Peanut allergy can cause serious and potentially life-threatening allergic reactions. Oral immunotherapy (OIT) is an investigational treatment that involves giving small, gradually increasing amounts of peanut protein to help reduce allergic sensitivity. However, OIT may cause allergic reactions during treatment.
This Phase II clinical trial will compare two forms of peanut used for oral immunotherapy: standard blanched peanuts and autoclaved peanuts (peanuts heated under high temperature and pressure to modify their proteins). Participants aged 4 to 30 years with confirmed peanut allergy will be randomly assigned to receive one of the two treatments.
The study will evaluate safety, tolerability, adherence, and the ability to tolerate a higher amount of peanut protein after 12 months of therapy. The goal is to determine whether autoclaved peanuts provide a safer and better tolerated approach to peanut oral immunotherapy.
A history suggestive of immediate IgE-mediated peanut allergy (more than 2 mild symptoms or more than 1 moderate or severe symptom within 120 minutes of ingestion or contact).
Positive SPT to peanut (wheal equal of more than 3 mm above saline control).
Serum specific IgE equal or more than 0.35 kU/L to peanut or peanut components.
Previous positive oral food challenge to peanut (raw, roasted or blanched) according to EAACI guidelines.
• Unstable asthma or uncontrolled chronic respiratory disease.
Active infectious or inflammatory conditions.
Non-IgE-mediated or non-immunological adverse reactions to peanuts.
Patients receiving immunosuppressor therapy.
Parallel
Autoclaved peanut oral immunotherapy
Other interventionAutoclaved peanut protein administered orally in gradually increasing doses during escalation phase up to 300 mg, followed by daily 300 mg maintenance dosing for 12 months.
Blanched peanut oral immunotherapy
Other interventionStandard blanched peanut protein administered orally in gradually increasing doses during escalation phase up to 300 mg, followed by daily 300 mg maintenance dosing for 12 months.
Proportion of Participants Tolerating 2043 mg Peanut Protein at Exit Double-Blind Placebo-Controlled Food Challenge
The primary outcome is the proportion of participants in each group who can tolerate a cumulative dose of 2043 mg of peanut protein (equivalent to 8172 mg crushed peanut or 8 peanuts) during the exit challenge at approximately 12 months
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This trial is not recruiting at the moment. You can still explore other options:
