NCT05671757 · National Institute of Allergy and Infectious Diseases (NIAID)
Daratumumab in Primary Antiphospholipid Syndrome
(DARE-APS)
What this study is about
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 group of participants with the potential to enroll an additional 4 subjects in the highest safe dose (HSD) group of participants, for a total of up to 22 participants.
View original scientific description
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.
Interventions
BIOLOGICAL
Daratumumab
Participants will receive 4 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
BIOLOGICAL
Daratumumab
Participants will receive 4-8 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
BIOLOGICAL
Daratumumab
Participants will receive 4-16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48
Primary outcome measures
The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT)
Time frame: At or before week 9
Proportions will be estimated by dose cohort with 95% confidence intervals derived using the Clopper-Pearson exact method
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults 18 to 70 years of age, inclusive. 2. The completion of the following vaccinations at least 14 days prior to Visit 0: 1. At least one dose of the most recently updated COVID-19 vaccine, and 2. At least one dose of the herpes zoster vaccination series, and 3. Current seasonal influenza vaccine, if available. 3. History of APS according to the updated 2006 Sapporo classification criteria, including at least one of the following: a. Arterial thrombosis, except transient ischemic attack, confirmed by objective validated criteria such as imaging, or b. Venous thrombosis, except superficial thrombophlebitis, confirmed by objective validated criteria such as imaging, or c. Pregnancy morbidity, based on the updated 2006 Sapporo APS classification criteria, or d. Microvascular APS, with at least one of the following: i. Renal biopsy documentation of aPL-associated nephropathy, or ii. Lung biopsy or bronchoalveolar lavage documentation of diffuse alveo
Where
- Baltimore, Maryland
- Ann Arbor, Michigan
- Rochester, Minnesota
- Great Neck, New York
- New York, New York
- Durham, North Carolina
Collaborators
Immune Tolerance Network (ITN), PPD Development, LP, Rho Federal Systems Division, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations