Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

Study Purpose

The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Year - 3 Years
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- Aged 1 through 3 years at Visit 1 (screening).

- Physician-diagnosed peanut allergy and following a strict peanut-free diet.

- Peanut-specific IgE > 0.7 kUA/L.

- A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).

- An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).

Key

Exclusion Criteria:

- Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.

- Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).

- Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).

- History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).

- Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.

- Uncontrolled persistent asthma.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07003919
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	DBV Technologies
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Allergy, Peanut Allergy

Additional Details

This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE). The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks. For participation eligibility, please refer to eligibility criteria section. Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Arms & Interventions

Arms

Experimental: DBPC Treatment Period: DBV712 250 mcg

Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.

Placebo Comparator: DBPC Treatment Period: Placebo

Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.

Experimental: Optional Open-Label Extension-Period: DBV712 250 mcg

The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo).

Interventions

Combination Product: - DBV712 250 mcg

DBV712 250 mcg epicutaneous system.

Combination Product: - Placebo

DBV712 matching placebo epicutaneous system.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

AllerVie Clinical Research, Birmingham 4049979, Alabama 4829764

Status

Recruiting

Address

AllerVie Clinical Research

Birmingham 4049979, Alabama 4829764, 35209

Site Contact

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