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ADorable-1: A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05559359
Collaborator
Dermira, Inc. (Industry)
300
Enrollment
95
Locations
3
Arms
33.9
Anticipated Duration (Months)
3.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Actual Study Start Date :
Oct 18, 2022
Anticipated Primary Completion Date :
Jul 15, 2024
Anticipated Study Completion Date :
Aug 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lebrikizumab (Cohort 1)

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.

Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150
  • DRM06

    • Drug: Topical corticosteroid
    Topical corticosteroid
    Experimental: Lebrikizumab (Cohort 2)

    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.

    Drug: Lebrikizumab
    Administered SC
    Other Names:
  • LY3650150
  • DRM06

    • Drug: Topical corticosteroid
    Topical corticosteroid
    Placebo Comparator: Placebo

    Participants will receive placebo matching lebrikizumab by SC injections with a TCS.

    Drug: Placebo
    Placebo given SC

    Drug: Topical corticosteroid
    Topical corticosteroid

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline [Baseline to Week 16]

    2. Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score [Baseline to Week 16]

    Secondary Outcome Measures

    1. Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score [Baseline to Week 16]

    2. Percentage Change from Baseline in EASI Score [Baseline, Week 16]

    3. 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]

    4. Percentage Change from Baseline in Pruritus NRS Score [Baseline, Week 16]

    5. Change from Baseline in Children Dermatology Life Quality Index (cDLQI) [Baseline, Week 16]

    6. 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 1]

    7. Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM) [Baseline, Week 16]

    8. Change from Baseline in Body Surface Area (BSA) [Baseline, Week 16]

    9. Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD) [Baseline, Week 16]

    10. Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score [Baseline to Week 16]

    11. Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration [Week 14]

    12. Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) [Week 14]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Have a diagnosis of AD prior to screening as stated in the criteria by the American
    Academy of Dermatology for at least:

