Clinical trial NCT06312020: A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sjogren's Syndrome
Keywords: SS
Sjogren's
HZN-1116
Autoimmune disease
Dry Eye syndrome
VIB1116
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)
timeFrame: At Week 48
measure: Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)
timeFrame: At Week 24
Secondary outcomes:
measure: Change from baseline in ESSDAI (Population #1)
timeFrame: At Week 24
measure: Proportion of Participants achieving ESSDAI [5] response (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in ESSPRI pain domain score (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in ESSPRI fatigue domain score (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in DASPRI fatigue domain score (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in ESSPRI dryness domain score (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in DASSPRI dryness domain score (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in tender joint count (TJC) (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in swollen joint count (SJC) (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in 36-item Short Form Survey (SF-36) physical component score (PCS) (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score (MCS) (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in patient-reported outcomes measurement information system (PROMIS)-Fatigue SF-10a (Population #1)
timeFrame: At Week 24 and Week 48
measure: Change from baseline in DASPRI (Population #2)
timeFrame: At Week 24
measure: Proportion of Participants achieving ESSPRI [1.5] response (Population #2)
timeFrame: At Week 24
measure: Change from baseline in ESSPRI pain domain (Population #2)
timeFrame: At Week 24
measure: Change from baseline in ESSPRI fatigue domain (Population #2)
timeFrame: At Week 24
measure: Change from baseline in ESSPRI dryness domain (Population #2)
timeFrame: At Week 24
measure: Change from baseline in SF-36 PCS Score (Population #2)
timeFrame: At Week 24
measure: Change from baseline in 36-item Short Form Survey (SF-36) mental component score MCS (Population #2)
timeFrame: At Week 24
measure: Change from baseline in PROMIS-Fatigue SF-10a (Population #2)
timeFrame: At Week 24
measure: Serum concentration of HZN-1116 starting at Week 1 through study completion (Population #1 and #2)
timeFrame: Up to Week 60
measure: Proportion of Participants who develop anti drug antibodies (ADA) over time (Population #1 and #2)
timeFrame: Up to Week 60
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Arthritis and Rheumatology Associates - Glendale - 5681 W Beverly Ln
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research-S Vineyard Ave
state: Arizona
city: Napa
country: United States
facility: Neurovations Research
state: California
city: Miami
country: United States
facility: Life Arc Research Centers Corp
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development LLC
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida Inc - Tampa
state: Florida
city: Lake Charles
country: United States
facility: Accurate Clinical Research - Lake Charles
state: Louisiana
city: Columbia
country: United States
facility: Columbia Medical Practice
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center - 800 Washington St - PPDS
state: Massachusetts
city: New York
country: United States
facility: Pioneer Clinical Research NY
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research PLLC-431 N Wendover Rd
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research - 175 Meadowbrook Ln
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, LLC - W Gate Blvd - Austin - PPDS
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials - 1235 North Loop West
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Katy
country: United States
facility: R & H Clinical Research-777 S Fry Rd
state: Texas
city: Madison
country: United States
facility: University Of Wisconsin - Madison
state: Wisconsin
city: San Fernando
country: Argentina
facility: MR Medicina Reumatologica
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: DOM Centro de Reumatología
state: Ciudad Autónoma De BuenosAires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalén Salud e Investigación
state: Ciudad Autónoma De BuenosAires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
state: Ciudad Autónoma De BuenosAires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Consultorios Médicos Dr. Doreski - PPDS
state: Ciudad Autónoma De BuenosAires
city: San Miguel De Tucumán
country: Argentina
facility: Sanatorio 9 de Julio S.A.
state: Tucumán
city: Graz
country: Austria
facility: LKH-Universitätsklinikum Graz - Auenbruggerplatz 15
state: Steiermark
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD - PPDS
state: Sofia-Grad
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
state: Sofia-Grad
city: Plovdiv
country: Bulgaria
facility: Medical Center Artmed OOD
city: Plovdiv
country: Bulgaria
facility: Outpatient Clinic for Specialized Medical Help - Medical Center Kuchuk Paris OOD
city: Temuco
country: Chile
facility: Centro de especialidades médicas Vanguardia
state: Araucanía
city: Providencia
country: Chile
facility: Biomedica Research Group
state: Región-MetropolitanadeSantiago
city: Santiago
country: Chile
facility: Prosalud
state: Región-MetropolitanadeSantiago
city: Viña del Mar
country: Chile
facility: Centro de Investigacion de Enfermedades Respiratorias e inmunologicas
state: Valparaíso
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Pellegrin
state: Gironde
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
state: Hérault
city: Strasbourg
country: France
facility: CHU de Strasbourg - Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU de Toulouse-Hôpital Pierre-Paul Riquet-Site de Purpan
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Hamburg
country: Germany
facility: Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
state: Attiki
city: Athina
country: Greece
facility: General Hospital of Athens ''G. Gennimatas''
state: Attiki
city: Athina
country: Greece
facility: Laiko General Hospital of Athens
state: Attiki
city: Voula
country: Greece
facility: General Hospital ''Asklepieio Voulas''
state: Attiki
city: Thessaloniki
country: Greece
facility: Euromedica Kianous Stavros
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
state: Hajdú-Bihar
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Szent Laszlo Korhaz Teleph
city: Dublin 9
country: Ireland
facility: Beaumont Hospital
state: Dublin
city: Manorhamilton
country: Ireland
facility: Our Lady's Community Hospital
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
state: Lazio
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
state: Lazio
city: Milano
country: Italy
facility: IRCCS Ospedale Galeazzi - Sant'Ambrogio
state: Lombardia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
state: Toscana
city: Milano
country: Italy
facility: ASST Gaetano Pini - Presidio Ospedaliero Gaetano Pini
city: Guadalajara
country: Mexico
facility: PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS
state: Jalisco
city: Mexico City
country: Mexico
facility: Clinstile, S.A. de C.V.
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED
state: Malopolskie
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa - MICS - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. El. Reicher- Spartanska 1
state: Mazowieckie
city: Warszawa
country: Poland
facility: Klinika Reuma Park sp . zoo Sp.k.
state: Mazowieckie
city: Warszawa
country: Poland
facility: AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie
state: Mazowieckie
city: Warszawa
country: Poland
facility: FutureMeds - Targowek - PPDS
state: Mazowieckie
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.
state: Pomorskie
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Pawel Hrycaj
state: Wielkopolskie
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
state: Wielkopolskie
city: Poznań
country: Poland
facility: Pratia Poznan - PPDS
state: Wielkopolskie
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne - FutureMeds - PPDS
city: Lisboa
country: Portugal
facility: ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
city: Ponte De Lima
country: Portugal
facility: Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima
city: Porto
country: Portugal
facility: ULS de Santo António, EPE - Hospital de Santo António
city: Barcelona
country: Spain
facility: Hospital Sanitas CIMA
city: Castellón
country: Spain
facility: Hospital General Universitario de Castellon
city: Granada
country: Spain
facility: Hospital Universitario Virgen de Las Nieves
city: Santiago de Compostela
country: Spain
facility: Clinicas Gaias-Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Quironsalud Sagrado Corazon
city: St Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital - PPDS
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
state: Hampshire
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: