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

Atopic Dermatitis Clinical Trial

— ADorable-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735483
• Other study ID #: 18266
• Secondary ID: J2T-MC-KGBJ/DRM0
• Status: Recruiting
• Phase: Phase 3
• Start date: March 9, 2023
• Est. completion date: June 26, 2026

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 26, 2026
• Est. primary completion date: June 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

Inclusion Criteria:

• Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI.

• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Lebrikizumab
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	CONEXA Investigacion Clinica S.A.	Buenos Aires
Argentina	Fundacion Cidea	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Fundación Respirar	Buenos Aires
Argentina	Instituto de Neumonología Y Dermatología	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Psoriahue	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Fundacion Estudios Clinicos	Rosario	Santa Fe
Australia	Cornerstone Dermatology	Coorparoo	Queensland
Australia	Sydney Children's Hospital	Randwick	New South Wales
Australia	The Children's Hospital at Westmead	Westmead	New South Wales
Australia	Veracity Clinical Research Pty Ltd	Woolloongabba	Queensland
Brazil	Fundação Pio XII - Hospital de Câncer de Barretos	Barretos	São Paulo
Brazil	Centro de Pesquisa Sao Lucas	Campinas	São Paulo
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Ribeirão Preto	Ribeirão Preto	São Paulo
Brazil	IBPClin - Instituto Brasil de Pesquisa Clínica	Rio de Janeiro
Brazil	Faculdade de Medicina do ABC	Santo Andre	São Paulo
Brazil	Pesquisare Saude	Santo André	São Paulo
Brazil	Clinica de Alergia Martti Antila	Sorocaba	São Paulo
Canada	Dermatology Research Institute	Calgary	Alberta
Canada	Alberta Dermasurgery Centre	Edmonton	Alberta
Canada	DermEdge Research	Mississauga	Ontario
Czechia	Detska nemocnice FN Brno	Brno	Brno-mesto
Czechia	Fakultni nemocnice Bulovka	Prague	Praha 8
France	Hôpital Saint Vincent-de-Paul	Lille	Nord-Pas-de-Calais
France	Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu	Nantes	Loire-Atlantique
France	Hôpitaux Drôme Nord - Romans	Romans-sur-Isère	Drôme
France	CHU de Toulouse - Hopital Larrey	Toulouse	Midi-Pyrénées
Germany	Fachklinik Bad Bentheim	Bad Bentheim	Niedersach
Germany	Rosenpark Research GmbH	Darmstadt	Hessen
Germany	Universitaetsklinikum Carl Gustav Carus Dresden	Dresden	Sachsen
Germany	Universitätsklinikum Frankfurt	Frankfurt	Hessen
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Japan	Asahikawa Medical College Hospital	Asahikawa	Hokkaido
Japan	Fukuyama City Hospital	Fukuyama	Hiroshima
Japan	Osaka Habikino Medical Center	Habikino	Osaka
Japan	Hiroshima University Hospital	Hiroshima
Japan	Ina Central Hospital	Ina	Nagano
Japan	Enomoto Clinic	Kumagaya	Saitama
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama
Japan	National Hospital Organization Sagamihara National Hospital	Sagamihara	Kanagawa
Japan	Kume Clinic	Sakai City	Osaka
Japan	Sugamo Sengoku Dermatology	Toshima	Tokyo
Japan	Fujita Health University	Toyoake	Aichi
Mexico	Scientia Investigacion Clinica S.C.	Chihuahua
Mexico	PanAmerican Clinical Research - Cuernavaca	Cuernavaca	Morelos
Mexico	Hospital de Jesús Nazareno	Mexico City	Distrito Federal
Mexico	Hospital Infantil de Mexico Federico Gomez	Mexico City	Distrito Federal
Mexico	Trials in Medicine	Mexico City	Distrito Federal
Mexico	Eukarya PharmaSite	Monterrey	Nuevo León
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Arké SMO S.A de C.V	Veracruz
Mexico	Instituto Dermatologico de Jalisco	Zapopan	Jalisco
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	Diamond Clinic	Krakow	Malopolski
Poland	DERMED Centrum Medyczne Sp. z o.o.	Lodz	Lódzkie
Poland	Centrum Medyczne Evimed	Warsaw	Mazowieckie
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona [Barcelona]
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las	Las Palmas
Spain	Grupo Pedro Jaén	Madrid
Spain	Hospital Infantil Universitario Niño Jesús	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital de Manises	Manises	València
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	CHOP-Centro De Especialidades De Mollabao	Pontevedra	Pontevedra [Pontevedra]
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid
Taiwan	National Taiwan University Hospital - Hsinchu branch	Hsinchu
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung City	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan
United States	Oakland Hills Dermatology	Auburn Hills	Michigan
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	The University of Texas Health Science Center at Houston	Bellaire	Texas
United States	Clinical Research Center of Alabama	Birmingham	Alabama
United States	Treasure Valley Medical Research	Boise	Idaho
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University	Chicago	Illinois
United States	Wright State Physicians	Fairborn	Ohio
United States	UConn Health	Farmington	Connecticut
United States	First OC Dermatology	Fountain Valley	California
United States	Solutions Through Advanced Research	Jacksonville	Florida
United States	Antelope Valley Clinical Trials	Lancaster	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Dermatology Research Associates	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Arkansas Research Trials	North Little Rock	Arkansas
United States	Allergy and Asthma Specialist	Owensboro	Kentucky
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Integrative Skin Science and Research - Location 2	Sacramento	California
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas
United States	ForCare Clinical Research	Tampa	Florida
United States	Respiratory Medicine Research Institute of Michigan, PLC	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Czechia,  France,  Germany,  Japan,  Mexico,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)		Baseline through Week 52
Secondary	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		Baseline to Week 52
Secondary	Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) from Baseline of Study KGBI by Visit in Study KGBJ		Baseline to Week 52
Secondary	Percentage of Participants Achieving EASI-90 from Baseline of Study KGBI by Visit in Study KGBJ		Baseline to Week 52
Secondary	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		Baseline to Week 52
Secondary	Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score		Baseline, Week 52
Secondary	Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)		Baseline, Week 52
Secondary	Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI		Baseline, Week 52
Secondary	Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI		Baseline, Week 52
Secondary	Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)		Baseline, Week 52

External Links

•   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 (ADorable-2)