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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 from week 0 to weeks 4, 9, 12, 18, 24, 36 and 48
Awards & highlights
No Placebo-Only Group
Summary
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.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 0 to weeks 4, 9, 12, 18, 24, 36 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 0 to weeks 4, 9, 12, 18, 24, 36 and 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The proportion of participants in the dose escalation phase with at least one Dose Limiting Toxicity (DLT)
Secondary study objectives
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 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613444%
Thrombocytopenia
38%
Peripheral sensory neuropathy
38%
Peripheral Sensory Neuropathy
32%
Anaemia
24%
Fatigue
22%
Diarrhoea
17%
Upper respiratory tract infection
17%
Upper Respiratory Tract Infection
16%
Constipation
15%
Insomnia
15%
Asthenia
13%
Cough
11%
Nausea
11%
Neuralgia
11%
Pyrexia
11%
Dizziness
10%
Back Pain
10%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Headache
6%
Arthralgia
6%
Paraesthesia
6%
Bronchitis
5%
Bone pain
5%
Epistaxis
5%
Bone Pain
5%
Decreased Appetite
5%
Hypocalcaemia
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Alanine aminotransferase increased
4%
Abdominal pain
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Hypertension
3%
Rash
3%
Abdominal Pain Upper
3%
Conjunctivitis
3%
Hypophosphataemia
3%
Abdominal pain upper
3%
Influenza
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Aspartate aminotransferase increased
2%
Muscle spasms
2%
Urinary tract infection
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Herpes Zoster
1%
Pulmonary Embolism
1%
Weight Decreased
1%
Pulmonary embolism
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Orthostatic hypotension
1%
Lower respiratory tract infection
1%
Syncope
1%
Productive cough
1%
Nasal congestion
1%
Respiratory failure
1%
Weight decreased
1%
Chills
1%
Gastroenteritis
1%
Sepsis
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bortezomib + Dexamethasone (Vd)
Daratumumab + Bortezomib and Dexamethasone (DVd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2380
Find a Location
Who is running the clinical trial?
PPD DEVELOPMENT, LPIndustry Sponsor
158 Previous Clinical Trials
36,027 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,716 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,836 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.
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