Clinical trial NCT05430854: Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
Official title: An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 2, Open-Label Extension study to evaluate the long-term safety and tolerability of daxdilimab in participants with Systemic Lupus Erythematosus completing the treatment period of the RECAST SLE clinical study.

Detailed description: Approximately 156 participants will be enrolled to receive daxdilimab administered subcutaneously over 48 weeks. The maximum trial duration per participant is approximately 56 weeks, including the 48 weeks for the open-label treatment period where participants will receive daxdilimab and approximately 8 weeks for the follow-up period. Safety evaluations will be performed regularly throughout the course of the study.

Acquired from Horizon in 2024.

Eligibility criteria: Inclusion Criteria:

* Willing and able to understand and provide written informed consent.
* 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:

* Any condition or change during the RECAST SLE study that in the opinion of the Investigator or the Sponsor would interfere with evaluation and interpretation of subject safety or alter the risk-benefit associated with IP administration.
* 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.

Primary outcomes:
measure: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 56 weeks
measure: Number of Participants Who Experienced Serious Adverse Events (SAEs)
timeFrame: Up to approximately 56 weeks
measure: Number of Participants Who Experienced AEs of Special Interest (AESI)
timeFrame: Up to approximately 56 weeks
Secondary outcomes:
measure: Serum Concentration of Daxdilimab
timeFrame: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
measure: Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
timeFrame: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56
measure: Number of Participants Expressing Anti-drug Antibodies (ADA)
timeFrame: Up to approximately 56 weeks
Other outcomes:
Locations:
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Incorporated
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida Inc - Clearwater
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: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Lexington
country: United States
facility: Bluegrass Community Research Inc
state: Kentucky
city: Brooklyn
country: United States
facility: NYU Langone Ambulatory Care Brooklyn Heights
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research and Consulting LLC
state: Ohio
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc
state: Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Consultorios Médicos Dr. Doreski
state: Buenos Aires
city: Estomba
country: Argentina
facility: Clínica Adventista Belgrano
state: Buenos Aires
city: La Plata
country: Argentina
facility: Framingham Centro Médico
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto CER S.A
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes SRL
state: Buenos Aires
city: San Miguel De Tucumán
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucumán
city: San Miguel De Tucumán
country: Argentina
facility: Consultorio de Investigaciones Reumatologicas
state: Tucumán
city: Athens
country: Greece
facility: Athens General Hospital 'G Gennimatas
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Larisa
country: Greece
facility: University General Hospital of Larissa
city: Thessaloníki
country: Greece
facility: Kianous Stavros
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: AES - AS - Panchshil Hospital - Ahmedabad
state: Gujarat
city: Sūrat
country: India
facility: AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat
state: Gujarat
city: Hubli
country: India
facility: AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli
state: Karnataka
city: Nagpur
country: India
facility: Jasleen Hospital
state: Maharashtra
city: Mexicali
country: Mexico
facility: Centro de Investigación en Artritis y Osteoporosis
state: Baja California
city: San Miguel
country: Mexico
facility: Centro de Investigación y Tratamiento Reumatológico S.C
state: Distrito Federal
city: León
country: Mexico
facility: Morales Vargas Centro de Investigacion SC
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable
state: Jalisco
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
state: Jalisco
city: Merida
country: Mexico
facility: Centro Peninsular de Investigacion S.C.P
state: Yucatán
city: Ciudad de Mexico
country: Mexico
facility: Consultorio de Reumatologia
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad
city: Jalisco
country: Mexico
facility: Centro de Estudios de Investigacion Basica Y Clinica SC
city: Łódź
country: Poland
facility: Centrym Medyczne AMED oddzial w Lodzi
state: Lodzkie
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
state: Lubuskie
city: Krakow
country: Poland
facility: Pratia MCM
state: Malopolskie
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
state: Malopolskie
city: Warszawa
country: Poland
facility: Medycyna Kliniczna Marzena Waszczak-Jeka
state: Mazowieckie
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
state: Mazowieckie
city: Poznań
country: Poland
facility: Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
state: Wielkopolskie
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Belgrade
country: Serbia
facility: Institute of Rheumatology Belgrade
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Province Of China
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: