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Sjogren's SyndromePhase 2NCT06312020

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

A Phase 2 study testing HZN-1116 in people with Sjogren's Syndrome, run by Amgen at 66 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Sjogren's Syndrome
What is being tested?
HZN-1116
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
209 participants
Where
66 sitesin 16 countries
Study dates
9 May 2024to 28 Apr 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 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.

Who cannot join

  • 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.

Trial locations and contacts

66 sites in 16 countries.

66 sites in 16 countries

United States16 sites

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

    Augusta, Georgia, 30912-0004

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

    Austin, Texas, 78745

  • Tufts Medical Center - 800 Washington St - PPDS

    Boston, Massachusetts, 02111-1552

  • DJL Clinical Research PLLC-431 N Wendover Rd

    Charlotte, North Carolina, 28211-1064

  • Altoona Center for Clinical Research - 175 Meadowbrook Ln

    Duncansville, Pennsylvania, 16635-8445

  • Prolato Clinical Research Center

    Houston, Texas, 77054-2853

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305-2883

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

    Katy, Texas, 77449

  • University Of Wisconsin - Madison

    Madison, Wisconsin, 53792-0001

  • Arizona Arthritis & Rheumatology Research-S Vineyard Ave

    Mesa, Arizona, 85210-6871

  • Life Arc Research Centers Corp

    Miami, Florida, 33126

  • Neurovations Research

    Napa, California, 94558-2415

  • Pioneer Clinical Research NY

    New York, New York, 10016-7313

  • Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

    Phoenix, Arizona, 85032-9306

  • IRIS Research and Development LLC

    Plantation, Florida, 33324-2736

  • Clinical Research of West Florida Inc - Tampa

    Tampa, Florida, 33606-1246

Other trials in United States

Poland10 sites

  • Centrum Medyczne PROMED

    Krakow, Lesser Poland Voivodeship, 31-513

  • FutureMeds - Krakow - PPDS

    Krakow, 31-501

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

    Malbork, Pomeranian Voivodeship, 82-200

  • Pratia Poznan - PPDS

    Poznan, Greater Poland Voivodeship, 60-192

  • Prywatna Praktyka Lekarska Pawel Hrycaj

    Poznan, Greater Poland Voivodeship, 61-397

  • MICS Centrum Medyczne Warszawa, Wronia - MICS

    Warsaw, Masovian Voivodeship, 00-874

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

    Warsaw, Masovian Voivodeship, 02-637

  • Klinika Reuma Park sp . zoo Sp.k.

    Warsaw, Masovian Voivodeship, 02-665

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

    Warsaw, Masovian Voivodeship, 02-672

  • FutureMeds - Targowek - PPDS

    Warsaw, Masovian Voivodeship, 03-291

Other trials in Poland

Spain6 sites

  • Hospital Sanitas CIMA

    Barcelona, 08034

  • Hospital General Universitario de Castellon

    Castellon, 12004

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Clinicas Gaias-Santiago

    Santiago de Compostela, 15702

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Quironsalud Sagrado Corazon

    Seville, 41013

Other trials in Spain

Argentina5 sites

  • DOM Centro de Reumatología

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1107

  • Expertia S.A- Mautalén Salud e Investigación

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1128AAF

  • Centro Privado de Medicina Familiar

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1417

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP

  • MR Medicina Reumatologica

    San Fernando, Buenos Aires, B1646GHP

Other trials in Argentina

Taiwan5 sites

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Medical University Hospital - PPDS

    Taipei, 11031

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305

Other trials in Taiwan

Chile4 sites

  • Biomedica Research Group

    Providencia, Región-MetropolitanadeSantiago, 7500000

  • Prosalud y Cia Ltda.

    Santiago, Región-MetropolitanadeSantiago, 7510047

  • Centro de especialidades médicas Vanguardia

    Temuco, Araucania, 4780000

  • Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

    Viña del Mar, Valparaiso, 2531172

Other trials in Chile

Colombia4 sites

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

    Barranquilla, Atlántico, 080001

  • Servimed S.A.S

    Bucaramanga, 680003

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

    Medellín, 050021

  • Healthy Medical Center S.A.S.

    Zipaquirá, Cundinamarca, 250252

Other trials in Colombia

Portugal3 sites

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

    Lisbon, 1649-035

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

    Ponte de Lima, 4990-041

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

    Porto, 4099-001

Other trials in Portugal

France2 sites

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, Hérault, 34295

  • CHU de Strasbourg - Hôpital de Hautepierre

    Strasbourg, 67200

Other trials in France

Germany2 sites

  • Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

    Hamburg, 20095

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

Other trials in Germany

Hungary2 sites

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

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, Hajdú-Bihar, 4032

Other trials in Hungary

Italy2 sites

  • IRCCS Ospedale Galeazzi - Sant'Ambrogio

    Milan, Lombardy, 20157

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Rome, Lazio, 00168

Other trials in Italy

Mexico2 sites

  • PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS

    Guadalajara, Jalisco, 44670

  • Clinstile, S.A. de C.V.

