Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
- Conditions
- Peanut Allergy
- Interventions
- Biological: Part A Viaskin Peanut 250 mcgBiological: Part A Viaskin Peanut 100 mcgBiological: Part A PlaceboBiological: Part B Viaskin Peanut 250 mcgBiological: Part B Placebo
- Registration Number
- NCT03211247
- Lead Sponsor
- DBV Technologies
- Brief 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).
- Detailed Description
The study comprised of two parts:
* In part A, subjects were randomized to receive either Viaskin Peanut 250 mcg, or Viaskin Peanut 100 mcg or the placebo in a 2:1 ratio, for 12 months. After 3 months of treatment, a data safety monitoring board had to determine the active dose to be applyed during the part B
* In Part B, subjects were randomized to receive either Viaskin Peanut 250 mcg or the placebo in a 2:1 ratio, for 12 months
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 414
- 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
- Uncontrolled asthma;
- History of severe anaphylaxis to peanut;
- Prior immunotherapy to any food or other immunotherapy;
- Generalized severe dermatologic disease;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A Viaskin Peanut 250 mcg Part A Viaskin Peanut 250 mcg - Part A Viaskin Peanut 100 mcg Part A Viaskin Peanut 100 mcg - Part A Placebo Part A Placebo - Part B Viaskin Peanut 250 mcg Part B Viaskin Peanut 250 mcg - Part B Placebo Part B Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Treatment Responders at Month 12 Month 12 A participant was defined as a treatment responder if the initial eliciting dose (ED) was \> 10 milligram (mg) peanut protein and the ED was ≥1000 mg peanut protein at the post-treatment double-blind placebo-controlled food challenge (DBPCFC) at Month 12 OR the initial ED at baseline was ≤10 mg peanut protein and the ED was ≥300 mg peanut protein at the post-treatment DBPCFC at Month 12.
- Secondary Outcome Measures
Name Time Method Cumulative Reactive Dose (CRD) of Peanut Protein at Month 12 Using Analysis of Covariance (ANCOVA) Model Month 12 The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows:
If the ED reported by the investigator in the electronic case report form (eCRF) is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses. The CRD in each treatment group at Month 12 was compared using ANCOVA model.Change From Baseline in CRD of Peanut Protein to Month 12 Baseline (Day 1) and Month 12 The peanut protein CRD was defined as the sum of all peanut protein doses taken by the participant during the DBPCFC, calculated as follows:
If the ED reported by the investigator in the eCRF is missing, then the CRD is missing; If the ED reported by the investigator in the eCRF was not missing then the CRD was calculated as the sum of all doses given, including also the partial doses.ED of Peanut Protein at Month 12 Using ANCOVA Model Month 12 The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge. The ED in each treatment group at Month 12 was compared using ANCOVA model.
Change From Baseline in ED of Peanut Protein to Month 12 Baseline (Day 1) and Month 12 The peanut protein ED was the individual dose of peanut protein administered to participants during the food challenge procedure, which triggered objective allergic reactions, leading to stopping the challenge.
Percentage of Participants With Severity of Objective Symptoms at Baseline and Month 12 During Double-Blind Placebo-Controlled Food Challenge Baseline (Day 1) and Month 12 The objective symptoms collected during the DBPCFC included skin (erythematous rash, pruritus, urticaria/angioedema, rash), upper respiratory (sneezing/itching, nasal congestion, rhinorrhea, laryngeal), lower respiratory (wheezing), gastrointestinal (diarrhea, vomiting, cardiovascular), and eyes (conjunctivitis, any other objective symptoms), with the exception of erythematous rash (recorded as Yes/No), each symptom was graded as: 0=" absent",1=" mild", 2=" moderate" or 3=" severe". For erythematous rash, the percent area involved was collected. Percentages were calculated based on the number of participants in each time point. Subjective abdominal pain (when graded 2 or 3) was also considered for this analysis.
Trial Locations
- Locations (51)
University of Rochester
🇺🇸Rochester, New York, United States
University of California School of Medicine
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of California, Rady Children's Hospital
🇺🇸San Diego, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Ann & Robert H. Lurie Children's Hospital of CHicago
🇺🇸Chicago, Illinois, United States
The Universal of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Riley Hospital for Children at Indiana University
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Boston Childrens' Hospital
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Children's Medical Center of Dallas
🇺🇸Dallas, Texas, United States
ASTHMA, Inc.
🇺🇸Seattle, Washington, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Baylor College of Medicine - Texas Children's Hospital
🇺🇸Houston, Texas, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of Arizona Health Science
🇺🇸Tucson, Arizona, United States
Stanford University School of Medicine
🇺🇸Stanford, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's national Health System
🇺🇸Washington, District of Columbia, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
The University of North Carolina - Chapell Hill
🇺🇸Chapel Hill, North Carolina, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
The Children's Hospital at Westmead
🇦🇺Westmead, New South Wales, Australia
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
Sydney Children's Hospital
🇦🇺Randwick, NWS, Australia
Queensland Children's Hospital
🇦🇺South Brisbane, Queensland, Australia
The Women's and children's hospital
🇦🇺North Adelaide, South Australia, Australia
British Columbia Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
The Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Perth Children's Hospital
🇦🇺Nedlands, Western Australia, Australia
CHUM & CHU Sainte-Justine
🇨🇦Montréal, Quebec, Canada
Hopital Necker
🇫🇷Paris, France
CHRU Metz-Thionville
🇫🇷Metz, France
Universitatsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Hopitaux Pediatriques de Nice
🇫🇷Nice, France
CHRU Lille
🇫🇷Lille, France
Cork University Hospital
🇮🇪Cork, Ireland
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
CHRU Nancy
🇫🇷Vandoeuvre les nancy, France
Erasmus MC Sophia Children's Hospital
🇳🇱Rotterdam, Netherlands
Universitatklinikum Giessen und Marburg
🇩🇪Marburg, Germany
St.Mary's Hospital
🇬🇧London, United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
Sheffield Children's Hospital
🇬🇧Sheffield, United Kingdom
ROyal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
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