Adjuvant Treatment With Abatacept to Promote Remission During Peanut Oral Immunotherapy
- Conditions
- Peanut Allergy
- Interventions
- Registration Number
- NCT04872218
- Lead Sponsor
- Philippe Bégin
- 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 adolescents and adults with persistent severe peanut allergy.
This is a proof-of-concept trial in which the primary outcome will be the suppression of the initial peanut specific IgE surge during OIT, which is used as a proxy outcome of peanut allergy remission.
Adolescents and adults with persistent severe peanut allergy (n=14) will be randomized to either abatacept or placebo at a ratio 1:1 for a total period of 24 weeks. Peanut oral immunotherapy will be initiated the day following the first administration of the investigational product. Sustained tolerance to peanut will be assessed at 36 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 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;
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Placebo Peanut oral immunotherapy - Abatacept Peanut oral immunotherapy - Abatacept Abatacept -
- Primary Outcome Measures
Name Time Method Peanut specific/total IgE at week 24 24 weeks Relative change in peanut specific/total IgE from baseline to week 24
- Secondary Outcome Measures
Name Time Method Peanut-specific IgG4/IgE ratio at week 24 24 weeks Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24
Peanut-specific IgG4 at week 24 24 weeks Absolute change in peanut-specific IgG4 from baseline to week 24
Sustained tolerance Assessed between week 36 and week 48 Maximum period of avoidance after which a oral food challenge with 300 mg peanut protein is still tolerated
Food dosing reactions 48 weeks Mean cumulative function of food dosing allergic reactions
Desensitization 36 weeks Highest tolerated dose on an oral food challenge at week 36
Desensitization speed 36 weeks Time from the onset of oral immunotherapy to the maintenance dose of 300mg
Adverse events 48 weeks Overall rate of adverse events
Trial Locations
- Locations (1)
CHU Sainte-Justine
🇨🇦Montréal, Quebec, Canada