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NCT06312020 | RECRUITING | Sjogren's Syndrome

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

Amgen

Brief Summary:

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

Condition or disease

Sjogren's syndrome

Intervention/treatment

HZN-1116

Placebo

Phase

PHASE2

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
Estimated Enrollment : 262 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-05-09
Estimated Primary Completion Date : 2026-06-02
Estimated Study Completion Date : 2027-02-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

Location Details

NCT06312020

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Arizona Arthritis & Rheumatology Research-S Vineyard Ave

Mesa, Arizona, United States, 85210-6871

RECRUITING

United States, Arizona

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

Phoenix, Arizona, United States, 85032-9306

RECRUITING

United States, California

Neurovations Research

Napa, California, United States, 94558-2415

RECRUITING

United States, Florida

Life Arc Research Centers Corp

Miami, Florida, United States, 33126

RECRUITING

United States, Florida

Millennium Research

Ormond Beach, Florida, United States, 32174-1140

RECRUITING

United States, Florida

IRIS Research and Development LLC

Plantation, Florida, United States, 33324-2736

RECRUITING

United States, Florida

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, United States, 33606-1246

RECRUITING

United States, Louisiana

Accurate Clinical Research - Lake Charles

Lake Charles, Louisiana, United States, 70605-5393

RECRUITING

United States, Maryland

Columbia Medical Practice

Columbia, Maryland, United States, 21045

RECRUITING

United States, Massachusetts

Tufts Medical Center - 800 Washington St - PPDS

Boston, Massachusetts, United States, 02111-1552

RECRUITING

United States, New York

Pioneer Clinical Research NY

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

RECRUITING

United States, North Carolina

DJL Clinical Research PLLC-431 N Wendover Rd

Charlotte, North Carolina, United States, 28211-1064

RECRUITING

United States, Pennsylvania

Altoona Center for Clinical Research - 175 Meadowbrook Ln

Duncansville, Pennsylvania, United States, 16635-8445

RECRUITING

United States, Tennessee

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305-2883

RECRUITING

United States, Texas

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

Austin, Texas, United States, 78745

RECRUITING

United States, Texas

Prolato Clinical Research Center

Houston, Texas, United States, 77054-2853

RECRUITING

United States, Texas

R & H Clinical Research-777 S Fry Rd

Katy, Texas, United States, 77450-2297

RECRUITING

United States, Wisconsin

University Of Wisconsin - Madison

Madison, Wisconsin, United States, 53792-0001

RECRUITING

Argentina, Buenos Aires

Mr rheumatological medicine

San Fernando, Buenos Aires, Argentina, B1646GHP

RECRUITING

Argentina, Autonomous City of Buenos Aires

Dom Rheumatology Center

Autonomous City of Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1107

RECRUITING

Argentina, Autonomous City of Buenos Aires

EXPERTIA S.A- MAUTALÉN HEALTH AND RESEARCH

Autonomous City of Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1128Aaf

RECRUITING

Argentina, Autonomous City of Buenos Aires

Private Center for Family Medicine

Autonomous City of Buenos Aires, Autonomous City of Buenos Aires, Argentina, C 1417

RECRUITING

Argentina, Autonomous City of Buenos Aires

Medical Offices Dr. Doreski - PPDS

Autonomous City of Buenos Aires, Autonomous City of Buenos Aires, Argentina, C1426ABP

RECRUITING

Argentina, Tucumán

Sanatorio 9 de Julio S.A.

San Miguel de Tucumán, Tucumán, Argentina, T4000DGF

RECRUITING

Austria, Styria

LKH University Clinic Graz - Auenbruggerplatz 15

Graz, Styria, Austria, 8036

RECRUITING

Austria,

Medical University of Vienna

Wien, Austria, 1090

RECRUITING

Bulgaria, Sofia degree

Medical Center Excelsior OOD - PPDS

Sofia, Sofia degree, Bulgaria, 1421

RECRUITING

Bulgaria, Sofia degree

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia degree, Bulgaria, 1606

RECRUITING

Bulgaria,

Medical Center Artmed OOD

Plovdiv, Bulgaria, 4002

RECRUITING

Bulgaria,

Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris OOD

Plovdiv, Bulgaria, 4004

RECRUITING

Chile, Araucanía

Vanguardia Medical Specialties Center

Temuco, Araucanía, Chile, 4780000

RECRUITING

Chile, Region-meterpolitasantiago

Biomedica Research Group

Providence, Region-meterpolitasantiago, Chile, 7500000

RECRUITING

Chile, Region-meterpolitasantiago

Prosalud

Santiago, Region-meterpolitasantiago, Chile, 7510047

RECRUITING

Chile, Valparaíso

Respiratory and Immunological Disease Research Center

Viña del Mar, Valparaíso, Chile, 2531172

RECRUITING

France, Gironde

CHU de Bordeaux - Pellegrin Hospital

Bordeaux, Gironde, France, 33076

RECRUITING

France, Hérault

CHU de Montpellier - Lapeyronie Hospital

Montpellier, Hérault, France, 34295

RECRUITING

France,

Strasbourg University Hospital - Hautepierre Hospital

Strasbourg, France, 67200

RECRUITING

France,

CHU of Toulouse-Hospital Pierre-Paul Riquet-Site de Purpan

Toulouse, France, 31059

RECRUITING

Germany, Lower Saxony

Medical University of Hanover

Hannover, Lower Saxony, Germany, 30625

RECRUITING

Germany,

MVZ Rheumatology and Autoimmun Medicine Hamburg GmbH

Hamburg, Germany, 20095

RECRUITING

Greece, Attica

Laiko General Hospital of Athens

Athens, Attica, Greece, 115 27

RECRUITING

Greece, Attica

General Hospital of Athens ''G. Gennimatas''

