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Allergen-Specific Immunotherapy

Viaskin Peanut for Peanut Allergy (VITESSE Trial)

Phase 3
Waitlist Available
Research Sponsored by DBV Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening up to 56 months.
Awards & highlights
Pivotal Trial

Summary

This trial tests if a daily dose of a drug can help children with peanut allergies become less sensitive to it over a year.

Who is the study for?
This trial is for peanut-allergic children aged 4-7 who react to a very small amount of peanut protein and are on a strict peanut-free diet. They must have certain levels of peanut-specific antibodies and skin test reactions. Kids with uncontrolled asthma, past immunotherapy for peanuts, or recent biologic treatments can't join.
What is being tested?
The study tests the safety and effectiveness of DBV712 (250 mcg), a daily treatment aimed at desensitizing children to peanuts over one year. The comparison is made against a placebo—a substance with no active drug—to see if DBV712 makes any difference.
What are the potential side effects?
Possible side effects include local skin reactions where the patch is applied, such as redness or itching. There may also be systemic allergic responses due to exposure to the allergen in the treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening up to 56 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to 56 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group
Secondary study objectives
DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein
DBPC Treatment Period: Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
Other study objectives
Number of Participants With Systemic Allergic Reactions
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)
Total Score for Scoring Atopic Dermatitis (SCORAD)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Open Label Extension Period: DBV712 250 mcgExperimental Treatment1 Intervention
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 2 additional years if they were randomized DBV712 250 mcg or for 3 years if they were randomized placebo. After 12 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 24), participants will undergo a peanut DBPCFC according to the following schedule: 3, 10, 30, 100, 300, 600, 1000, and 2000 mg (4043 mg cumulative dose). Participants who were randomized to placebo will also undergo an additional peanut DBPCFC after 24 months of open-label treatment with DBV712 250 mcg, (i.e., at the end of Month 36).
Group II: DBPC Treatment Period: DBV712 250 mcgExperimental Treatment1 Intervention
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).
Group III: DBPC Treatment Period: PlaceboPlacebo Group1 Intervention
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 12 months. At Month 12, a post-treatment peanut DBPCFC will be performed, with a starting dose of 3 mg peanut protein with escalation to the highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, and 1,000 mg (2,043 mg cumulative dose).

Find a Location

Who is running the clinical trial?

DBV TechnologiesLead Sponsor
16 Previous Clinical Trials
2,922 Total Patients Enrolled

Media Library

DBV712 (Allergen-Specific Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05741476 — Phase 3
Peanut Allergy Research Study Groups: DBPC Treatment Period: DBV712 250 mcg, DBPC Treatment Period: Placebo, Open Label Extension Period: DBV712 250 mcg
Peanut Allergy Clinical Trial 2023: DBV712 Highlights & Side Effects. Trial Name: NCT05741476 — Phase 3
DBV712 (Allergen-Specific Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741476 — Phase 3
~225 spots leftby Nov 2025
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