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NCT06312020

PHASE2

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

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

209

Start Date

2024-05-09

Completion Date

2026-11-24

Last Updated

2025-10-24

Healthy Volunteers

Conditions

Sjogren's Syndrome

Interventions

DRUG

HZN-1116

Subcutaneous Administration

DRUG

Placebo

Subcutaneous Administration

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.

Locations (65)

Arizona Arthritis & Rheumatology Research-S Vineyard Ave

Mesa, Arizona, United States

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

Phoenix, Arizona, United States

Neurovations Research

Napa, California, United States

Life Arc Research Centers Corp

Miami, Florida, United States

IRIS Research and Development LLC

Plantation, Florida, United States

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, United States

Augusta University Medical Center-Augusta-1120 15th St

Augusta, Georgia, United States

Tufts Medical Center - 800 Washington St - PPDS

Boston, Massachusetts, United States

Pioneer Clinical Research NY

New York, New York, United States

DJL Clinical Research PLLC-431 N Wendover Rd

Charlotte, North Carolina, United States

Altoona Center for Clinical Research - 175 Meadowbrook Ln

Duncansville, Pennsylvania, United States

West Tennessee Research Institute

Jackson, Tennessee, United States

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

Austin, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

R & H Clinical Research-777 S Fry Rd

Katy, Texas, United States

University Of Wisconsin - Madison

Madison, Wisconsin, United States

MR Medicina Reumatologica

San Fernando, Buenos Aires, Argentina

DOM Centro de Reumatología

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Centro Privado de Medicina Familiar

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

LKH-Universitätsklinikum Graz - Auenbruggerplatz 15

Graz, Styria, Austria

Centro de especialidades médicas Vanguardia

Temuco, Región de la Araucanía, Chile

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Región de Valparaíso, Chile

Biomedica Research Group

Providencia, Región-MetropolitanadeSantiago, Chile

Prosalud y Cia Ltda.

Santiago, Región-MetropolitanadeSantiago, Chile

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

Barranquilla, Atlántico, Colombia

Healthy Medical Center S.A.S.

Zipaquirá, Cundinamarca, Colombia

Servimed S.A.S

Bucaramanga, Colombia

AES - AS - Fundacion Centro de Investigacion Clinica - CIC

Medellín, Colombia

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, Hérault, France

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

Hamburg, Germany

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar, Hungary

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

Budapest, Hungary

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, Italy

IRCCS Ospedale Galeazzi - Sant'Ambrogio

Milan, Lombardy, Italy

PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS

Guadalajara, Jalisco, Mexico

Clinstile, S.A. de C.V.

Mexico City, Mexico

Pratia Poznan - PPDS

Poznan, Greater Poland Voivodeship, Poland

Prywatna Praktyka Lekarska Pawel Hrycaj

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne PROMED

Krakow, Lesser Poland Voivodeship, Poland

MICS Centrum Medyczne Warszawa - MICS - PPDS