Daratumumab for Antiphospholipid Syndrome
(DARE-APS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if daratumumab, an IV medication, is safe for people with Anti-Phospholipid Syndrome (APS). APS patients are being studied because they may not respond well to usual treatments. Daratumumab works by helping the immune system target specific cells that might be causing issues.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. Specifically, you must not have used corticosteroids over 10 mg/day, direct oral anticoagulants, certain immunosuppressive drugs, or biologic agents within specified time frames before joining the study. If you are on warfarin or low molecular weight heparin due to a history of thrombosis, you may continue these medications.
Is Daratumumab generally safe for humans?
The safety of biological therapies, like Daratumumab, has been studied in various conditions, primarily in rheumatic diseases. These studies often focus on the risk of severe adverse events (serious side effects) within a few months of treatment. While specific data on Daratumumab for Antiphospholipid Syndrome is not available, safety registers for similar treatments help monitor and report any safety concerns.12345
How is the drug Daratumumab different from other treatments for antiphospholipid syndrome?
Daratumumab is unique because it is an immunotherapy drug that targets specific proteins on immune cells, unlike traditional treatments for antiphospholipid syndrome which primarily focus on anticoagulation to prevent blood clots. This approach may offer a novel way to address the underlying immune system dysfunction in this condition.678910
What data supports the effectiveness of the drug Daratumumab for treating Antiphospholipid Syndrome?
Daratumumab has shown effectiveness in treating multiple myeloma, a type of blood cancer, by inducing strong and lasting responses in patients. It has also been used successfully in treating immune thrombocytopenia (a condition where the immune system attacks platelets) by targeting cells that produce harmful antibodies, suggesting potential benefits for other immune-related conditions.1112131415
Who Is on the Research Team?
Doruk Erkan, M.D., M.P.H.
Principal Investigator
Hospital for Special Surgery, New York: Division of Rheumatology
Jason Knight, M.D., Ph.D.
Principal Investigator
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with Anti-Phospholipid Syndrome (APS), who meet specific criteria including a history of certain types of thrombosis or pregnancy complications related to APS. Participants must have completed recommended vaccinations, be willing to use warfarin or LMWH for anticoagulation, and not have other autoimmune disorders like rheumatoid arthritis or systemic lupus erythematosus.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive weekly intravenous administration of daratumumab for 8 doses to determine the highest safe dose
Expansion Phase
Four additional participants are treated at the highest safe dose weekly for 8 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Daratumumab is already approved in European Union, United States for the following indications:
- Relapsed and refractory multiple myeloma
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Multiple myeloma in patients who have received at least three prior therapies
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD Development, LP
Industry Sponsor
Immune Tolerance Network (ITN)
Collaborator
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelorโs degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
Rho Federal Systems Division, Inc.
Industry Sponsor