A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome
- Registration Number
- NCT06312020
- Lead 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 262
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo in Population 2 Placebo Participants will receive Placebo matched to HZN-1116 HZN-1116 Dose 1 in Population 1 HZN-1116 Participants will receive Dose 1 of HZN-1116 HZN-1116 Dose 1 in Population 2 HZN-1116 Participants will receive Dose 1 of HZN-1116 Placebo in Population 1 Placebo Participants will receive Placebo matched to HZN-1116 HZN-1116 Dose 4 in Population 2 HZN-1116 Participants will receive Dose 4 of HZN-1116 HZN-1116 Dose 2 in Population 1 HZN-1116 Participants will receive Dose 2 of HZN-1116 HZN-1116 Dose 2 in Population 2 HZN-1116 Participants will receive Dose 2 of HZN-1116 HZN-1116 Dose 3 in Population 2 HZN-1116 Participants will receive Dose 3 of HZN-1116
- Primary Outcome Measures
Name Time Method Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1) At Week 48 Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2) At Week 24
- Secondary Outcome Measures
Name Time Method Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2) Up to Week 60 Change from baseline in ESSDAI (Population #1) At Week 24 Proportion of Participants achieving ESSDAI [5] response (Population #1) At Week 24 and Week 48 Change from baseline in ESSPRI pain domain score (Population #1) At Week 24 and Week 48 Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1) At Week 24 and Week 48 Change from baseline in ESSPRI fatigue domain score (Population #1) At Week 24 and Week 48 Change from baseline in DASPRI fatigue domain score (Population #1) At Week 24 and Week 48 Change from baseline in ESSPRI dryness domain score (Population #1) At Week 24 and Week 48 Change from baseline in DASSPRI dryness domain score (Population #1) At Week 24 and Week 48 Change from baseline in tender joint count (TJC) (Population #1) At Week 24 and Week 48 Change from baseline in swollen joint count (SJC) (Population #1) At Week 24 and Week 48 Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1) At Week 24 and Week 48 Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1) At Week 24 and Week 48 Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1) At Week 24 and Week 48 Change from baseline in DASPRI (Population #2) At Week 24 Proportion of Participants achieving ESSPRI [1.5] response (Population #2) At Week 24 Change from baseline in ESSPRI pain domain (Population #2) At Week 24 Change from baseline in ESSPRI fatigue domain (Population #2) At Week 24 Change from baseline in ESSPRI dryness domain (Population #2) At Week 24 Change from baseline in SF-36 PCS Score (Population #2) At Week 24 Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2) At Week 24 Change from baseline in PROMIS-Fatigue SF-10a (Population #2) At Week 24 Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2) Up to Week 60
Trial Locations
- Locations (82)
Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
🇺🇸Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research-S Vineyard Ave
🇺🇸Mesa, Arizona, United States
Neurovations Research
🇺🇸Napa, California, United States
Life Arc Research Centers Corp
🇺🇸Miami, Florida, United States
Millennium Research
🇺🇸Ormond Beach, Florida, United States
IRIS Research and Development LLC
🇺🇸Plantation, Florida, United States
Clinical Research of West Florida Inc - Tampa
🇺🇸Tampa, Florida, United States
Accurate Clinical Research - Lake Charles
🇺🇸Lake Charles, Louisiana, United States
Columbia Medical Practice
🇺🇸Columbia, Maryland, 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
Trio Clinical Trials - 1235 North Loop West
🇺🇸Houston, 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 ReumatologÃa
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Expertia S.A- Mautalén Salud e Investigación
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Centro Privado de Medicina Familiar
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Consultorios Médicos Dr. Doreski - PPDS
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
Sanatorio 9 de Julio S.A.
