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

Primary Purpose

Systemic Lupus Erythematosus

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daxdilimab
Sponsored by
Horizon Therapeutics Ireland DAC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inland Rheumatology Clinical Trials Incorporated
  • Clinical Research of West Florida Inc - Clearwater
  • Millennium Research
  • IRIS Research and Development LLC
  • Clinical Research of West Florida Inc - Tampa
  • Emory University School of Medicine
  • Bluegrass Community Research Inc
  • NYU Langone Ambulatory Care Brooklyn Heights
  • DJL Clinical Research
  • Paramount Medical Research and Consulting LLC
  • Precision Comprehensive Clinical Research Solutions
  • Metroplex Clinical Research Center
  • Southwest Rheumatology Research, LLC
  • Spectrum Medical, Inc
  • Consultorios Médicos Dr. Doreski
  • Clínica Adventista Belgrano
  • Framingham Centro Médico
  • Instituto CER S.A
  • Instituto de Investigaciones Clinicas Quilmes SRL
  • Centro Medico Privado de Reumatologia
  • Consultorio de Investigaciones Reumatologicas
  • Athens General Hospital 'G Gennimatas
  • Laiko General Hospital of Athens
  • University General Hospital of Larissa
  • Kianous Stavros
  • Krishna Institute of Medical Sciences
  • AES - AS - Panchshil Hospital - Ahmedabad
  • AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat
  • AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli
  • Jasleen Hospital
  • Centro de Investigación en Artritis y Osteoporosis
  • Centro de Investigación y Tratamiento Reumatológico S.C
  • Morales Vargas Centro de Investigacion SC
  • Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
  • Centro Peninsular de Investigacion S.C.P
  • Consultorio de Reumatologia
  • Clinica de Investigacion en Reumatologia y Obesidad
  • Centro de Estudios de Investigacion Basica Y Clinica SC
  • Centrym Medyczne AMED oddzial w Lodzi
  • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Pratia MCM
  • Centrum Medyczne Plejady
  • Medycyna Kliniczna Marzena Waszczak-Jeka
  • Centrum Medyczne AMED
  • Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Institute of Rheumatology Belgrade
  • Military Medical Academy
  • University Clinical Center Kragujevac
  • Hospital Universitario A Coruña
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daxdilimab

Arm Description

Daxdilimab injections over a total of 48 weeks.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs).

Secondary Outcome Measures

Change from baseline in in plasmacytoid dendritic cells (pDCs).
Anti-drug antibody (ADA) rate.

Full Information

First Posted
June 20, 2022
Last Updated
October 13, 2023
Sponsor
Horizon Therapeutics Ireland DAC
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1. Study Identification

Unique Protocol Identification Number
NCT05430854
Brief Title
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
Acronym
RECAST SLE OLE
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horizon Therapeutics Ireland DAC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daxdilimab
Arm Type
Experimental
Arm Description
Daxdilimab injections over a total of 48 weeks.
Intervention Type
Biological
Intervention Name(s)
Daxdilimab
Other Intervention Name(s)
HZN-7734
Intervention Description
Daxdilimab will be administered subcutaneously as two injections for each dose.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and treatment-emergent adverse events of special interest (AESIs).
Time Frame
Day 1 to Week 48
Secondary Outcome Measure Information:
Title
Change from baseline in in plasmacytoid dendritic cells (pDCs).
Time Frame
Day 1 to Week 48
Title
Anti-drug antibody (ADA) rate.
Time Frame
Day 1 to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nisha Jain, MD
Organizational Affiliation
Horizon Therapeutics Ireland DAC
Official's Role
Study Director
Facility Information:
Facility Name
Inland Rheumatology Clinical Trials Incorporated
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Clinical Research of West Florida Inc - Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765-2616
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
IRIS Research and Development LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Clinical Research of West Florida Inc - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-1246
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Bluegrass Community Research Inc
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504-2931
Country
United States
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8509
Country
United States
Facility Name
Paramount Medical Research and Consulting LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130-3483
Country
United States
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034-5913
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Southwest Rheumatology Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Spectrum Medical, Inc
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541-1222
Country
United States
Facility Name
Consultorios Médicos Dr. Doreski
City
Ciudad Autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Clínica Adventista Belgrano
City
Estomba
State/Province
Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Framingham Centro Médico
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1902COS
Country
Argentina
Facility Name
Instituto CER S.A
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Quilmes SRL
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Centro Medico Privado de Reumatologia
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Consultorio de Investigaciones Reumatologicas
City
San Miguel De Tucumán
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Athens General Hospital 'G Gennimatas
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Laiko General Hospital of Athens
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larisa
ZIP/Postal Code
411 10
Country
Greece
Facility Name
Kianous Stavros
City
Thessaloníki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Krishna Institute of Medical Sciences
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
Facility Name
AES - AS - Panchshil Hospital - Ahmedabad
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380005
Country
India
Facility Name
AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat
City
Sūrat
State/Province
Gujarat
ZIP/Postal Code
395010
Country
India
Facility Name
AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580021
Country
India
Facility Name
Jasleen Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Centro de Investigación en Artritis y Osteoporosis
City
Mexicali
State/Province
Baja California
Country
Mexico
Facility Name
Centro de Investigación y Tratamiento Reumatológico S.C
City
San Miguel
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion SC
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Centro Peninsular de Investigacion S.C.P
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Consultorio de Reumatologia
City
Ciudad de Mexico
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad
City
Guadalajara
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Centro de Estudios de Investigacion Basica Y Clinica SC
City
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Facility Name
Centrym Medyczne AMED oddzial w Lodzi
City
Łódź
State/Province
Lodzkie
ZIP/Postal Code
91-365
Country
Poland
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sól
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Pratia MCM
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Medycyna Kliniczna Marzena Waszczak-Jeka
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-874
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Institute of Rheumatology Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
University Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Hospital Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Province Of China
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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