Phase 3
N=413
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
Peanut Allergy
Bottom Line
View on ClinicalTrials.gov: NCT03211247 ↗Enrolled (actual)
413
Serious AEs
5.8%
Results posted
Dec 2024
Primary outcome: Primary: Percentage of Treatment Responders at Month 12 — 67.0; 33.5; 52.4; 70.0 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Part A Viaskin Peanut 250 mcg (Biological); Part A Viaskin Peanut 100 mcg (Biological); Part A Placebo (Biological); Part B Viaskin Peanut 250 mcg (Biological); Part B Placebo (Biological)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- DBV Technologies
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Treatment Responders at Month 12 |
67.0; 33.5; 52.4; 70.0; 60.0 | <0.001 sig |
| SECONDARY Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model |
1010.31; 322.57; 788.74; 1155.90; 1153.47 | — |
| SECONDARY Change From Baseline in CRD of Peanut Protein to Month 12 |
1300.0; 0.0; 540.0; 1250.0; 1000.0 | — |
| SECONDARY ED of Peanut Protein at Month 12 Using ANCOVA Model |
659.36; 223.12; 526.31; 730.38; 760.60 | — |
| SECONDARY Change From Baseline in ED of Peanut Protein to Month 12 |
900.0; 0.0; 700.0; 700.0; 700.0 | — |
| SECONDARY Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge |
0; 0; 7.0; 7.6; 68.4; 67.8 | — |
Summary
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
Eligibility Criteria
Key Inclusion Criteria
- Male or female from 1-3 years of age;
- Physician-diagnosed peanut allergy;
- Peanut-specific IgE level > 0.7 kU/L;
- Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
- Positive DBPCFC at ≤ 300 mg peanut protein;
Key Exclusion Criteria
- Uncontrolled asthma;
- History of severe anaphylaxis to peanut;
- Prior immunotherapy to any food or other immunotherapy;
- Generalized severe dermatologic disease;
Data sourced from ClinicalTrials.gov (NCT03211247). 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.