A Phase 3 interventional study of DBV712 and Placebo in Allergy, Peanut, sponsored by DBV Technologies. Active, not recruiting at 87 sites in 9 countries. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by DBV Technologies · Phase 3, Interventional, and Treatment
The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.
This study is consisting of a 4-week Screening Period, 12-month DBPC Treatment Period and an open-label extension of either 24 or 36-months duration so that each participant may have the opportunity to receive DBV712 for a total duration of 36 months. Following 36 months of treatment with DBV712 250 mcg, sustained unresponsiveness (SU) will be evaluated by subsequent open food challenge(s) [FC(s)] at 2-, 4-, and 6-months off treatment.
Maximum participant participation will be either approximately 44 or 56 months, depending on the participant's randomized treatment assignment. During the 4-week Screening Period, participants are required to meet 2 sequential screening parameters to determine eligibility prior to randomization:
The starting dose of the eligibility peanut DBPCFC will be 1 mg peanut protein and will escalate up to a highest single dose of 100 mg peanut protein (cumulative 144 mg) via the following schedule: 1, 3, 10, 30, 100 mg. Participants who react, with an eliciting dose (ED) (with dose-limiting symptoms) at or below the dose of 100 mg peanut protein will be considered eligible.
Randomization of eligible participants will occur in a 2:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.
166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.
This study's planned enrollment of 600 is above the median of 50 across 127 interventional studies indexed under Peanut Hypersensitivity.
Browse Peanut Hypersensitivity studies →DBV Technologies is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria:
Key Exclusion Criteria:
Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: DBV712
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).
Other: Placebo
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).
Drug: DBV712
DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group
A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was \> 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 250 mcg group compared to the placebo group after 12 months of treatment in the target population will be reported.
Time frame: At Month 12
DBPC Treatment Period: Cumulative Reactive Dose (CRD) of Peanut Protein
The Peanut Protein CRD is defined as the sum of all peanut protein doses taken by the participant during the DBPCFC (including the ED and any partial dose given before the reaction).
Time frame: At Month 12
DBPC Treatment Period: Eliciting Dose (ED) of Peanut Protein
Time frame: At Month 12
DBPC Treatment Period: Percentage of Participants with an Eliciting Dose (ED) ≥600 mg and ≥1,000 mg Peanut Protein at Month 12
Time frame: At Month 12
DBPC Treatment Period: Number of Participants by Maximum Severity of Allergic Reaction During the Peanut Oral Food Challenge
The maximum severity of allergic reaction will be assessed according to Consortium of Food Allergy Research (CoFAR) Grading Scale Version 3.0. The scale is Grade 1 (Mild) through 5, the higher the grade, the more severe the allergic reaction.
Time frame: Baseline up to Month 12
Number of Participants with Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)
An AE: any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAEs were defined as AEs that developed or worsened or became serious during on- treatment period. A serious TEAE: any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. AESI defined as: Local AESIs- severe local site reactions; systemic AESIs systemic allergic reactions, including those leading to epinephrine use, whatever the causal relationship to IP; AEs leading to epinephrine or inhaled or systemic corticosteroid use irrespective of the causal relationship to IP. TEAE's will include physical examination, vital signs, AEs leading to topical corticosteroid use, assessment of pain.
Time frame: Screening up to 56 months.
Number of Participants With Systemic Allergic Reactions
Number of participants with systemic allergic reactions will be reported.
Time frame: Screening up to 56 months.
Total Score for Scoring Atopic Dermatitis (SCORAD)
SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).
Time frame: Screening up to 56 months.
Ran from Feb 2023 to primary completion in Nov 2025, 32 months.
Of 15 phase 3 interventional studies under Peanut Hypersensitivity, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 42. This study's 32 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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