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

Amgen

Status and phase: Terminated; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Daxdilimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05430854

HZNP-DAX-204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

Daxdilimab

Experimental group

Description:

Daxdilimab injections over a total of 48 weeks.

Treatment:

Biological: Daxdilimab