Език: EN EN
← Назад към резултатите
Активно (без набиране) Фаза 3 NCT05741476

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

Фаза 3 – широко изпитване преди одобрение
Заболявания: Allergy, Peanut

Спонсор: DBV Technologies

Налично на: БГ
Обобщение
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.
Описание
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). Participants with a peanut protein ED less than or equal to (≤) 100 milligram (mg) will be eligible for 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.
Кой може да участва
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. Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria: * Signed ICF by the participant's parent(s)/caregiver(s). This consent should be signed after completion of the procedures in the randomized, DBPC Treatment Period, and before any procedure in Open-label Extension Period begins. * 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. Key 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. Participants may not enter the Open-label Extension Period if they meet any of the following 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. Participants with other reported cases of severe anaphylaxis will be considered eligible to participate in the Open-label Extension Period, at the judgement of the Investigator. * Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.
Места на провеждане 9
Австралия (1)
DBV Investigative Site
Adelaide
Канада (1)
DBV Investigative Site
Vancouver , British Columbia
Франция (1)
DBV Investigative Site
Angers
Германия (1)
DBV Investigative Site
Düsseldorf
Ireland (1)
DBV Investigative Site
Cork
Нидерландия (1)
DBV Investigative Site
Rotterdam
Испания (1)
DBV Investigative Site
Madrid
Великобритания (1)
DBV Investigative Site
London
САЩ (1)
DBV Investigative Site
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
4 Years
Максимална възраст
7 Years
Здрави доброволци
Не
Начална дата
21.02.2023
Крайна дата
01.10.2029
Регистрационен номер
NCT05741476
Източник
anzctr
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.