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 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening up to 56 months.

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).

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