Athens, Attica, Greece, 115 27

RECRUITING

Greece, Attica

Laiko General Hospital of Athens

Athens, Attica, Greece, 115 27

RECRUITING

Greece, Attica

General Hospel '' Asclepius Voula ''

Wig, Attica, Greece, 166 73

RECRUITING

Greece,

Euromedica Kianous Stavros

Thessaloniki, Greece, 546 36

RECRUITING

Hungary, Hajdú-Bihar

University of Debrecen Clinical Cosm Great Forest Campus

Debrecen, Hajdú-Bihar, Hungary, 4032

RECRUITING

Hungary,

Del-Pest Centrum Korhaz- Orszagos Hematological and Infectolic Institution- St. Laszlo Korhaz Telep

Budapest, Hungary, 1097

RECRUITING

Ireland, Dublin

Beaumont Hospital

Dublin 9, Dublin, Ireland, D09 XR63

RECRUITING

Ireland,

Our Lady's Community Hospital

Manorhamilton, Ireland, F91

RECRUITING

Italy, Lazio

BIO-Medical Polyclinic University Polyclinic Foundation

Roma, Lazio, Italy, 00128

RECRUITING

Italy, Lazio

University Polyclinic Foundation in Gemelli - Rome - PPDS

Roma, Lazio, Italy, 00168

RECRUITING

Italy, Lombardy

IRCCS Galeazzi Hospital - Sant'Ambrogio

Milano, Lombardy, Italy, 20157

RECRUITING

Italy, Tuscany

Pisan University Hospital - Santa Chiara plant

Pisa, Tuscany, Italy, 56126

RECRUITING

Italy,

ASST Gaetano Pini - Gaetano Pini hospital garrison

Milano, Italy, 20122

RECRUITING

Mexico, Jalisco

Panamerican Clinical Research - Domingo Sarmiento 2784 - PPDS

Guadalajara, Jalisco, Mexico, 44670

RECRUITING

Mexico,

Clinstile, S.A. by C.V.

Mexico City, Mexico, C.P. 06700

RECRUITING

Poland, Lesopolskie

Promed Medical Center

Cracow, Lesopolskie, Poland, 31-513

RECRUITING

Poland, Masovian

MICS Medical Center Warsaw - MICS - PPDS

Warsaw, Masovian Voivodeship, Poland, 00-874

RECRUITING

Poland, Masovian

National Institute of Geriatrics, Rheumatology and Rehabilitation Prof. El. Reicher-Spartanska 1

Warsaw, Masovian Voivodeship, Poland, 02-637

RECRUITING

Poland, Masovian

Reuma Parks Clinic . Sp.k.

Warsaw, Masovian Voivodeship, Poland, 02-665

RECRUITING

Poland, Masovian

AES - DRS - Synexus Polska Sp. z o.o. Departure in Warsaw

Warsaw, Masovian Voivodeship, Poland, 02-672

RECRUITING

Poland, Masovian

FutureMeds - Targowek - PPDS

Warsaw, Masovian Voivodeship, Poland, 03-291

RECRUITING

Poland, Pomeranian

Research Center Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.

Malbork, Pomeranian, Poland, 82-200

RECRUITING

Poland, Greater Poland

Private Medical Practice Pawel Hrycaj

Poznan, Greater Poland, Poland, 61-397

RECRUITING

Poland, Greater Poland

University Clinical Hospital in Poznań

Poznan, Greater Poland, Poland, 61-848

RECRUITING

Poland, Greater Poland

Pratia Poznan - PPDS

Poznań, Greater Poland, Poland, 60-192

RECRUITING

Poland,

Krakow Medical Center - Futuremeds - PPDS

Cracow, Poland, 31-501

RECRUITING

Portugal,

Uns de Santa Maria, Epe - Hospital de Santa Maria - ppds

Lisboa, Portugal, 1649-035

RECRUITING

Portugal,

Conde de Bertiandos Hospital - Local Health Unit of Alto Minho, EPE - Ponte de Lima

Ponte de Lima, Portugal, 4990-041

RECRUITING

Portugal,

ULS de Santo António, EPE - Santo António Hospital

Porto, Portugal, 4099-001

RECRUITING

Spain,

Sanitas Hospital Up

Barcelona, Spain, 08034

RECRUITING

Spain,

Castellon University General Hospital

Castellón, Spain, 12004

RECRUITING

Spain,

Virgen de las Nieves University Hospital

Granada, Spain, 18014

RECRUITING

Spain,

Gaias-Santiago clinics

Santiago de Compostela, Spain, 15702

RECRUITING

Spain,

Virgen Macarena University Hospital

Sevilla, Spain, 41009

RECRUITING

Spain,

Quironsalud Sacred Heart Hospital

Sevilla, Spain, 41013

RECRUITING

Switzerland,

Cantonal Hospital St. Gallen

St Gallen, Switzerland, 9007

RECRUITING

Taiwan,

Kaohsiung Veterans General Hospital

City fast, Taiwan, 81362

RECRUITING

Taiwan,

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

City fast, Taiwan, 83301

RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei City, Taiwan, 10002

RECRUITING

Taiwan,

Taipei Medical University Hospital - PPDS

Taipei, Taiwan, 11031

RECRUITING

Taiwan,

Chang Gung Memorial Hospital, Linkou

Taoyuan City, Taiwan, 33305

RECRUITING

United Kingdom, Hampshire

Basingstoke and North Hampshire Hospital

Basingstoke, Hampshire, United Kingdom, RG24 Yana