Phase 2
Completed N=146
Peanut Oral Immunotherapy in Children
Peanut Hypersensitivity
Source: ClinicalTrials.gov NCT01867671 ↗
Enrolled (actual)
146
Serious AEs
4.8%
Results posted
Jan 2020
Primary outcomePrimary: Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT) — 71; 2 Percentage of Participants — p=<0.0001
Summary
This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT) |
71; 2 | <0.0001 sig |
| SECONDARY Percentage of Tolerant Participants at Week 160 |
21; 2 | <0.0031 sig |
| SECONDARY Count of Participants With Transient Desensitization |
49; 19; 27; 1 | <0.0001 sig |
| SECONDARY Highest Tolerated Cumulative Dose |
1645; 180 | <0.0001 sig |
| SECONDARY Percentage of Participants That Withdrew From the Study |
2; 0; 4; 12; 8; 16 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
- Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
- Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
- A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
- Written informed consent from parent/guardian.
Exclusion Criteria
- History of severe anaphylaxis with hypotension to peanut;
- Documented clinical history of allergy to oat;
- Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
- Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
- Active eosinophilic gastrointestinal disease in the past 2 years;
- Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
- Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
- Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
- Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
- Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
- Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
- Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
- Use of any investigational drug in 90 days prior to visit -1;
- Plan to use any investigational drug during the study period;
- The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Data sourced from ClinicalTrials.gov (NCT01867671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.