Status:
TERMINATED
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
Lead Sponsor:
Amgen
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
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 SL...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT05430854
Start Date
June 1 2022
End Date
October 31 2023
Last Update
September 19 2024
Active Locations (52)
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1
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States, 91786
2
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States, 33765-2616
3
Millennium Research
Ormond Beach, Florida, United States, 32174
4
IRIS Research and Development LLC
Plantation, Florida, United States, 33324