A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
- Conditions
- Atopic DermatitisEczema
- Interventions
- Registration Number
- NCT05559359
- Lead Sponsor
- Eli Lilly and Company
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 360
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lebrikizumab (Cohort 1) Lebrikizumab Participants who are 6 years to \<18 years of age, 12 years to \<18 years of age who weigh \<40 kilogram (kg) or 6 years to \<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight. Lebrikizumab (Cohort 1) Topical Corticosteroid (TCS) Participants who are 6 years to \<18 years of age, 12 years to \<18 years of age who weigh \<40 kilogram (kg) or 6 years to \<12 years of age (may weigh ≥40 kg) will receive a loading dose and then subsequent doses by subcutaneous (SC) injections with a topical corticosteroid (TCS). Dosing will be based on weight. Lebrikizumab (Cohort 2) Lebrikizumab Participants who are 6 months to \<6 years of age, 2 years to \<6 years of age or 6 months to \<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight. Lebrikizumab (Cohort 2) Topical Corticosteroid (TCS) Participants who are 6 months to \<6 years of age, 2 years to \<6 years of age or 6 months to \<2 years of age will receive a loading dose of lebrikizumab and then subsequent doses by SC injections with a TCS. Dosing will be based on weight. Placebo Placebo Participants will receive placebo matching lebrikizumab by SC injections with a TCS. Placebo Topical Corticosteroid (TCS) Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score Baseline to Week 16 Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline Baseline to Week 16
- Secondary Outcome Measures
Name Time Method Percentage Change from Baseline in Pruritus NRS Score Baseline, Week 16 Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score Baseline to Week 16 Percentage Change from Baseline in EASI Score Baseline, Week 16 Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline Baseline to Week 16 Change from Baseline in Children Dermatology Life Quality Index (cDLQI) Baseline, Week 16 Change from Baseline in Body Surface Area (BSA) Baseline, Week 16 Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) Week 14 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 Baseline to Week 16 Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS) Baseline, Week 16 Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Baseline, Week 16 Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score Baseline to Week 16 Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration Week 14
Trial Locations
- Locations (99)
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Arkansas Research Trials
🇺🇸North Little Rock, Arkansas, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Antelope Valley Clinical Trials
🇺🇸Lancaster, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Integrative Skin Science and Research - Location 2
🇺🇸Sacramento, California, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Solutions Through Advanced Research
🇺🇸Jacksonville, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Allergy and Asthma Specialist
🇺🇸Owensboro, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Oakland Hills Dermatology
🇺🇸Auburn Hills, Michigan, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
The Derm Institute of West Michigan
🇺🇸Caledonia, Michigan, United States
Respiratory Medicine Research Institute of Michigan, PLC
🇺🇸Ypsilanti, Michigan, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Wright State Physicians
🇺🇸Fairborn, Ohio, United States
The Pennsylvania Centre for Dermatology, LLC
🇺🇸Exton, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
The University of Texas Health Science Center at Houston
🇺🇸Bellaire, Texas, United States
Texas Dermatology and Laser Specialists
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Instituto de Neumonología Y Dermatología
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Psoriahue
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundacion Cidea
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Fundacion Estudios Clinicos
🇦🇷Rosario, Santa Fe, 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
Cornerstone Dermatology
🇦🇺Coorparoo, Queensland, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
🇧🇷Barretos, São Paulo, Brazil
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
Hospital de Clínicas de Ribeirão Preto
🇧🇷Ribeirão Preto, São Paulo, 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, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
🇧🇷Rio de Janeiro, Brazil
Dermatology Research Institute
🇨🇦Calgary, Alberta, Canada
Alberta Dermasurgery Centre
🇨🇦Edmonton, Alberta, Canada
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
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
Rosenpark Research GmbH
🇩🇪Darmstadt, Hessen, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Hessen, Germany
Fachklinik Bad Bentheim
🇩🇪Bad Bentheim, Niedersachsen, 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
Ina Central Hospital
🇯🇵Ina, Nagano, Japan
Osaka Habikino Medical Center
🇯🇵Habikino, Osaka, Japan
Dermatology and Ophthalmology Kume Clinic
🇯🇵Sakai City, Osaka, Japan
Enomoto Clinic
🇯🇵Kumagaya, Saitama, Japan
Sugamo Sengoku Dermatology
🇯🇵Toshima, Tokyo, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
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
Trials in Medicine
🇲🇽Mexico City, Distrito Federal, Mexico
Hospital Infantil de Mexico Federico Gomez
🇲🇽Mexico City, Distrito Federal, Mexico
Instituto Dermatologico de Jalisco
🇲🇽Zapopan, Jalisco, Mexico
PanAmerican Clinical Research - Cuernavaca
🇲🇽Cuernavaca, Morelos, Mexico
Eukarya PharmaSite
🇲🇽Monterrey, Nuevo León, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
🇲🇽Monterrey, Nuevo León, 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, Małopolskie, 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
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
CHOP-Centro De Especialidades De Mollabao
🇪🇸Pontevedra, Pontevedra [Pontevedra], Spain
Hospital de Manises
🇪🇸Manises, València, 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
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 - Hsinchu branch
🇨🇳Hsinchu, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital-Taipei
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan