Phase 2
N=54
Sublingual Immunotherapy for Peanut Allergy and Induction of Tolerance
Peanut Hypersensitivity · Food Hypersensitivity · Food Allergy · Peanut Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01373242 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Population Sensitization Threshold in mg Peanut Protein Predicted to Provoke Reactions in 5% of the Peanut-allergic Population — 160; 300 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liquid peanut extract (Peanut SLIT) (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Population Sensitization Threshold in mg Peanut Protein Predicted to Provoke Reactions in 5% of the Peanut-allergic Population |
160; 300 | — |
| PRIMARY Population Sensitization Threshold in mg Peanut Protein Predicted to Provoke Reactions in 10% of the Peanut-allergic Population |
800; 750 | — |
| PRIMARY Population Estimate of Time for a Subject's True Sensitivity Threshold to Reduce by Half. |
17 | — |
| PRIMARY Population Estimate of a Subject's True Sensitivity Threshold to Maintain at the Same Dose Level During DBPCFC |
13 | — |
| PRIMARY Population Estimate of a Subject's True Sensitivity Threshold to Decrease by One Dose Level of During the DBPCFC |
14 | — |
| SECONDARY Number of Participants With Adverse Events and Serious Adverse Events During the Study. |
53; 0 | — |
| SECONDARY Number of Participants With Gastrointestinal and Possible Gastrointestinal Eosinophilic Adverse Events. |
16; 2 | — |
| SECONDARY Change in Peanut Skin Test Wheal Over Time Among Subjects Who Were Induced With Clinical Desensitization Versus Those Who Failed |
14.5; 16.25; 7.25; 9.25 | — |
| SECONDARY Change in Peanut IgE Over Time Among Subjects Who Were Induced With Clinical Desensitization Versus Those Who Failed |
107; 84.7; 12.1; 11.2 | — |
| SECONDARY Change in Peanut IgG4 Over Time Among Subjects Who Were Induced With Clinical Desensitization Versus Those Who Failed |
0.47; 0.37; 9.69; 4.39 | — |
Summary
The goal of this study will be to increase the reaction threshold (desensitization) of peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance).
Eligibility Criteria
Inclusion Criteria
- Between ages 1 year to 12 years exclusive
- Peanut specific IgE > 0.35kU/L or a convincing clinical history of an allergic reaction to peanut within 1 hour of ingestion
- Positive entry DBPCFC to 1 gram of peanut protein
Exclusion Criteria
- History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations < 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
- Participation in any interventional study for the treatment of food allergy in the past 6 months
- Known oat, wheat, or glycerin allergy
- Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
- Severe asthma (2007 National Heart Lung and Blood Institute (NHLBI) guidelines Criteria Steps 5 or 6 - Appendix 2)
- Inability to discontinue antihistamines for skin testing and DBPCFCs
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
- Use of beta-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 make the subject unsuitable for induction of food reactions
Data sourced from ClinicalTrials.gov (NCT01373242). 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.