A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of HZN-1116 in Participants With Sjögren's Syndrome
Status: Active_not_recruiting
Location: See all (65) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Arizona Arthritis & Rheumatology Research-S Vineyard Ave
Mesa
Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd
Phoenix
California
Neurovations Research
Napa
Florida
Life Arc Research Centers Corp
Miami
IRIS Research and Development LLC
Plantation
Clinical Research of West Florida Inc - Tampa
Tampa
Georgia
Augusta University Medical Center-Augusta-1120 15th St
Augusta
Massachusetts
Tufts Medical Center - 800 Washington St - PPDS
Boston
North Carolina
DJL Clinical Research PLLC-431 N Wendover Rd
Charlotte
New York
Pioneer Clinical Research NY
New York
Pennsylvania
Altoona Center for Clinical Research - 175 Meadowbrook Ln
Duncansville
Tennessee
West Tennessee Research Institute
Jackson
Texas
Tekton Research, LLC - W Gate Blvd - Austin - PPDS
Austin
Prolato Clinical Research Center
Houston
R & H Clinical Research-777 S Fry Rd
Katy
Wisconsin
University Of Wisconsin - Madison
Madison
Other Locations
Argentina
Centro Privado de Medicina Familiar
Buenos Aires
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Buenos Aires
DOM Centro de Reumatología
Buenos Aires
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires
MR Medicina Reumatologica
San Fernando
Austria
LKH-Universitätsklinikum Graz - Auenbruggerplatz 15
Graz
Chile
Biomedica Research Group
Providencia
Prosalud y Cia Ltda.
Santiago
Centro de especialidades médicas Vanguardia
Temuco
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
Viña Del Mar
Colombia
Centro Integral de Reumatologia del Caribe S.A.S - CIRCARIBE S.A.S.
Barranquilla
Servimed S.A.S
Bucaramanga
AES - AS - Fundacion Centro de Investigacion Clinica - CIC
Medellín
Healthy Medical Center S.A.S.
Zipaquirá
France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier
Germany
Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh
Hamburg
Medizinische Hochschule Hannover
Hanover
Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7
Budapest
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
Debrecen
Italy
IRCCS Ospedale Galeazzi - Sant'Ambrogio
Milan
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Rome
Mexico
PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS
Guadalajara
Clinstile, S.A. de C.V.
Mexico City
Poland
Centrum Medyczne PROMED
Krakow
FutureMeds - Krakow - PPDS
Krakow
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
Malbork
Pratia Poznan - PPDS
Poznan
Prywatna Praktyka Lekarska Pawel Hrycaj
Poznan
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw
FutureMeds - Targowek - PPDS
Warsaw
Klinika Reuma Park sp . zoo Sp.k.
Warsaw
MICS Centrum Medyczne Warszawa - MICS - PPDS
Warsaw
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. El. Reicher- Spartanska 1
Warsaw
Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
Ponte De Lima
ULS de Santo António, EPE - Hospital de Santo António
Porto
Spain
Hospital Sanitas CIMA
Barcelona
Hospital General Universitario de Castellon
Castellon
Hospital Universitario Virgen de Las Nieves
Granada
Clinicas Gaias-Santiago
Santiago De Compostela
Hospital Quironsalud Sagrado Corazon
Seville
Hospital Universitario Virgen Macarena
Seville
Switzerland
Kantonsspital St. Gallen
Sankt Gallen
Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital - PPDS
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan
United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke
Time Frame
Start Date: 2024-05-09
Completion Date: 2026-11-24
Participants
Target number of participants: 209
Treatments
Experimental: HZN-1116 Dose 1 in Population 1
Participants will receive Dose 1 of HZN-1116
Experimental: HZN-1116 Dose 2 in Population 1
Participants will receive Dose 2 of HZN-1116
Placebo_comparator: Placebo in Population 1
Participants will receive Placebo matched to HZN-1116
Experimental: HZN-1116 Dose 1 in Population 2
Participants will receive Dose 1 of HZN-1116
Experimental: HZN-1116 Dose 2 in Population 2
Participants will receive Dose 2 of HZN-1116
Experimental: HZN-1116 Dose 3 in Population 2
Participants will receive Dose 3 of HZN-1116
Experimental: HZN-1116 Dose 4 in Population 2
Participants will receive Dose 4 of HZN-1116
Placebo_comparator: Placebo in Population 2
Participants will receive Placebo matched to HZN-1116
Related Therapeutic Areas
Sponsors
Leads: Amgen