Clinical trial NCT05559359: A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Dermira, Inc.
First posted: 2022-09-29
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline
timeFrame: Baseline to Week 16
measure: Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score
timeFrame: Baseline to Week 16
measure: Percentage Change from Baseline in EASI Score
timeFrame: Baseline, Week 16
measure: Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline
timeFrame: Baseline to Week 16
measure: Percentage Change from Baseline in Pruritus NRS Score
timeFrame: Baseline, Week 16
measure: Change from Baseline in Children Dermatology Life Quality Index (cDLQI)
timeFrame: Baseline, Week 16
measure: Percentage of Participants with a Pruritus NRS Score of ≥4 points at Baseline Who Achieve Both EASI-75 and a ≥4-point Reduction in Pruritus NRS Score from Baseline
timeFrame: Baseline to Week 16
measure: Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)
timeFrame: Baseline, Week 16
measure: Change from Baseline in Body Surface Area (BSA)
timeFrame: Baseline, Week 16
measure: Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score
timeFrame: Baseline to Week 16
measure: Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration
timeFrame: Week 14
measure: Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
timeFrame: Week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Research Center of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Research Trials
state: Arkansas
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research - Location 2
state: California
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Owensboro
country: United States
facility: Allergy and Asthma Specialist
state: Kentucky
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan, PLC
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonología Y Dermatología
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Psoriahue
state: Buenos Aires
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: CONEXA Investigacion Clinica S.A.
city: Buenos Aires
country: Argentina
facility: Fundación Respirar
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Coorparoo
country: Australia
facility: Cornerstone Dermatology
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: São Paulo
city: Campinas
country: Brazil
facility: Centro de Pesquisa Sao Lucas
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital de Clínicas de Ribeirão Preto
state: São Paulo
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin - Instituto Brasil de Pesquisa Clínica
city: Calgary
country: Canada
facility: Dermatology Research Institute
state: Alberta
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: Brno
country: Czechia
facility: Detska nemocnice FN Brno
state: Brno-město
city: Prague
country: Czechia
facility: Fakultni nemocnice Bulovka
state: Praha 8
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
state: Hessen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
state: Niedersachsen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Toyoake
country: Japan
facility: Fujita Health University
state: Aichi
city: Fukuyama
country: Japan
facility: Fukuyama City Hospital
state: Hiroshima
city: Asahikawa
country: Japan
facility: Asahikawa Medical College Hospital
state: Hokkaido
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Ina
country: Japan
facility: Ina Central Hospital
state: Nagano
city: Habikino
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Sakai City
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Kumagaya
country: Japan
facility: Enomoto Clinic
state: Saitama
city: Toshima
country: Japan
facility: Sugamo Sengoku Dermatology
state: Tokyo
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine
city: Okayama
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
city: Mexico City
country: Mexico
facility: Hospital de Jesús Nazareno
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Trials in Medicine
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Instituto Dermatologico de Jalisco
state: Jalisco
city: Cuernavaca
country: Mexico
facility: PanAmerican Clinical Research - Cuernavaca
state: Morelos
city: Monterrey
country: Mexico
facility: Eukarya PharmaSite
state: Nuevo León
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica S.C.
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Warsaw
country: Poland
facility: Centrum Medyczne Evimed
state: Mazowieckie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Małopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Lodz
country: Poland
facility: "DERMED" Centrum Medyczne Sp. z o.o.
state: Łódzkie
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona [Barcelona]
city: Las
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Las Palmas
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Grupo Pedro Jaén
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taichung
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital - Hsinchu branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital-Taipei
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: