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Active (not recruiting) Phase 3 NCT05559359

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

Phase 3 – large-scale trial before approval
Conditions: Atopic Dermatitis Eczema

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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).
Who can participate
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.
Locations 12
Argentina (1)
CONEXA Investigacion Clinica S.A.
Buenos Aires
Australia (1)
Cornerstone Dermatology
Coorparoo
Brazil (1)
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos
Canada (1)
Dermatology Research Institute
Calgary
Czech Republic (1)
Fakultni nemocnice Bulovka
Prague
Germany (1)
Fachklinik Bad Bentheim
Bad Bentheim
Japan (1)
Asahikawa Medical University Hospital
Asahikawa
Mexico (1)
Scientia Investigacion Clinica S.C.
Chihuahua City
Poland (1)
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk
Spain (1)
Hospital Sant Joan de Déu
Esplugues de Llobregat
Taiwan (1)
National Taiwan University Hospital - Hsinchu branch
Hsinchu
United States (1)
Clinical Research Center of Alabama
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Months
Maximum age
17 Years
Healthy volunteers
No
Start date
18.10.2022
Completion date
01.12.2026
Registry ID
NCT05559359
Source
anzctr
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