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Активно (без набиране) Фаза 3 NCT05559359

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to

Фаза 3 – широко изпитване преди одобрение
Заболявания: Atopic Dermatitis Eczema

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).
Кой може да участва
Inclusion Criteria: * Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least, * 12 months if participants are ≥6 years of age * 6 months if participants are 2 to \<6 years of age * 3 months if participants are 6 months to \<2 years of age. * Have an EASI score ≥16 at the screening and baseline * Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline * Have ≥10% BSA of AD involvement at the screening and baseline. Exclusion Criteria: * Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study. * Treatment with the following prior to the baseline: * An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer. * Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%. * Treatment with a topical investigational drug within 2 weeks prior to the baseline. * Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
Места на провеждане 12
Argentina (1)
CONEXA Investigacion Clinica S.A.
Buenos Aires
Австралия (1)
Cornerstone Dermatology
Coorparoo
Бразилия (1)
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos
Канада (1)
Dermatology Research Institute
Calgary
Чехия (1)
Fakultni nemocnice Bulovka
Prague
Германия (1)
Fachklinik Bad Bentheim
Bad Bentheim
Япония (1)
Asahikawa Medical University Hospital
Asahikawa
Mexico (1)
Scientia Investigacion Clinica S.C.
Chihuahua City
Полша (1)
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk
Испания (1)
Hospital Sant Joan de Déu
Esplugues de Llobregat
Taiwan (1)
National Taiwan University Hospital - Hsinchu branch
Hsinchu
САЩ (1)
Clinical Research Center of Alabama
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
6 Months
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
18.10.2022
Крайна дата
01.12.2026
Регистрационен номер
NCT05559359
Източник
anzctr
Запитване за медицински туризъм

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