Status:
COMPLETED
Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy
Lead Sponsor:
Philippe Bégin
Conditions:
Peanut Allergy
Eligibility:
All Genders
14-50 years
Phase:
PHASE2
Brief Summary
This is a phase 2a, multi-center, randomized and double-blind placebo-controlled trial comparing 24 weeks of abatacept versus placebo used as adjuvant to oral immunotherapy to induce remission in adol...
Eligibility Criteria
Inclusion
- Male or female subjects 14 to 50 years old at screening visit
- History of IgE mediated allergy to peanut protein
- ImmunoCAP IgE level \> 50 kU/L for peanut;
- Total IgE level \< 5000 kU/L
- Willing to comply to all study requirements during participation in the study;
Exclusion
- Previous adverse reactions to abatacept;
- Known hypersensitivity to abatacept or any of its components;
- Patients at risk of sepsis, such as immunocompromised or HIV positive;
- Patient undergoing a treatment with any other biologic agent;
- Uncontrolled asthma;
- Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation, administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease);
- Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants or beta-blocker
- Concurrent/prior use of immunomodulatory therapy (within 6 months);
- A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis;
- Pregnant or breastfeeding women;
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04872218
Start Date
March 1 2022
End Date
November 4 2024
Last Update
November 27 2024
Active Locations (1)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T1C5