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| ID | Type | Description | Link |
|---|---|---|---|
| EU CTIS | Other Identifier | 2022-502110-85-00 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBPC Treatment Period: DBV712 250 mcg | Experimental | 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). |
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| DBPC Treatment Period: Placebo | Placebo Comparator | 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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| Open Label Extension Period: DBV712 250 mcg | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBV712 | Drug | DBV712 250 mcg epicutaneous system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Month 12 |
| DBPC Treatment Period: Eliciting Dose (ED) of Peanut Protein |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DBV Investigative Site | Birmingham | Alabama | 35233 | United States | ||
| DBV Investigative Site |
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| Placebo | Other | DBV712 matching placebo epicutaneous system. |
|
| DBV712 | Drug | DBV712 250 mcg epicutaneous system. |
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| 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 | 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. | Baseline up to Month 12 |
| Screening up to 56 months. |
| Number of Participants With Systemic Allergic Reactions | Number of participants with systemic allergic reactions will be reported. | 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). | Screening up to 56 months. |
| Tucson |
| Arizona |
| 85724 |
| United States |
| DBV Investigative Site | Little Rock | Arkansas | 72202 | United States |
| DBV Investigative Site | Los Angeles | California | 90027 | United States |
| DBV Investigative Site | Los Angeles | California | 90095 | United States |
| DBV Investigative site | Mission Viejo | California | 92691 | United States |
| DBV Investigative Site | San Diego | California | 92123 | United States |
| DBV Investigative Site | San Francisco | California | 94158 | United States |
| DBV Investigative Site | San Jose | California | 95117 | United States |
| DBV Investigative Site | Aurora | Colorado | 80045 | United States |
| DBV Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| DBV Investigative Site | Washington D.C. | District of Columbia | 20010 | United States |
| DBV Investigative Site | Hollywood | Florida | 33021 | United States |
| DBV Investigative Site | Miami | Florida | 33136 | United States |
| DBV Investigative Site | St. Petersburg | Florida | 33701 | United States |
| DBV Investigative Site | Tampa | Florida | 33613 | United States |
| DBV Investigative site | Atlanta | Georgia | 30329 | United States |
| DBV Investigative Site | Marietta | Georgia | 30060 | United States |
| DBV Investigative Site | Chicago | Illinois | 60611 | United States |
| DBV Investigative Site | Normal | Illinois | 61761 | United States |
| DBV Investigative Site | Indianapolis | Indiana | 46202 | United States |
| DBV Investigative Site | Louisville | Kentucky | 40215 | United States |
| DBV Investigative Site | Baltimore | Maryland | 21287 | United States |
| DBV Investigative Site | Chevy Chase | Maryland | 20815 | United States |
| DBV Investigative Site | Boston | Massachusetts | 02114 | United States |
| DBV Investigative Site | Boston | Massachusetts | 02115 | United States |
| DBV Investigative Site | Taunton | Massachusetts | 02780 | United States |
| DBV Investigative Site | Ann Arbor | Michigan | 48106 | United States |
| DBV Investigative Site | Ypsilanti | Michigan | 48197 | United States |
| DBV Investigative Site | Maplewood | Minnesota | 55109 | United States |
| DBV Investigative Site | Kansas City | Missouri | 64108 | United States |
| DBV Investigative Site | Great Neck | New York | 11021 | United States |
| DBV Investigative Site | New York | New York | 10016 | United States |
| DBV Investigative Site | New York | New York | 10029 | United States |
| DBV Investigative Site | Rochester | New York | 14642 | United States |
| DBV Investigative Site | Chapel Hill | North Carolina | 27599 | United States |
| DBV Investigative Site | Cincinnati | Ohio | 45229 | United States |
| DBV Investigative Site | Cleveland | Ohio | 44106 | United States |
| DBV Investigative Site | Cleveland | Ohio | 44195 | United States |
| DBV Investigative Site | Columbus | Ohio | 43205 | United States |
| DBV Investigative Site | Philadelphia | Pennsylvania | 19104 | United States |
| DBV Investigative Site | Pittsburgh | Pennsylvania | 15224 | United States |
| DBV Investigative Site | Memphis | Tennessee | 38105 | United States |
| DBV Investigative Site | Nashville | Tennessee | 37232 | United States |
| DBV Investigative Site | Austin | Texas | 78723 | United States |
| DBV Investigative Site | Dallas | Texas | 75235 | United States |
| DBV Investigative Site | Houston | Texas | 77030 | United States |
| DBV Investigative Site | Seattle | Washington | 98101 | United States |
| DBV Investigative Site | Seattle | Washington | 98115 | United States |
| DBV Investigative Site | Milwaukee | Wisconsin | 53226 | United States |
| DBV Investigative Site | Adelaide | 5006 | Australia |
| DBV Investigative Site | Nedlands | 6009 | Australia |
| DBV Investigative Site | Parkville | 3052 | Australia |
| DBV Investigative Site | Richmond | 3121 | Australia |
| DBV Investigative Site | South Brisbane | 4101 | Australia |
| DBV Investigative Site | Westmead | 2145 | Australia |
| DBV Investigative Site | Vancouver | British Columbia | V6H 3V4 | Canada |
| DBV Investigative Site | Winnipeg | Manitoba | R3J 0S9 | Canada |
| DBV Investigative Site | Burlington | Ontario | L7L6W6 | Canada |
| DBV Investigative Site | North York | Ontario | M3B3S6 | Canada |
| DBV Investigative Site | Ottawa | Ontario | M5G 1X8 | Canada |
| DBV Investigative Site | Toronto | Ontario | K1H1E4 | Canada |
| DBV Investigative Site | Montreal | Quebec | H3T 1C5 | Canada |
| DBV Investigative Site | Montreal | Quebec | H4A3J1 | Canada |
| DBV Investigative Site | Québec | Quebec | G1v4W2 | Canada |
| DBV Investigative Site | Hamilton | L8SIG5 | Canada |
| DBV Investigative Site | Angers | 49933 | France |
| DBV Investigative Site | Brest | 29609 | France |
| DBV Investigative Site | Bron | 69500 | France |
| DBV Investigative Site | Nice | 06200 | France |
| DBV Investigative Site | Strasbourg | 67091 | France |
| DBV Investigative Site | Vandœuvre-lès-Nancy | 54511 | France |
| DBV Investigative Site | Düsseldorf | 40217 | Germany |
| DBV Investigative Site | Frankfurt | 60590 | Germany |
| DBV Investigative Site | Ulm | 89075 | Germany |
| DBV Investigative Site | Cork | T12 DC4A | Ireland |
| DBV Investigative Site | Dublin | D12N512 | Ireland |
| DBV Investigative Site | Rotterdam | 3015 CN | Netherlands |
| DBV Investigative Site | Utrecht | 3584 EA | Netherlands |
| DBV Investigative Site | Madrid | 28009 | Spain |
| DBV Investigative Site | Madrid | 28034 | Spain |
| DBV Investigative Site | Málaga | CP 29011 | Spain |
| DBV Investigative Site | London | SE1 7ETH | United Kingdom |
| DBV Investigative Site | London | W2 1NY | United Kingdom |
| DBV Investigative Site | Manchester | M13 9WL | United Kingdom |
| DBV Investigative Site | Sheffield | S10 2TH | United Kingdom |
| DBV Investigative Site | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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