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A Phase 2 Study to Investigat...

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

NCT ID: NCT06312020

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-09

Study Completion Date

2026-11-24

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HZN-1116 Dose 1 in Population 1

Participants will receive Dose 1 of HZN-1116

Group Type EXPERIMENTAL

HZN-1116

Intervention Type DRUG

Subcutaneous Administration

HZN-1116 Dose 2 in Population 1

Participants will receive Dose 2 of HZN-1116

Group Type EXPERIMENTAL

HZN-1116

Intervention Type DRUG

Subcutaneous Administration

Placebo in Population 1

Participants will receive Placebo matched to HZN-1116

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous Administration

HZN-1116 Dose 1 in Population 2

Participants will receive Dose 1 of HZN-1116

Group Type EXPERIMENTAL

HZN-1116

Intervention Type DRUG

Subcutaneous Administration

HZN-1116 Dose 2 in Population 2

Participants will receive Dose 2 of HZN-1116

Group Type EXPERIMENTAL

HZN-1116

Intervention Type DRUG

Subcutaneous Administration

HZN-1116 Dose 3 in Population 2

Participants will receive Dose 3 of HZN-1116

Group Type EXPERIMENTAL

HZN-1116

Intervention Type DRUG

Subcutaneous Administration

HZN-1116 Dose 4 in Population 2

Participants will receive Dose 4 of HZN-1116

Group Type EXPERIMENTAL

HZN-1116

Intervention Type DRUG

Subcutaneous Administration

Placebo in Population 2

Participants will receive Placebo matched to HZN-1116

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous Administration

Interventions

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HZN-1116

Subcutaneous Administration

Intervention Type DRUG

Placebo

Subcutaneous Administration

Intervention Type DRUG

Other Intervention Names

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VIB1116 AMG 329 Adezkibart

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Arizona Arthritis & Rheumatology Research-S Vineyard Ave

Mesa, Arizona, United States

Site Status

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

Phoenix, Arizona, United States

Site Status

Neurovations Research

Napa, California, United States

Site Status

Life Arc Research Centers Corp

Miami, Florida, United States

Site Status

IRIS Research and Development LLC

Plantation, Florida, United States

Site Status

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, United States

Site Status

Augusta University Medical Center-Augusta-1120 15th St

Augusta, Georgia, United States

Site Status

Tufts Medical Center - 800 Washington St - PPDS

Boston, Massachusetts, United States

Site Status

Pioneer Clinical Research NY

New York, New York, United States

Site Status

DJL Clinical Research PLLC-431 N Wendover Rd

Charlotte, North Carolina, United States

Site Status

Altoona Center for Clinical Research - 175 Meadowbrook Ln

Duncansville, Pennsylvania, United States

Site Status

West Tennessee Research Institute

Jackson, Tennessee, United States

Site Status

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

Austin, Texas, United States

Site Status

Prolato Clinical Research Center

Houston, Texas, United States

Site Status

R & H Clinical Research-777 S Fry Rd

Katy, Texas, United States

Site Status

University Of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status

MR Medicina Reumatologica

San Fernando, Buenos Aires, Argentina

Site Status

DOM Centro de Reumatología

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Site Status

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Site Status

Centro Privado de Medicina Familiar

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Site Status

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Site Status

LKH-Universitätsklinikum Graz - Auenbruggerplatz 15

Graz, Styria, Austria

Site Status

Centro de especialidades médicas Vanguardia

Temuco, Región de la Araucanía, Chile

Site Status

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Región de Valparaíso, Chile

Site Status

Biomedica Research Group

Providencia, Región-MetropolitanadeSantiago, Chile

Site Status

Prosalud y Cia Ltda.

Santiago, Región-MetropolitanadeSantiago, Chile

Site Status

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

Barranquilla, Atlántico, Colombia

Site Status

Healthy Medical Center S.A.S.

Zipaquirá, Cundinamarca, Colombia

Site Status

Servimed S.A.S

Bucaramanga, , Colombia

Site Status

AES - AS - Fundacion Centro de Investigacion Clinica - CIC

Medellín, , Colombia

Site Status

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, Hérault, France

Site Status

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Site Status

Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

Hamburg, , Germany

Site Status

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar, Hungary

Site Status

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

Budapest, , Hungary

Site Status

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, Italy

Site Status

IRCCS Ospedale Galeazzi - Sant'Ambrogio

Milan, Lombardy, Italy

Site Status

PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS

Guadalajara, Jalisco, Mexico

Site Status

Clinstile, S.A. de C.V.

Mexico City, , Mexico

Site Status

Pratia Poznan - PPDS

Poznan, Greater Poland Voivodeship, Poland

Site Status

Prywatna Praktyka Lekarska Pawel Hrycaj

Poznan, Greater Poland Voivodeship, Poland

Site Status