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New treatment option for Autoimmune Disorders
Official title Daratumumab in Primary Antiphospholipid Syndrome
ClinicalTrials.gov ID: NCT05671757
What this study is testing
What is Daratumumab?
Daratumumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for autoimmune disorders.
Also referred to as DARZALEX, DARZALEX®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adults 18 to 70 years of age, inclusive.
- The completion of the following vaccinations at least 14 days prior to Visit 0:
- At least one dose of the most recently updated COVID-19 vaccine, and
- At least one dose of the herpes zoster vaccination series, and
- Current seasonal influenza vaccine, if available.
You likely can't join if
- Inability or unwillingness to give written informed consent.
- Inability or unwillingness to comply with study protocol.
- Systemic autoimmune diseases other than APS, including but not limited to:
- Systemic lupus erythematosus (SLE) meeting the EULAR/ACR classification criteria.
- Rheumatoid arthritis meeting the ACR/EULAR classification criteria.
- Small, medium, and large vessel vasculitis meeting ACR classification criteria.
See the full eligibility criteria
Who can join
- Adults 18 to 70 years of age, inclusive.
- The completion of the following vaccinations at least 14 days prior to Visit 0:
- At least one dose of the most recently updated COVID-19 vaccine, and
- At least one dose of the herpes zoster vaccination series, and
- Current seasonal influenza vaccine, if available.
- 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...
- History of triple positive aPL within the prior 5 years and at least 12 weeks prior to enrollment, including all of the following:
- aCL IgG level \> Upper Limit of Normal (ULN), and
- aβ2GPI IgG level \> ULN, and
- Positive LA test.
- Confirmation of triple positive aPL at screening, including all of the following:
- aCL IgG level ≥ 40 GPL, and
- aβ2GPI IgG level ≥ 40 SGU, and
- Positive LA test.
- Undergoing anticoagulation with warfarin or low molecular weight heparin (LMWH), if there is a history of arterial or venous thrombosis.
What rules you out
- Inability or unwillingness to give written informed consent.
- Inability or unwillingness to comply with study protocol.
- Systemic autoimmune diseases other than APS, including but not limited to:
- Systemic lupus erythematosus (SLE) meeting the EULAR/ACR classification criteria.
- Rheumatoid arthritis meeting the ACR/EULAR classification criteria.
- Small, medium, and large vessel vasculitis meeting ACR classification criteria.
- Catastrophic APS classification within the prior 90 days.
- Acute arterial or venous thrombosis within the prior 30 days.
- Use of the following medications:
- Any prior treatment with CD38 targeting monoclonal antibodies, including daratumumab or isatuximab-irfc.
- The following within the prior 30 days: i. Corticosteroids \> 10 mg/day prednisone or equivalent. ii. Direct oral anticoagulants (DOACs). iii. Live attenuated vaccines. iv. IVIG or other supplemental immunoglobulin. c...
- Plasma exchange within the prior 90 days.
- Hemodialysis within the prior 90 days.
- Major surgical procedure within the prior 60 days.
- Known allergy, hypersensitivity, or intolerance to boron, malitol, sorbitol, corticosteroids, monoclonal antibodies including daratumumab, human proteins, or their excipients.
- Allergy, intolerance, or contraindication to acyclovir, valacyclovir, and famciclovir.
- Active or chronic infection, including the following:
- Active bacterial, viral, fungal, or opportunistic infection.
- Chronic infection requiring suppressive antibiotic treatment.
- Intravenous antibiotics or hospitalization for infection within the prior 30 days.
- Evidence of current or prior Mycobacterium tuberculosis infection.
- Human immunodeficiency virus (HIV).
- Current or prior infection with hepatitis B virus (HBV).
- Current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response ≥ 12 weeks.
- History of recurrent herpes zoster, or history of herpes zoster ophthalmicus, disseminated herpes zoster, or disseminated herpes simplex.
- The following laboratory abnormalities: ITN093AI: DARE-APS Version 3.0 September 12, 2023 Daratumumab in Primary Antiphospholipid Syndrome
- Absolute neutrophil count \< 1500/mm3.
- Platelets \< 100,000/mm3.
- Hemoglobin (Hgb) \< 10 g/dL.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase \> 2x the Upper Limit of Normal (ULN).
- Total bilirubin \> 2x ULN, except in the case of congenital bilirubinemia then direct bilirubin \> 2x ULN.
- eGFR \< 45 ml/min/1.73 m2.
- History of primary immunodeficiency.
- History of solid organ or hematopoietic stem cell transplantation.
- Comorbidities requiring systemic corticosteroid therapy, including those which have required three or more courses of systemic corticosteroids within the 12 months prior to Visit 0.
- Any of the following conditions with FEV1 \< 70% predicted within the prior 90 days:
- Asthma.
- Chronic obstructive pulmonary disease (COPD).
- DAH.
- Pulmonary hypertension.
- Adrenal insufficiency.
- Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥ 8.0%.
- Concomitant malignancy or history of malignancy, except adequately treated or excised nonmetastatic squamous cell carcinoma, basal cell skin carcinoma, or cervical carcinoma in situ.
- Clinically significant cardiac disease, including but not limited to:
- Myocardial infarction within the prior 6 months, or
- Unstable or uncontrolled disease or condition related to or affecting cardiac function, including but not limited to: i. Unstable angina, or ii. Congestive heart failure, New York Heart Association Class II-IV, or iii...
- Current diagnosed mental illness or current diagnosed or self-reported drug or alcohol abuse which, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
- Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease.
- Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the...
- Lack of peripheral venous access.
- Pregnancy, or planning a pregnancy during the 48 week study duration.
- Breast-feeding.
- Unwillingness to use medically acceptable non-prothrombotic contraception if of reproductive potential and engaging in sexual activity that could lead to pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Great Neck, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States; Great Neck, New York, United States; New York, New York, United States; Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.