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
- Registration Number
- NCT05735483
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 250
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lebrikizumab Placebo Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. Lebrikizumab Lebrikizumab 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) Lebrikizumab During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.
- Primary Outcome Measures
Name Time Method Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) Baseline through Week 52
- Secondary Outcome Measures
Name Time Method 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 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 EASI Baseline, 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 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 Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA) Baseline, 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 Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD) Baseline, Week 52 Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI Baseline, Week 52
Trial Locations
- Locations (94)
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
UConn Health
🇺🇸Farmington, Connecticut, United States
Allergy and Asthma Specialist
🇺🇸Owensboro, Kentucky, United States
Eukarya PharmaSite
🇲🇽Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, Mexico
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Integrative Skin Science and Research - Location 2
🇺🇸Sacramento, California, United States
Arkansas Research Trials
🇺🇸North Little Rock, Arkansas, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Solutions Through Advanced Research
🇺🇸Jacksonville, Florida, United States
Respiratory Medicine Research Institute of Michigan, PLC
🇺🇸Ypsilanti, Michigan, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Wright State Physicians
🇺🇸Fairborn, Ohio, United States
The University of Texas Health Science Center at Houston
🇺🇸Bellaire, Texas, United States
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, Argentina
Fundacion Cidea
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
CONEXA Investigacion Clinica S.A.
🇦🇷Buenos Aires, Argentina
Fundación Respirar
🇦🇷Buenos Aires, Argentina
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, Australia
Cornerstone Dermatology
🇦🇺Coorparoo, Queensland, Australia
Fundação Pio XII - Hospital de Câncer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
Pesquisare Saude
🇧🇷Santo André, São Paulo, Brazil
Hospital de Clínicas de Ribeirão Preto
🇧🇷Ribeirão Preto, São Paulo, Brazil
Clinica de Alergia Martti Antila
🇧🇷Sorocaba, São Paulo, Brazil
Faculdade de Medicina do ABC
🇧🇷Santo Andre, São Paulo, Brazil
Dermatology Research Institute
🇨🇦Calgary, Alberta, Canada
IBPClin - Instituto Brasil de Pesquisa Clínica
🇧🇷Rio de Janeiro, Brazil
Detska nemocnice FN Brno
🇨🇿Brno, Brno-město, Czechia
Fakultni nemocnice Bulovka
🇨🇿Prague, Praha 8, Czechia
Hôpitaux Drôme Nord - Romans
🇫🇷Romans-sur-Isère, Drôme, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
🇫🇷Nantes, Loire-Atlantique, France
CHU de Toulouse - Hopital Larrey
🇫🇷Toulouse, Midi-Pyrénées, France
Hôpital Saint Vincent-de-Paul
🇫🇷Lille, Nord-Pas-de-Calais, France
Rosenpark Research GmbH
🇩🇪Darmstadt, Hessen, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Hessen, Germany
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Niedersach, Germany
Universitätsklinikum Münster
🇩🇪Münster, Nordrhein-Westfalen, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Sachsen, Germany
Fujita Health University
🇯🇵Toyoake, Aichi, Japan
Fukuyama City Hospital
🇯🇵Fukuyama, Hiroshima, Japan
Asahikawa Medical College Hospital
🇯🇵Asahikawa, Hokkaido, Japan
National Hospital Organization Sagamihara National Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Osaka Habikino Medical Center
🇯🇵Habikino, Osaka, Japan
Dermatology and Ophthalmology Kume Clinic
🇯🇵Sakai City, Osaka, Japan
Enomoto Clinic
🇯🇵Kumagaya, Saitama, Japan
Ina Central Hospital
🇯🇵Ina, Nagano, Japan
Sugamo Sengoku Dermatology
🇯🇵Toshima, Tokyo, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Instituto Dermatologico de Jalisco
🇲🇽Zapopan, Jalisco, Mexico
PanAmerican Clinical Research - Cuernavaca
🇲🇽Cuernavaca, Morelos, Mexico
Trials in Medicine
🇲🇽Mexico City, Distrito Federal, Mexico
Hospital Infantil de Mexico Federico Gomez
🇲🇽Mexico City, Distrito Federal, Mexico
University Hospital,Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Okayama City General Medical Center Okayama City Hospital
🇯🇵Okayama, Japan
Hospital de Jesús Nazareno
🇲🇽Mexico City, Distrito Federal, Mexico
Scientia Investigacion Clinica S.C.
🇲🇽Chihuahua, Mexico
Arké SMO S.A de C.V
🇲🇽Veracruz, Mexico
Centrum Medyczne Evimed
🇵🇱Warsaw, Mazowieckie, Poland
Diamond Clinic
🇵🇱Krakow, Małopolski, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
DERMED Centrum Medyczne Sp. z o.o.
🇵🇱Lodz, Łódzkie, Poland
Hospital Sant Joan de Déu
🇪🇸Esplugues de Llobregat, Barcelona [Barcelona], Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las, Las Palmas, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Grupo Pedro Jaén
🇪🇸Madrid, Spain
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
CHOP-Centro De Especialidades De Mollabao
🇪🇸Pontevedra, Pontevedra [Pontevedra], Spain
Hospital de Manises
🇪🇸Manises, València, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
National Taiwan University Hospital - Hsinchu branch
🇨🇳Hsinchu, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Hospital Infantil Universitario Niño Jesús
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States