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NCT05671757 · ClinicalTrials.gov registry record · Phase 1
Daratumumab in Primary Antiphospholipid Syndrome
A Phase 1 study of Autoimmune Disorders, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 8
- Study locations
NCT05671757: Recruiting Phase 1 study of Autoimmune Disorders, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT05671757 is a Phase 1 study of Autoimmune Disorders that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 22 participants, below the 526-participant average among 3 other Autoimmune Disorders trials with a reported enrollment target (96% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05671757, a Phase 1 study of Autoimmune Disorders, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
Proportions will be estimated by dose cohort with 95% confidence intervals derived using the Clopper-Pearson exact method
Conditions Studied
Interventions
- BIOLOGICAL Daratumumab
Study Locations (8)
New York
- Northwell Health - Great Neck
- NYU Langone - New York
- Hospital for Special Surgery - New York
- Weill Cornell - New York
Maryland
- Johns Hopkins University - Baltimore
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic Rochester - Rochester
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2023-05-26 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What NCT05671757 shows while recruiting
NCT05671757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 526-participant average among 3 other Autoimmune Disorders trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Autoimmune Disorders appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab is the first listed.
NCT05671757 lists 8 locations in 5 states (New York, Maryland, Michigan).
Frequently Asked Questions
What is clinical trial NCT05671757 about?
NCT05671757 is a clinical study titled "Daratumumab in Primary Antiphospholipid Syndrome". 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 h...
What is the current status of trial NCT05671757?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2023-05-26. Estimated completion is 2027-03.
What conditions does trial NCT05671757 study?
This clinical trial studies the following conditions: Autoimmune Disorders.
What interventions are being tested in trial NCT05671757?
The interventions under investigation include: Daratumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05671757?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05671757 being conducted?
This trial has 8 study locations across Maryland, Michigan, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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