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| ID | Type | Description | Link |
|---|---|---|---|
| J2T-MC-KGBJ/DRM06-AD16 | Other Identifier | Eli Lilly and Company | |
| 2022-501478-21-00 | Other Identifier | EU Trial Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab | Experimental | Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. |
|
| Lebrikizumab - Optional Extension Period (OEP) | Experimental | During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) | Baseline through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | United States | ||
| Phoenix Children's Hospital |
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| Label | URL |
|---|---|
| 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) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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All participants receive Lebrikizumab during the 16-week blinded treatment period. At Week 18, participants receive open-label lebrikizumab. From Week 52 onward, doses may be blinded or open-label.
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| Placebo | Drug | Administered SC |
|
| Baseline to Week 52 |
| Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ | Baseline to Week 52 |
| 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 |
| Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score | Baseline, Week 52 |
| Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD) | Baseline, Week 52 |
| Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI | Baseline, Week 52 |
| Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI | Baseline, Week 52 |
| Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA) | Baseline, Week 52 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Arkansas Research Trials | North Little Rock | Arkansas | 72217 | United States |
| First OC Dermatology | Fountain Valley | California | 92708 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Integrative Skin Science and Research - Location 2 | Sacramento | California | 95815 | United States |
| UConn Health | Farmington | Connecticut | 06030 | United States |
| Solutions Through Advanced Research | Jacksonville | Florida | 32256 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Treasure Valley Medical Research | Boise | Idaho | 83706 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Allergy and Asthma Specialist | Owensboro | Kentucky | 42301 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Respiratory Medicine Research Institute of Michigan, PLC | Ypsilanti | Michigan | 48197 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Wright State Physicians | Fairborn | Ohio | 45324 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| The University of Texas Health Science Center at Houston | Bellaire | Texas | 77401 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| CONEXA Investigacion Clinica S.A. | Buenos Aires | Buenos Aires | 1012 | Argentina |
| Fundación Respirar | Buenos Aires | Buenos Aires | C1426ABP | Argentina |
| Instituto de Neumonología Y Dermatología | Ciudad Autonoma de Buenos Aire | Buenos Aires | 1425 | Argentina |
| Psoriahue | Ciudad Autonoma de Buenos Aire | Buenos Aires | C1425DKG | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Ciudad Autónoma de Buenos Aires | Buenos Aires | 1027 | Argentina |
| Fundacion Cidea | Buenos Aires | Buenos Aires F.D. | C1121ABE | Argentina |
| Fundacion Estudios Clinicos | Rosario | Santa Fe Province | S2000DEJ | Argentina |
| Sydney Children's Hospital | Randwick | New South Wales | 2031 | Australia |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Cornerstone Dermatology | Coorparoo | Queensland | 4151 | Australia |
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | 4102 | Australia |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | Rio de Janeiro | 20241-180 | Brazil |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | 14784400 | Brazil |
| Centro de Pesquisa Sao Lucas | Campinas | São Paulo | 13060-803 | Brazil |
| Hospital de Clínicas de Ribeirão Preto | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Faculdade de Medicina do ABC | Santo André | São Paulo | 09060-870 | Brazil |
| Pesquisare Saude | Santo André | São Paulo | 09080-110 | Brazil |
| Clinica de Alergia Martti Antila | Sorocaba | São Paulo | 18040-425 | Brazil |
| Dermatology Research Institute | Calgary | Alberta | T2J 7E1 | Canada |
| DermEdge Research | Mississauga | Ontario | L4Y 4C5 | Canada |
| Detska nemocnice FN Brno | Brno | Brno-město | 613 00 | Czechia |
| Fakultni nemocnice Bulovka | Prague | Praha 8 | 180 81 | Czechia |
| Hôpitaux Drôme Nord - Romans | Romans-sur-Isère | Drôme | 26102 | France |
| Hôpital Saint Vincent-de-Paul | Lille | Hauts-de-France | 59020 | France |
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu | Nantes | Loire-Atlantique | 44093 Cedex 1 | France |
| CHU de Toulouse - Hopital Larrey | Toulouse | Midi-Pyrénées | 31400 | France |
| Rosenpark Research GmbH | Darmstadt | Hesse | 64283 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | Hesse | 60590 | Germany |
| Fachklinik Bad Bentheim | Bad Bentheim | Niedersach | 48455 | Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden | Dresden | Saxony | 01307 | Germany |
| Fujita Health University | Toyoake | Aichi-ken | 470-1192 | Japan |
| Fukuyama City Hospital | Fukuyama | Hiroshima | 721-8511 | Japan |
| Hiroshima University Hospital | Hiroshima | Hiroshima | 734-8551 | Japan |
| Asahikawa Medical College Hospital | Asahikawa | Hokkaido | 078-8510 | Japan |
| National Hospital Organization Sagamihara National Hospital | Sagamihara | Kanagawa | 252-0315 | Japan |
| University Hospital,Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
| Ina Central Hospital | Ina | Nagano | 396-0033 | Japan |
| Okayama City General Medical Center Okayama City Hospital | Okayama | Okayama-ken | 700-8557 | Japan |
| Osaka Habikino Medical Center | Habikino | Osaka | 583-8588 | Japan |
| Dermatology and Ophthalmology Kume Clinic | Sakai | Osaka | 593-8324 | Japan |
| Enomoto Clinic | Kumagaya | Saitama | 360-0018 | Japan |
| Sugamo Sengoku Dermatology | Toshima City | Tokyo | 170-0002 | Japan |
| Scientia Investigacion Clinica S.C. | Chihuahua City | Chihuahua | 31207 | Mexico |
| Instituto Dermatologico de Jalisco | Zapopan | Jalisco | 45190 | Mexico |
| Hospital de Jesús Nazareno | Mexico City | Mexico City | 06090 | Mexico |
| Trials in Medicine | Mexico City | Mexico City | 06700 | Mexico |
| Hospital Infantil de Mexico Federico Gomez | Mexico City | Mexico City | 06720 | Mexico |
| PanAmerican Clinical Research - Cuernavaca | Cuernavaca | Morelos | 62290 | Mexico |
| Eukarya PharmaSite | Monterrey | Nuevo León | 64718 | Mexico |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 66460 | Mexico |
| Arké SMO S.A de C.V | Veracruz | Veracruz | 91910 | Mexico |
| Centrum Medyczne Evimed | Warsaw | Masovian Voivodeship | 02-625 | Poland |
| Diamond Clinic | Krakow | Małopolski | 31-559 | Poland |
| Centrum Badan Klinicznych PI-House sp. z o.o. | Gdansk | Pomeranian Voivodeship | 80-546 | Poland |
| DERMED Centrum Medyczne Sp. z o.o. | Lodz | Łódź Voivodeship | 90-265 | Poland |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [Barcelona] | 08950 | Spain |
| Hospital Universitario de Gran Canaria Doctor Negrín | Las | Las Palmas | 35010 | Spain |
| Grupo Pedro Jaén | Madrid | Madrid | 28006 | Spain |
| Hospital Infantil Universitario Niño Jesús | Madrid | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Clinica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| CHOP-Centro De Especialidades De Mollabao | Pontevedra | Pontevedra [Pontevedra] | 36001 | Spain |
| Hospital de Manises | Manises | València | 46940 | Spain |
| National Taiwan University Hospital - Hsinchu branch | Hsinchu | Hsinchu | 300 | Taiwan |
| Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist | Kaohsiung | 83301 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | Taichung | 402 | Taiwan |
| National Taiwan University Hospital | Taipei | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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