    Mexico City, C.P. 06700

Other trials in Mexico

Austria1 site

  • LKH-Universitätsklinikum Graz - Auenbruggerplatz 15

    Graz, Styria, 8036

Other trials in Austria

Switzerland1 site

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

Other trials in Switzerland

United Kingdom1 site

  • Basingstoke and North Hampshire Hospital

    Basingstoke, Hampshire, RG24 9NA

Other trials in United Kingdom

About this study

Official title: 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).

Read the 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.

Being tested
HZN-1116, Placebo
Keywords
SS, Sjogren's, HZN-1116, Autoimmune disease, Dry Eye syndrome, VIB1116
Medical subject headings
Sjogren's Syndrome, Autoimmune Diseases, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HZN-1116Drug

    Also called VIB1116, AMG 329

    Subcutaneous Administration

  • PlaceboDrug

    Subcutaneous Administration

Study groups in NCT06312020
Study groupRoleWhat they receive
HZN-1116 Dose 1 in Population 1ExperimentalParticipants will receive Dose 1 of HZN-1116
Receives: Drug: HZN-1116
HZN-1116 Dose 2 in Population 1ExperimentalParticipants will receive Dose 2 of HZN-1116
Receives: Drug: HZN-1116
Placebo in Population 1Placebo comparatorParticipants will receive Placebo matched to HZN-1116
Receives: Drug: Placebo
HZN-1116 Dose 1 in Population 2ExperimentalParticipants will receive Dose 1 of HZN-1116
Receives: Drug: HZN-1116
HZN-1116 Dose 2 in Population 2ExperimentalParticipants will receive Dose 2 of HZN-1116
Receives: Drug: HZN-1116
HZN-1116 Dose 3 in Population 2ExperimentalParticipants will receive Dose 3 of HZN-1116
Receives: Drug: HZN-1116
HZN-1116 Dose 4 in Population 2ExperimentalParticipants will receive Dose 4 of HZN-1116
Receives: Drug: HZN-1116
Placebo in Population 2Placebo comparatorParticipants will receive Placebo matched to HZN-1116
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)

    Measured: At Week 48

  2. Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)

    Measured: At Week 24

Secondary outcomes (23)

  1. Change from baseline in ESSDAI (Population #1)

    Measured: At Week 24

  2. Proportion of Participants achieving ESSDAI [5] response (Population #1)

    Measured: At Week 24 and Week 48

  3. Change from baseline in ESSPRI pain domain score (Population #1)

    Measured: At Week 24 and Week 48

  4. Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1)

    Measured: At Week 24 and Week 48

  5. Change from baseline in ESSPRI fatigue domain score (Population #1)

    Measured: At Week 24 and Week 48

  6. Change from baseline in DASPRI fatigue domain score (Population #1)

    Measured: At Week 24 and Week 48

  7. Change from baseline in ESSPRI dryness domain score (Population #1)

    Measured: At Week 24 and Week 48

  8. Change from baseline in DASSPRI dryness domain score (Population #1)

    Measured: At Week 24 and Week 48

  9. Change from baseline in tender joint count (TJC) (Population #1)

    Measured: At Week 24 and Week 48

  10. Change from baseline in swollen joint count (SJC) (Population #1)

    Measured: At Week 24 and Week 48

  11. Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1)

    Measured: At Week 24 and Week 48

  12. Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1)

    Measured: At Week 24 and Week 48

  13. Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1)

    Measured: At Week 24 and Week 48

  14. Change from baseline in DASPRI (Population #2)

    Measured: At Week 24

  15. Proportion of Participants achieving ESSPRI [1.5] response (Population #2)

    Measured: At Week 24

  16. Change from baseline in ESSPRI pain domain (Population #2)

    Measured: At Week 24

  17. Change from baseline in ESSPRI fatigue domain (Population #2)

    Measured: At Week 24

  18. Change from baseline in ESSPRI dryness domain (Population #2)

    Measured: At Week 24

  19. Change from baseline in SF-36 PCS Score (Population #2)

    Measured: At Week 24

  20. Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2)

    Measured: At Week 24

  21. Change from baseline in PROMIS-Fatigue SF-10a (Population #2)

    Measured: At Week 24

  22. Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2)

    Measured: Up to Week 60

  23. Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2)

    Measured: Up to Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start9 May 2024
  3. Primary completion28 Apr 2026
  4. Study completion28 Apr 2026

Why it stopped: The study was terminated by sponsor due to meeting pre-defined criteria for futility.

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06312020
Sponsor's protocol ID
HZNP-HZN-1116-201
Status last verified
May 2026
First submitted
16 Feb 2024
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HZN-1116 in people with Sjogren's Syndrome, run by Amgen at 66 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Poland, Spain, Argentina, Taiwan and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated by sponsor due to meeting pre-defined criteria for futility.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06312020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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