Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
NCT ID: NCT05430854
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
155 participants
INTERVENTIONAL
2022-06-01
2023-10-31
Brief Summary
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Detailed Description
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Acquired from Horizon in 2024.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Daxdilimab
Daxdilimab injections over a total of 48 weeks.
Daxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.
Interventions
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Daxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have completed the treatment period in the RECAST SLE study.
* Women of childbearing potential must have a negative urine pregnancy test on Day 1.
* Nonsterilized male subjects who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Day 1 and until 3 months (approximately 5 half-lives) after receipt of the last dose.
Exclusion Criteria
* Participation in another clinical study with an IP during the RECAST SLE study period.
* Planned elective surgeries that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety.
* Any herpes zoster, cytomegalovirus, or Epstein-Barr virus infection that was not completely resolved prior to Visit 1.
* Clinically significant active infection at Visit 1, in the opinion of the Investigator.
* Pregnant or lactating females.
18 Years
72 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States
Clinical Research of West Florida Inc - Clearwater
Clearwater, 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
Emory University School of Medicine
Atlanta, Georgia, United States
Bluegrass Community Research Inc
Lexington, Kentucky, United States
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York, United States
DJL Clinical Research
Charlotte, North Carolina, United States
Paramount Medical Research and Consulting LLC
Middleburg Heights, Ohio, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
Spectrum Medical, Inc
Danville, Virginia, United States
Consultorios Médicos Dr. Doreski
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Clínica Adventista Belgrano
Estomba, Buenos Aires, Argentina
Framingham Centro Médico
La Plata, Buenos Aires, Argentina
Instituto CER S.A
Quilmes, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes SRL
Quilmes, Buenos Aires, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Consultorio de Investigaciones Reumatologicas
San Miguel de Tucumán, Tucumán Province, Argentina
Athens General Hospital 'G Gennimatas
Athens, , Greece
Laiko General Hospital of Athens
Athens, , Greece
University General Hospital of Larissa
Larissa, , Greece
Kianous Stavros
Thessaloniki, , Greece
Krishna Institute of Medical Sciences
Secunderabad, Andhra Pradesh, India
AES - AS - Panchshil Hospital - Ahmedabad
Ahmedabad, Gujarat, India
AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat
Surat, Gujarat, India
AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli
Hubli, Karnataka, India
Jasleen Hospital
Nagpur, Maharashtra, India
Centro de Investigación en Artritis y Osteoporosis
Mexicali, Estado de Baja California, Mexico
Morales Vargas Centro de Investigacion SC
León, Guanajuato, Mexico
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable
Guadalajara, Jalisco, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, Jalisco, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
San Miguel, Mexico City, Mexico
Centro Peninsular de Investigacion S.C.P
Mérida, Yucatán, Mexico
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, , Mexico
Centro de Estudios de Investigacion Basica Y Clinica SC
Jalisco, , Mexico
Consultorio de Reumatologia
Mexico City, , Mexico
Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne Plejady
Krakow, Lesser Poland Voivodeship, Poland
Pratia MCM
Krakow, Lesser Poland Voivodeship, Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, Lubusz Voivodeship, Poland
Medycyna Kliniczna Marzena Waszczak-Jeka
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne AMED
Warsaw, Masovian Voivodeship, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Centrym Medyczne AMED oddzial w Lodzi
Lodz, Łódź Voivodeship, Poland
Institute of Rheumatology Belgrade
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Hospital Universitario A Coruña
A Coruña, , Spain
National Taiwan University Hospital
Taipei, Province of China, Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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HZNP-DAX-204
Identifier Type: -
Identifier Source: org_study_id
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