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Daratumumab in Primary Antiphospholipid Syndrome

Study acronym: DARE-APS
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jun 24, 2026 → Oct 16, 2026
See other at-risk trials from National Institute of Allergy and Infectious Diseases (NIAID)

Record History

  1. Primary completion pushed from Jun 24, 2026 to Oct 16, 2026 Eligibility criteria expanded, about 46 words · Secondary endpoints: details revised at 3 of 15 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: details revised at 3 of 15 entries
  2. Site details revised at 1 of 8 sitesv17
  3. Eligibility criteria shortened, about 11 words Secondary endpoints revised (15)v16 Show 1 more changeShow less
    • Secondary endpoints revised (15)

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Oct 29, 2025 to Jun 24, 2026 Completion date: Oct 29, 2025 to Mar 2027v15 Show 1 more changeShow less
    • Completion date: Oct 29, 2025 to Mar 2027
  5. Eligibility criteria shortened, about 44 wordsv14 See this version in full on ClinicalTrials.gov ↗
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 1 of 8 sitesv13
  2. Primary and study completion dates: Apr 29, 2024 to Oct 29, 2025v12
  3. Site details revised at 1 of 8 sitesv11
  4. Site details revised at 1 of 8 sitesv10
  5. Start date: Jul 6, 2023 to May 26, 2023v9
  6. Site details revised at 1 of 8 sitesv8
  7. Site details revised at 1 of 8 sitesv7
  8. Eligibility criteria shortened, about 18 wordsv6 See this version in full on ClinicalTrials.gov ↗
  9. Start date changed from estimate of Jul 7, 2023 to Jul 6, 2023 Site details revised at 1 of 8 sitesv5 Show 1 more changeShow less
    • Site details revised at 1 of 8 sites
  10. Start date: May 23, 2023 to Jul 7, 2023v4
  11. Site details revised at 1 of 8 sitesv3
  12. Trial status: Not Yet Recruiting to Recruiting Start date: Mar 12, 2023 to May 23, 2023 · Site details revised at 8 of 8 sitesv2 Show 2 more changesShow less
    • Start date: Mar 12, 2023 to May 23, 2023
    • Site details revised at 8 of 8 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to see if the study medication, daratumumab, is safe to treat individuals with Anti-Phospholipid Syndrome (APS). Three daratumumab dosing cohorts are planned with up to six participants in each dosing cohort with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) cohort, for a total of up to 22 participants. The dosing cohorts are: 4 mg/kg, 8 mg/kg, and 16 mg/kg. Each cohort will receive intravenous (IV) administration of daratumumab according to the following schedule, for a total of 8 doses. The primary objective is to determine the safety of daratumumab in APS defined as Dose Limiting Toxicities (DLTs) occurring during the dose escalation phase.
Trial Details
NCT Number NCT05671757
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
Conditions Autoimmune Disorders
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov