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Monoclonal Antibodies
Daratumumab for Antiphospholipid Syndrome (DARE-APS Trial)
Phase 1 & 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at weeks 4, 9, 12, 18, 24, 36 and 48
Awards & highlights
DARE-APS Trial Summary
This trial is testing a med to see if it's safe to treat people with Anti-Phospholipid Syndrome (APS). Up to 22 people will get 8 doses of the med at 4, 8, or 16 mg/kg. The goal is to see if it causes any side effects.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the safety of daratumumab at different doses (4 mg/kg, 8 mg/kg, and 16 mg/kg) in treating APS. Up to 22 participants will receive intravenous doses on a set schedule to identify any dose-limiting toxicities during this phase.See study design
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased risk of infections or bleeding, possible liver function alterations indicated by enzyme levels, and allergic responses due to sensitivity towards daratumumab's components.
DARE-APS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at weeks 4, 9, 12, 18, 24, 36 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at weeks 4, 9, 12, 18, 24, 36 and 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT)
Secondary outcome measures
Change in Anti-beta2-glycoprotein test Immunoglobulin G (abeta2GPI IgG) levels
Change in Anticardiolipin antibodies Immunoglobulin M (aCL IgM) levels
The proportion of Grade 2 or higher adverse event (AEs) related to daratumumab
+8 moreOther outcome measures
MECHANISTIC: Global changes in gene expression of molecules
MECHANISTIC: Immunophenotypin
MECHANISTIC: Level of circulating cell
+6 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Nasal congestion
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Gastroenteritis
1%
Femur fracture
1%
Pleural effusion
1%
Pathological fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
DARE-APS Trial Design
3Treatment groups
Experimental Treatment
Group I: 8 mg/kg CohortExperimental Treatment1 Intervention
This cohort will receive intravenous (IV) administration of 8 mg/kg 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
Group II: 4 mg/kg CohortExperimental Treatment1 Intervention
This cohort will receive intravenous (IV) administration of 4 mg/kg 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
Group III: 16 mg/kg CohortExperimental Treatment1 Intervention
This cohort will receive intravenous (IV) administration of 16 mg/kg 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,447 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,896 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,893 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing infection.My condition is getting worse and not under control.I am on long-term steroids for other health issues.I am between 18 and 70 years old.I have not taken certain medications recently.I have had an organ or stem cell transplant.I am not willing to use birth control.I am willing to take blood thinners if I have a history of blood clots.I have not had major surgery in the last 60 days.My blood test shows I have triple positive antiphospholipid antibodies.I have not had a plasma exchange in the last 3 months.I have a serious heart condition.I don't have health issues that could affect my participation in the study.I have an autoimmune disease, but it's not APS.I have not had a blood clot in the last 30 days.I have been on hemodialysis in the last 3 months.I am allergic or cannot take certain antiviral medications.I completed all required vaccinations at least 14 days ago.My lung function test shows less than 70% of the expected value.
Research Study Groups:
This trial has the following groups:- Group 1: 4 mg/kg Cohort
- Group 2: 8 mg/kg Cohort
- Group 3: 16 mg/kg Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper age limit for participants in this research trial?
"Entrants of this trial must fall between the ages 18 and 65. There are 16 trials for minors, while those over 65 may choose from 41 different studies."
Answered by AI
Are interested participants able to join this investigation presently?
"Clinicaltrials.gov confirms that this medical trial is not presently recruiting new participants, despite being initially posted on March 12th 2023 and having its last update on April 1st of the same year. However, there are 58 other trials actively searching for volunteers at present."
Answered by AI
Are there any specific qualifications necessary to participate in this trial?
"This clinical trial is seeking 22 adults aged 18-65 with autoimmune diseases. To be eligible, applicants must have a positive lupus anticoagulant (LA) test, the willingness and ability to receive warfarin or low molecular weight heparin (LMWH), possess current CDC & ACIP recommended COVID-19 vaccinations, completed their herpes zoster series shots if applicable, obtained their seasonal influenza vaccine if available, meet Sapporo classification criteria for APS within 5 years prior to enrollment including arterial/venous thrombosis or pregnancy morbidity/microvascular APS documentation from renal biopsy/"
Answered by AI
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