Phase 2
N=7
Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
Treatment Efficacy
Bottom Line
View on ClinicalTrials.gov: NCT03345160 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events (AEs) — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut Flour (Drug)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events (AEs) |
7 | — |
| SECONDARY Amount of Peanut Protein Tolerated at the End-of-treatment Peanut Challenge |
4000; 4000; 4000; 4000; 4000; 4000 | — |
Summary
This application is being submitted as a follow-up to Protocol "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children-The IMPACT Study." The IMPACT study was a double-blind, placebo-controlled study of peanut oral immunotherapy in children 12-48 months of age. As part this protocol, all participants who received placebo treatment were promised the opportunity to receive open label treatment at the conclusion of the double-blind phase and initial follow-up. At the time of submitting that protocol, the investigator did not specify any detailed protocol for the open label crossover treatment, as this is an evolving field, but the investigator is now ready to offer this open label treatment as promised.
Eligibility Criteria
Inclusion Criteria
Patients who meet all of the following criteria are eligible for enrollment as study participants, including participants who:
- Subjects who were randomized to the placebo arm of protocol NA\_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children."
- Parent guardian must be able to understand and provide informed consent
- Peanut allergy, as defined by a reaction to a cumulative dose of ≤1000 mg of peanut protein during the End-of-Treatment food challenge from Protocol NA\_00077852 "Oral Immunotherapy for Induction of Tolerance in Peanut Allergic Children"
Exclusion Criteria
Patients who meet any of these criteria are not eligible for enrollment as study participants, including participants who:
- Inability or unwillingness of a parent guardian to give written informed consent or comply with study protocol
- History of severe anaphylaxis to peanut, defined by severe hypoxia, hypotension, neurological compromise, confusion, cardiovascular collapse, or loss of consciousness
- Significant chronic disease (other than asthma, rhinitis, or atopic dermatitis) requiring therapy; e.g., heart disease or cystic fibrosis which is judged by the investigator to have potential impact on study outcomes or safety.
- Severe or poorly controlled atopic dermatitis per investigator's discretion
- Past or current history of eosinophilic gastrointestinal disease
- Diagnosis of asthma that meets any of the following criteria:
- Uncontrolled asthma (as per Global Initiative for Asthma [GINA] latest guidelines)
- History of 2 or more systemic corticosteroid courses or 1 systemic course within the 3 previous months prior to visit 1 for treating wheezing
- Prior intubation/mechanical ventilation for asthma
- Currently receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy.
- Current participation in another clinical trial or participation in another clinical trial in the last 90 days
Data sourced from ClinicalTrials.gov (NCT03345160). 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.