Clinical trial NCT05735483: A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Official title: A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Atopic Dermatitis
Eczema
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 310
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis.

This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.


Eligibility criteria: Inclusion Criteria:

* Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
* For female participants of childbearing potential, highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria:

* Developed an serious adverse events (SAE) during their participation in parent study KGBI deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
* Developed an AE during their participation in the study KGBI that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant.
* Met the criteria for permanent study intervention discontinuation in study KGBI, if deemed related to lebrikizumab or led to investigator- or sponsor-initiated withdrawal of participant from the study (for example, noncompliance, inability to complete study assessments, etc.)

Note: If study KGBI is still blinded at the time of rollover to study KGBJ, conditions deemed related to the study treatment will be considered related to lebrikizumab.

* Are pregnant or breastfeeding or are planning to become pregnant or breastfeed during the study.

Primary outcomes:
measure: Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
timeFrame: Baseline through Week 52
Secondary outcomes:
measure: Percentage of Participants with an Investigator's Global Assessment (IGA) Score 0 or 1 and a Reduction ≥2 Points from Baseline of Study KGBI by Visit in Study KGBJ
timeFrame: Baseline to Week 52
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ
timeFrame: Baseline to Week 52
measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ
timeFrame: Baseline to Week 52
measure: Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline of Study KGBI who Achieve a ≥4-point Reduction from Baseline of Study KGBI by Visit in Study KGBJ
timeFrame: Baseline to Week 52
measure: Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score
timeFrame: Baseline, Week 52
measure: Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)
timeFrame: Baseline, Week 52
measure: Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
timeFrame: Baseline, Week 52
measure: Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
timeFrame: Baseline, Week 52
measure: Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)
timeFrame: Baseline, Week 52
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: 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: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
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: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
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 Aire
country: Argentina
facility: Instituto de Neumonología Y Dermatología
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Psoriahue
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
state: Ciudad Autónoma De 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: 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 Pty Ltd
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: Santo André
country: Brazil
facility: Pesquisare Saude
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: Romans-sur-Isère
country: France
facility: Hôpitaux Drôme Nord - Romans
state: Drôme
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
state: Loire-Atlantique
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Larrey
state: Midi-Pyrénées
city: Lille
country: France
facility: Hôpital Saint Vincent-de-Paul
state: Nord-Pas-de-Calais
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: Niedersach
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: Małopolski
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: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Pontevedra
country: Spain
facility: CHOP-Centro De Especialidades De Mollabao
state: Pontevedra [Pontevedra]
city: Manises
country: Spain
facility: Hospital de Manises
state: València
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: 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: