Peanut Allergy
Conditions
Keywords
Peanut allergy, Abatacept, Oral immunotherapy
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.
Interventions
DRUGAbatacept
24 week treatment of IV abatacept following recommended dosages from the monograph
DRUGPlacebo
24 week treatment of IV placebo following recommended dosages from the abatacept monograph
Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.
Sponsors
Philippe Bégin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peanut specific/total IgE at week 24 | 24 weeks | Relative change in peanut specific/total IgE from baseline to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Peanut-specific IgG4/IgE ratio at week 24 | 24 weeks | Relative change in peanut-specific IgG4/IgE ratio from baseline to week 24 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peanut specific/total IgE, other time points | weeks 2, 6, 12, 36 and 48 | Relative change in peanut specific/total IgE from baseline |
| Peanut-specific IgG4/IgE ratio, other time points | weeks 2, 6, 12, 36 and 48 | Relative change in peanut-specific IgG4/IgE ratio from baseline |
| Peanut-specific IgG4, other time points | weeks 2, 6, 12, 36 and 48 | Absolute change from baseline in peanut-specific IgG4 |
| Skin test | week 12, week 24 and week 48 | Change in peanut skin test from baseline |
| Atopy patch test | week 12, week 24 and week 48 | Change in peanut atopy patch test from baseline |
Countries
Canada
Outcome results
None listed