Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study (RECAST SLE OLE)

An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus

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.

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: Daxdilimab

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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
      • Consultorios Médicos Dr. Doreski
    • Estomba, Buenos Aires, Argentina, C1430EGF
      • Clinica Adventista Belgrano
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Framingham Centro Médico
    • Quilmes, Buenos Aires, Argentina, B1878GEG
      • Instituto de Investigaciones Clinicas Quilmes SRL
    • Quilmes, Buenos Aires, Argentina, B1878DVB
      • Instituto CER S.A
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
      • Centro Medico Privado de Reumatologia
    • San Miguel De Tucumán, Tucumán, Argentina, T4000AXL
      • Consultorio de Investigaciones Reumatologicas
• Greece
  • Athens, Greece, 115 27
    • Laiko General Hospital of Athens
  • Athens, Greece, 115 27
    • Athens General Hospital 'G Gennimatas
  • Larisa, Greece, 411 10
    • University General Hospital of Larissa
  • Thessaloníki, Greece, 546 36
    • Kianous Stavros
• India
  • Andhra Pradesh
    • Secunderabad, Andhra Pradesh, India, 500003
      • Krishna Institute of Medical Sciences
  • Gujarat
    • Ahmedabad, Gujarat, India, 380005
      • AES - AS - Panchshil Hospital - Ahmedabad
    • Sūrat, Gujarat, India, 395010
      • AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat
  • Karnataka
    • Hubli, Karnataka, India, 580021
      • AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli
  • Maharashtra
    • Nagpur, Maharashtra, India, 440012
      • Jasleen Hospital
• Mexico
  • Ciudad de Mexico, Mexico, 07760
    • Consultorio de Reumatologia
  • Guadalajara, Mexico, 44600
    • Clinica de Investigacion en Reumatologia y Obesidad
  • Jalisco, Mexico, 44690
    • Centro de Estudios de Investigacion Basica Y Clinica SC
  • Baja California
    • Mexicali, Baja California, Mexico
      • Centro de Investigación en Artritis y Osteoporosis
  • Distrito Federal
    • San Miguel, Distrito Federal, Mexico, 11850
      • Centro de Investigación y Tratamiento Reumatológico S.C
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Morales Vargas Centro de Investigacion SC
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable
    • Zapopan, Jalisco, Mexico, 45030
      • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
  • Yucatán
    • Merida, Yucatán, Mexico, 97000
      • Centro Peninsular de Investigacion S.C.P
• Poland
  • Bydgoszcz, Poland, 85-065
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Lodzkie
    • Łódź, Lodzkie, Poland, 91-365
      • Centrym Medyczne AMED oddzial w Lodzi
  • Lubuskie
    • Nowa Sól, Lubuskie, Poland, 67-100
      • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Malopolskie
    • Krakow, Malopolskie, Poland, 30-510
      • Pratia MCM
    • Kraków, Malopolskie, Poland, 30-363
      • Centrum Medyczne Plejady
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 00-874
      • Medycyna Kliniczna Marzena Waszczak-Jeka
    • Warszawa, Mazowieckie, Poland, 03-291
      • Centrum Medyczne AMED
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 61-545
      • Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Institute of Rheumatology Belgrade
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario A Coruña
• Taiwan
  • Province Of China
    • Taipei, Province Of China, Taiwan, 100
      • National Taiwan University Hospital
• United States
  • California
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials Incorporated
  • Florida
    • Clearwater, Florida, United States, 33765-2616
      • Clinical Research of West Florida Inc - Clearwater
    • Ormond Beach, Florida, United States, 32174
      • Millennium Research
    • Plantation, Florida, United States, 33324
      • IRIS Research and Development LLC
    • Tampa, Florida, United States, 33606-1246
      • Clinical Research of West Florida Inc - Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
  • Kentucky
    • Lexington, Kentucky, United States, 40504-2931
      • Bluegrass Community Research Inc
  • New York
    • Brooklyn, New York, United States, 11201
      • NYU Langone Ambulatory Care Brooklyn Heights
  • North Carolina
    • Charlotte, North Carolina, United States, 28210-8509
      • DJL Clinical Research
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130-3483
      • Paramount Medical Research and Consulting LLC
  • Texas
    • Colleyville, Texas, United States, 76034-5913
      • Precision Comprehensive Clinical Research Solutions
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Mesquite, Texas, United States, 75150
      • Southwest Rheumatology Research, LLC
  • Virginia
    • Danville, Virginia, United States, 24541-1222
      • Spectrum Medical, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daxdilimab; Daxdilimab injections over a total of 48 weeks.	Biological: Daxdilimab; Daxdilimab will be administered subcutaneously as two injections for each dose.; Other Names: HZN-7734

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs).	Day 1 to Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in in plasmacytoid dendritic cells (pDCs).	Day 1 to Week 48
Anti-drug antibody (ADA) rate.	Day 1 to Week 48

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: HZNP-DAX-204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No