Subcutaneous Administration
Other Names:
  • VIB1116
  • AMG 329
Placebo Comparator: Placebo in Population 1
Participants will receive Placebo matched to HZN-1116
Drug: Placebo
Subcutaneous Administration
Experimental: HZN-1116 Dose 1 in Population 2
Participants will receive Dose 1 of HZN-1116
Drug: HZN-1116
Subcutaneous Administration
Other Names:
  • VIB1116
  • AMG 329
Experimental: HZN-1116 Dose 2 in Population 2
Participants will receive Dose 2 of HZN-1116
Drug: HZN-1116
Subcutaneous Administration
Other Names:
  • VIB1116
  • AMG 329
Experimental: HZN-1116 Dose 3 in Population 2
Participants will receive Dose 3 of HZN-1116
Drug: HZN-1116
Subcutaneous Administration
Other Names:
  • VIB1116
  • AMG 329
Experimental: HZN-1116 Dose 4 in Population 2
Participants will receive Dose 4 of HZN-1116
Drug: HZN-1116
Subcutaneous Administration
Other Names:
  • VIB1116
  • AMG 329
Placebo Comparator: Placebo in Population 2
Participants will receive Placebo matched to HZN-1116
Drug: Placebo
Subcutaneous Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)
Time Frame: At Week 48
At Week 48
Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)
Time Frame: At Week 24
At Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in ESSDAI (Population #1)
Time Frame: At Week 24
At Week 24
Proportion of Participants achieving ESSDAI [5] response (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in ESSPRI pain domain score (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in ESSPRI fatigue domain score (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in DASPRI fatigue domain score (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in ESSPRI dryness domain score (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in DASSPRI dryness domain score (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in tender joint count (TJC) (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in swollen joint count (SJC) (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1)
Time Frame: At Week 24 and Week 48
At Week 24 and Week 48
Change from baseline in DASPRI (Population #2)
Time Frame: At Week 24
At Week 24
Proportion of Participants achieving ESSPRI [1.5] response (Population #2)
Time Frame: At Week 24
At Week 24
Change from baseline in ESSPRI pain domain (Population #2)
Time Frame: At Week 24
At Week 24
Change from baseline in ESSPRI fatigue domain (Population #2)
Time Frame: At Week 24
At Week 24
Change from baseline in ESSPRI dryness domain (Population #2)
Time Frame: At Week 24
At Week 24
Change from baseline in SF-36 PCS Score (Population #2)
Time Frame: At Week 24
At Week 24
Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2)
Time Frame: At Week 24
At Week 24
Change from baseline in PROMIS-Fatigue SF-10a (Population #2)
Time Frame: At Week 24
At Week 24
Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2)
Time Frame: Up to Week 60
Up to Week 60
Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2)
Time Frame: Up to Week 60
Up to Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Actual)

April 28, 2026

Study Completion (Actual)

April 28, 2026

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZNP-HZN-1116-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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