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Terminated/Withdrawn
Sponsor ID
HZNP-DAX-204

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

Sponsor ID
HZNP-DAX-204
Clinicaltrials.gov ID
NCT05430854
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
155
Additional Study Details

Protocol Summary

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).

Timeframe: Day 1 to Week 48

Secondary Outcome Measures

Change from baseline in in plasmacytoid dendritic cells (pDCs).

Timeframe: Day 1 to Week 48

Anti-drug antibody (ADA) rate.

Timeframe: Day 1 to Week 48

Locations

Location
Status
Contact Us
Location
Inland Rheumatology Clinical Trials Incorporated
Upland, California, United States, 91786
Status
Active, not recruiting
Location
Clinical Research of West Florida Inc - Clearwater
Clearwater, Florida, United States, 33765-2616
Status
Active, not recruiting
Location
Millennium Research
Ormond Beach, Florida, United States, 32174
Status
Active, not recruiting
Location
IRIS Research and Development LLC
Plantation, Florida, United States, 33324
Status
Active, not recruiting
Location
Clinical Research of West Florida Inc - Tampa
Tampa, Florida, United States, 33606-1246
Status
Active, not recruiting
Location
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Status
Active, not recruiting
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Study Info
Age
18 - 72 Years
Condition
  • Lupus
    • Sex
    All
    Trial Dates
    Jun 2022 - Oct 2023
    Inclusion and Exclusion 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.