Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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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 | 4 Years - 7 Years |
| Gender | All |
Key
Inclusion Criteria:
- - Aged 4 through 7 years at Visit 1 (screening).
- - Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
- - Peanut-specific IgE of >0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
- - An ED of ≤100 mg peanut protein at screening DBPCFC.
inclusion criteria:
- - Signed ICF by the participant's parent(s)/caregiver(s).
- - Participants who perform the peanut DBPCFC at the end of Month 12 and have ≥80% compliance with investigational medicinal product (IMP).
- - Parent(s)/caregiver(s) and participants willing to comply with all study requirements during the participant's participation in the study.
Exclusion Criteria:
- - Severe generalized dermatologic disease involving the application area (interscapular region) - Uncontrolled persistent asthma.
- - Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
- - Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
exclusion criteria:
- - Participants who develop a severe anaphylactic reaction during the DBPCFC at the end of Month 12 with the event requiring tracheal intubation or leading to a cardiac arrest and/or to coma.
- - Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.
Trial Details
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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. |
NCT05741476 |
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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 |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
DBV Technologies |
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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 |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Australia, Canada, France, Germany, Ireland, Netherlands, Spain, United Kingdom, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Allergy, Peanut |
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:
- - Assessment of peanut skin prick test (SPT) and serum peanut immunoglobulin-E (IgE) - Peanut double-blind placebo-controlled food challenge (DBPCFC) to confirm peanut allergy and establish an entry peanut eliciting dose (ED).
Arms
Experimental: DBPC Treatment Period: DBV712 250 mcg
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).
Placebo Comparator: DBPC Treatment Period: Placebo
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).
Experimental: Open Label Extension Period: DBV712 250 mcg
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).
Interventions
Drug: - DBV712
DBV712 250 mcg epicutaneous system.
Other: - Placebo
DBV712 matching placebo epicutaneous system.
Drug: - DBV712
DBV712 250 mcg 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.
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Birmingham 4049979, Alabama 4829764, 35233
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Tucson 5318313, Arizona 5551752, 85724
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Little Rock 4119403, Arkansas 4099753, 72202
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Los Angeles 5368361, California 5332921, 90027
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Los Angeles 5368361, California 5332921, 90095
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Mission Viejo 5373763, California 5332921, 92691
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San Diego 5391811, California 5332921, 92123
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San Francisco 5391959, California 5332921, 94158
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San Jose 5392171, California 5332921, 95117
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Aurora 5412347, Colorado 5417618, 80045
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Colorado Springs 5417598, Colorado 5417618, 80907
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Washington D.C. 4140963, District of Columbia 4138106, 20010
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Hollywood 4158928, Florida 4155751, 33021
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Miami 4164138, Florida 4155751, 33136
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St. Petersburg 4171563, Florida 4155751, 33701
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Tampa 4174757, Florida 4155751, 33613
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Atlanta 4180439, Georgia 4197000, 30329
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Marietta 4207783, Georgia 4197000, 30060
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Chicago 4887398, Illinois 4896861, 60611
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Normal 4903780, Illinois 4896861, 61761
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Indianapolis 4259418, Indiana 4921868, 46202
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Louisville 4299276, Kentucky 6254925, 40215
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Baltimore 4347778, Maryland 4361885, 21287
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Chevy Chase 4351335, Maryland 4361885, 20815
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Boston 4930956, Massachusetts 6254926, 02114
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Boston 4930956, Massachusetts 6254926, 02115
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Taunton 4952629, Massachusetts 6254926, 02780
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Ann Arbor 4984247, Michigan 5001836, 48106
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Ypsilanti 5015688, Michigan 5001836, 48197
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Kansas City 4393217, Missouri 4398678, 64108
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Great Neck 5119218, New York 5128638, 11021
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New York 5128581, New York 5128638, 10016
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New York 5128581, New York 5128638, 10029
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Rochester 5134086, New York 5128638, 14642
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Columbus 4509177, Ohio 5165418, 43205
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Pittsburgh 5206379, Pennsylvania 6254927, 15224
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Memphis 4641239, Tennessee 4662168, 38105
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Austin 4671654, Texas 4736286, 78723
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Dallas 4684888, Texas 4736286, 75235
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Houston 4699066, Texas 4736286, 77030
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Seattle 5809844, Washington 5815135, 98101
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Seattle 5809844, Washington 5815135, 98115
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Milwaukee 5263045, Wisconsin 5279468, 53226
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Hamilton 5969782, , L8SIG5
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Angers 3037656, France, 49933
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Brest 3030300, France, 29609
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Bron 3029931, France, 69500
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Strasbourg 2973783, France, 67091
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Ulm 2820256, Germany, 89075
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Cork 2965140, Ireland, T12 DC4A
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Dublin 2964574, Ireland, D12N512
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Rotterdam 2747891, Netherlands, 3015 CN
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Utrecht 2745912, Netherlands, 3584 EA
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Madrid 3117735, Spain, 28009
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Madrid 3117735, Spain, 28034
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Málaga 2514256, Spain, CP 29011
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London 2643743, , SE1 7ETH
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London 2643743, , W2 1NY
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Manchester 2643123, , M13 9WL
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Sheffield 2638077, , S10 2TH
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Southampton 2637487, , SO16 6YD
