Phase 2
N=15
Salvage Peanut Oral Immunotherapy Study
Peanut Allergy
Bottom Line
View on ClinicalTrials.gov: NCT03251508 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcome: Primary: Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety) — 60 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut OIT (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment-emergent Adverse Events During the 2-stage Study Sequence (Safety) |
60 | — |
| SECONDARY Percentage of Missed Doses During the 2-stage Study Sequence (Compliance) |
1.2 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-emergent Adverse Events During the Peanut Oral Immunotherapy Stage |
60 | — |
| SECONDARY Percentage of Missed Doses During the Peanut Oral Immunotherapy Stage |
2.1 | — |
| SECONDARY Percentage of Participants Utilizing Emergency Epinephrine Use During the 2-Stage Study Sequence (Safety) |
— | — |
| SECONDARY Percentage of Participants Experiencing Gastrointestinal Adverse Events During the 2-stage Study Sequence (Safety) |
53.33 | — |
| SECONDARY Percentage of Participants Withdrawing During the 2-stage Study Sequence Due to Gastrointestinal Adverse Events (Safety) |
13.33 | — |
Summary
The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization during a peanut immunotherapy trial.
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut.
- Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from patient or parent/guardian (if < 18 years) with participant's assent.
Exclusion Criteria
- Current participation in an interventional study for peanut allergy
- History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
- Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
- Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2)
- Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions.
Pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT03251508). 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.