Phase 2
N=146
Peanut Oral Immunotherapy in Children
Peanut Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01867671 ↗Enrolled (actual)
146
Serious AEs
4.8%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT) — 71; 2 Percentage of Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut Oral Immunotherapy - Liquid Extract (Biological); Placebo for Peanut Oral Immunotherapy - Liquid Extract form (Biological); Peanut Oral Immunotherapy - Peanut Flour (Biological); Placebo for Peanut Oral Immunotherapy - Peanut Flour (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jul 2018
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 | — |
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.
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.