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

Stopped early · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT05430854

Run by

Amgen

People needed

155

Starts

2022-06-01

Expected to finish

2023-10-31

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Inland Rheumatology Clinical Trials Incorporated — Upland, California, United States

Full record on ClinicalTrials.gov

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