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

Systemic Lupus Erythematosus Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05430854
• Other study ID #: HZNP-DAX-204
• Status: Terminated
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• Daxdilimab
Daxdilimab will be administered subcutaneously as two injections for each dose.

Locations

Country	Name	City	State
Argentina	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
Argentina	Consultorio de Investigaciones Reumatologicas	San Miguel De Tucumán	Tucumán
Greece	Athens General Hospital 'G Gennimatas	Athens
Greece	Laiko General Hospital of Athens	Athens
Greece	University General Hospital of Larissa	Larisa
Greece	Kianous Stavros	Thessaloníki
India	AES - AS - Panchshil Hospital - Ahmedabad	Ahmedabad	Gujarat
India	AES - AS - Sushruta Multispeciality Hospital & Research Center Pvt Ltd - Hubli	Hubli	Karnataka
India	Jasleen Hospital	Nagpur	Maharashtra
India	Krishna Institute of Medical Sciences	Secunderabad	Andhra Pradesh
India	AES - AS - Unity Trauma Center and ICU - Unity Hospital - Surat	Surat	Gujarat
Mexico	Consultorio de Reumatologia	Ciudad de Mexico
Mexico	Bioclinica - Centro Integral En Reumatologia Sociedad Anónima de Capital Variable	Guadalajara	Jalisco
Mexico	Clinica de Investigacion en Reumatologia y Obesidad	Guadalajara
Mexico	Centro de Estudios de Investigacion Basica Y Clinica SC	Jalisco
Mexico	Morales Vargas Centro de Investigacion SC	León	Guanajuato
Mexico	Centro Peninsular de Investigacion S.C.P	Merida	Yucatán
Mexico	Centro de Investigación en Artritis y Osteoporosis	Mexicali	Baja California
Mexico	Centro de Investigación y Tratamiento Reumatológico S.C	San Miguel	Distrito Federal
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan	Jalisco
Poland	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz
Poland	Pratia MCM	Krakow	Malopolskie
Poland	Centrum Medyczne Plejady	Kraków	Malopolskie
Poland	Centrym Medyczne AMED oddzial w Lodzi	Lódz	Lodzkie
Poland	Twoja Przychodnia - Centrum Medyczne Nowa Sol	Nowa Sól	Lubuskie
Poland	Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi	Poznan	Wielkopolskie
Poland	Centrum Medyczne AMED	Warszawa	Mazowieckie
Poland	Medycyna Kliniczna Marzena Waszczak-Jeka	Warszawa	Mazowieckie
Serbia	Institute of Rheumatology Belgrade	Belgrade
Serbia	Military Medical Academy	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac
Spain	Hospital Universitario A Coruña	A Coruña
Taiwan	National Taiwan University Hospital	Taipei	Province Of China
United States	Emory University School of Medicine	Atlanta	Georgia
United States	NYU Langone Ambulatory Care Brooklyn Heights	Brooklyn	New York
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Clinical Research of West Florida Inc - Clearwater	Clearwater	Florida
United States	Precision Comprehensive Clinical Research Solutions	Colleyville	Texas
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Spectrum Medical, Inc	Danville	Virginia
United States	Bluegrass Community Research Inc	Lexington	Kentucky
United States	Southwest Rheumatology Research, LLC	Mesquite	Texas
United States	Paramount Medical Research and Consulting LLC	Middleburg Heights	Ohio
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	Inland Rheumatology Clinical Trials Incorporated	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Greece,  India,  Mexico,  Poland,  Serbia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in in plasmacytoid dendritic cells (pDCs).		Day 1 to Week 48
Secondary	Anti-drug antibody (ADA) rate.		Day 1 to Week 48