Phase 2
N=56
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT
Peanut Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01987817 ↗Enrolled (actual)
56
Serious AEs
3.6%
Results posted
Nov 2021
Primary outcome: Primary: The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC — 23; 5 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AR101 powder provided in capsules (Biological); Placebo powder provided in capsules (Biological)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Aimmune Therapeutics, Inc.
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Who Tolerate at Least 300 mg (443 mg Cumulative) of Peanut Protein With no More Than Mild Symptoms at the Exit DBPCFC |
23; 5 | <0.0001 sig |
| SECONDARY Change From Baseline in Maximum Tolerated Dose of Peanut Protein at the Exit DBPCFC |
1.254; 0.341 | <0.0001 sig |
| SECONDARY Number of Participants by Maximum Dose Achieved With no or Mild Symptoms at Exit DBPCFC |
0; 1; 2; 2; 3; 7 | — |
| SECONDARY Changes in Peanut-Specific IgE From Baseline to Exit DBPCFC |
32.571; 53.839; 36.889; 57.060; 1.231; 1.060 | — |
| SECONDARY Changes in Peanut-Specific IgG4 From Baseline to Exit DBPCFC |
0.734; 0.510; 3.609; 0.540; 5.068; 1.066 | — |
| SECONDARY Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter Results From Baseline |
14.1; 13.7; 7.1; 11.8; -7.0; -1.8 | — |
Summary
This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.
Eligibility Criteria
Key Inclusion Criteria
- Ages 4 through 26 years, inclusive
- Clinical history of allergy to peanuts or peanut-containing foods
- Serum IgE to peanut >0.35 kU/L (determined by UniCAP within the past 12 months) and/or a SPT to peanut >3 mm compared to control
- Experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via PRACTALL guidelines
- Use of birth control by females of child-bearing potential
Key Exclusion Criteria
- History of Cardiovascular disease
- History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
- History of other chronic disease
- History of eosinophilic gastrointestinal disease
- Severe asthma
- Mild or moderate asthma if uncontrolled
- Use of omalizumab within the past 6 months or current use of other non-traditional forms of allergen immunotherapy
- Use of beta-blockers(oral), angiotensin-converting enzyme (ACE)
- Pregnancy, lactation
- Having the same place of residence as another study subject
- Participation in an interventional clinical trial 30 days prior to randomization
Data sourced from ClinicalTrials.gov (NCT01987817). 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.