🇦🇷San Miguel De Tucumán, Tucumán, Argentina
LKH-Universitätsklinikum Graz - Auenbruggerplatz 15
🇦🇹Graz, Steiermark, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Medical Center Excelsior OOD - PPDS
🇧🇬Sofia, Sofia-Grad, Bulgaria
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
🇧🇬Sofia, Sofia-Grad, Bulgaria
Medical Center Artmed OOD
🇧🇬Plovdiv, Bulgaria
Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris OOD
🇧🇬Plovdiv, Bulgaria
Centro de especialidades médicas Vanguardia
🇨🇱Temuco, AraucanÃa, Chile
Biomedica Research Group
🇨🇱Providencia, Región-MetropolitanadeSantiago, Chile
Prosalud
🇨🇱Santiago, Región-MetropolitanadeSantiago, Chile
Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
🇨🇱Viña del Mar, ValparaÃso, Chile
CHU de Bordeaux - Hôpital Pellegrin
🇫🇷Bordeaux, Gironde, France
CHU de Strasbourg - Hôpital de Hautepierre
🇫🇷Strasbourg, France
CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
🇫🇷Toulouse, France
Medizinische Hochschule Hannover
🇩🇪Hannover, Niedersachsen, Germany
Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh
🇩🇪Hamburg, Germany
Laiko General Hospital of Athens
🇬🇷Athina, Attiki, Greece
General Hospital of Athens ''G. Gennimatas''
🇬🇷Athina, Attiki, Greece
General Hospital ''Asklepieio Voulas''
🇬🇷Voula, Attiki, Greece
Euromedica Kianous Stavros
🇬🇷Thessaloniki, Greece
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
ðŸ‡ðŸ‡ºDebrecen, Hajdú-Bihar, Hungary
Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Szent Laszlo Korhaz Teleph
ðŸ‡ðŸ‡ºBudapest, Hungary
Beaumont Hospital
🇮🇪Dublin 9, Dublin, Ireland
Our Lady's Community Hospital
🇮🇪Manorhamilton, Ireland
Fondazione Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Lazio, Italy
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
🇮🇹Roma, Lazio, Italy
IRCCS Ospedale Galeazzi - Sant'Ambrogio
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
🇮🇹Pisa, Toscana, Italy
ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini
🇮🇹Milano, Italy
PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS
🇲🇽Guadalajara, Jalisco, Mexico
Clinstile, S.A. de C.V.
🇲🇽Mexico City, Mexico
Centrum Medyczne PROMED
🇵🇱Kraków, Malopolskie, Poland
MICS Centrum Medyczne Warszawa - MICS - PPDS
🇵🇱Warszawa, Mazowieckie, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. El. Reicher- Spartanska 1
🇵🇱Warszawa, Mazowieckie, Poland
Klinika Reuma Park sp . zoo Sp.k.
🇵🇱Warszawa, Mazowieckie, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
🇵🇱Warszawa, Mazowieckie, Poland
FutureMeds - Targowek - PPDS
🇵🇱Warszawa, Mazowieckie, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
🇵🇱Malbork, Pomorskie, Poland
Prywatna Praktyka Lekarska Pawel Hrycaj
🇵🇱Poznan, Wielkopolskie, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
🇵🇱Poznan, Wielkopolskie, Poland
Pratia Poznan - PPDS
🇵🇱Poznań, Wielkopolskie, Poland
Krakowskie Centrum Medyczne - FutureMeds - PPDS
🇵🇱Kraków, Poland
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
🇵🇹Lisboa, Portugal
Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
🇵🇹Ponte De Lima, Portugal
ULS de Santo António, EPE - Hospital de Santo António
🇵🇹Porto, Portugal
Hospital Sanitas CIMA
🇪🇸Barcelona, Spain
Hospital General Universitario de Castellon
🇪🇸Castellón, Spain
Hospital Universitario Virgen de Las Nieves
🇪🇸Granada, Spain
Clinicas Gaias-Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Quironsalud Sagrado Corazon
🇪🇸Sevilla, Spain
Kantonsspital St. Gallen
🇨ðŸ‡St Gallen, Switzerland
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung City, Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Taipei Medical University Hospital - PPDS
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan City, Taiwan
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, Hampshire, United Kingdom