    • 12 months s if participants are ≥6 years of age, and

    • 6 months if participants are 6 months to <6 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of Alabama Birmingham Alabama United States 35209
    2 Phoenix Children's Hospital Phoenix Arizona United States 85016
    3 Arkansas Research Trials North Little Rock Arkansas United States 72217
    4 First OC Dermatology Fountain Valley California United States 92708
    5 Antelope Valley Clinical Trials Lancaster California United States 93534
    6 Dermatology Research Associates Los Angeles California United States 90045
    7 Integrative Skin Science and Research Sacramento California United States 95815
    8 UConn Health Farmington Connecticut United States 06030-2840
    9 Solutions Through Advanced Research Jacksonville Florida United States 32256
    10 ForCare Clinical Research Tampa Florida United States 33613-1244
    11 Treasure Valley Medical Research Boise Idaho United States 83706
    12 Northwestern University Chicago Illinois United States 60611
    13 Allergy and Asthma Specialist Owensboro Kentucky United States 42301
    14 Massachusetts General Hospital Boston Massachusetts United States 02114
    15 Oakland Hills Dermatology Auburn Hills Michigan United States 48326
    16 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
    17 The Derm Institute of West Michigan Caledonia Michigan United States 49316
    18 Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan United States 48197
    19 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03766
    20 Wright State Physicians Fairborn Ohio United States 45324
    21 The Pennsylvania Centre for Dermatology, LLC Exton Pennsylvania United States 19341
    22 Medical University of South Carolina Charleston South Carolina United States 29425
    23 The University of Texas Health Science Center at Houston Bellaire Texas United States 77401
    24 Texas Dermatology and Laser Specialists San Antonio Texas United States 78218
    25 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    26 Instituto de Neumonología Y Dermatología Ciudad Autonoma de Buenos Aire Buenos Aires Argentina C1425BEA
    27 Psoriahue Ciudad Autonoma de Buenos Aire Buenos Aires Argentina C1425DKG
    28 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aire Buenos Air Argentina 1027
    29 Fundacion Cidea Buenos Aires Ciudad Aut Argentina C1121ABE
    30 Fundacion Estudios Clinicos Rosario Santa Fe Argentina S2000DEJ
    31 CONEXA Investigacion Clinica S.A. Buenos Aires Argentina 1012
    32 Fundación Respirar Buenos Aires Argentina C1426ABP
    33 Sydney Children's Hospital Randwick New South Wales Australia 2031
    34 The Children's Hospital at Westmead Westmead New South Wales Australia 2145
    35 Veracity Clinical Research Woolloongabba Queensland Australia 4102
    36 Dermatology Research Institute Calgary Alberta Canada T2J 7E1
    37 Alberta Dermasurgery Centre Edmonton Alberta Canada T6G 1C3
    38 DermEdge Research Mississauga Ontario Canada L4Y 4C5
    39 Detska nemocnice FN Brno Brno Brno-město Czechia 613 00
    40 Fakultni nemocnice Hradec Kralove Hradec Kralove Hradec Králové Czechia 500 05
    41 PreventaMed Olomouc Olomoucký Kraj Czechia 779 00
    42 Nemocnice Na Bulovce Prague Praha 8 Czechia 180 81
    43 Fakultni nemocnice Kralovske Vinohrady Praha 10 Czechia 10034
    44 Hôpitaux Drôme Nord - Romans Romans-sur-Isère Drôme France 26102
    45 Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou Rennes Ille-et-Vilaine France 35033
    46 Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu Nantes Loire-Atlantique France 44093 Cede
    47 CHU de Toulouse - Hopital Larrey Toulouse Midi-Pyrénées France 31400
    48 Hôpital Saint Vincent-de-Paul Lille Nord-Pas-de-Calais France 59020
    49 Rosenpark Research GmbH Darmstadt Hessen Germany 64283
    50 Universitätsklinikum Frankfurt Frankfurt Hessen Germany 60590
    51 Fachklinik Bad Bentheim Bad Bentheim Niedersachsen Germany 48455
    52 Studienzentrum an der Hase Dr. Weyergraf/Dr. Frick/T. Heiber GbR Bramsche Niedersachsen Germany 49565
    53 Universitätsklinikum Münster Münster Nordrhein-Westfalen Germany 48149
    54 Universitaetsklinikum Carl Gustav Carus Dresden Dresden Sachsen Germany 01307
    55 Fujita Health University Toyoake Aichi Japan 470-1192
    56 Fukuyama City Hospital Fukuyama Hiroshima Japan 721-8511
    57 Asahikawa Medical College Hospital Asahikawa Hokkaido Japan 078-8510
    58 National Hospital Organization Sagamihara National Hospital Sagamihara Kanagawa Japan 252-0392
    59 Ina Central Hospital Ina Nagano Japan 396-0033
    60 Osaka Habikino Medical Center Habikino Osaka Japan 583-8588
    61 Dermatology and Ophthalmology Kume Clinic Sakai City Osaka Japan 593-8324
    62 Enomoto Clinic Kumagaya Saitama Japan 360-0018
    63 Sugamo Sengoku Dermatology Toshima Tokyo Japan 170-0002
    64 Hiroshima University Hospital Hiroshima Japan 734-8551
    65 Kyoto Furitsu Medical University Hospital Kyoto Japan 602-8566
    66 Okayama City General Medical Center Okayama City Hospital Okayama Japan 700-8557
    67 Hospital de Jesús Nazareno Mexico City Distrito Federal Mexico 06090
    68 Trials in Medicine Mexico City Distrito Federal Mexico 06700
    69 Hospital Infantil de Mexico Federico Gomez Mexico City Distrito Federal Mexico 06720
    70 PanAmerican Clinical Research - Cuernavaca Cuernavaca Morelos Mexico 62290
    71 Centro de Dermatologia de Monterrey Monterrey Nuevo León Mexico 64460
    72 Eukarya PharmaSite Monterrey Nuevo León Mexico 64718
    73 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
    74 Scientia Investigacion Clinica S.C. Chihuahua Mexico 31203
    75 Arké SMO S.A de C.V Veracruz Mexico 91910
    76 Centrum Medyczne Evimed Warsaw Mazowieckie Poland 02-625
    77 Diamond Clinic Krakow Małopolskie Poland 31-559
    78 Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie Poland 80-546
    79 "DERMED" Centrum Medyczne Sp. z o.o. Lodz Łódzkie Poland 90-265
    80 Hospital Sant Joan de Déu Esplugues de Llobregat Barcelona [Barcelona] Spain 08950
    81 Hospital Universitario de Gran Canaria Doctor Negrín Las Las Palmas Spain 35010
    82 Hospital Universitario Quironsalud Madrid Pozuelo de Alarcon Madrid Spain 28223
    83 Clinica Universidad de Navarra Pamplona Navarra Spain 31008
    84 Centro De Especialidades De Mollabao Pontevedra Pontevedra [Pontevedra] Spain 36001
    85 Hospital de Manises Manises València Spain 46940
    86 Hospital Infantil Universitario Niño Jesús Madrid Spain 28009
    87 Hospital Universitario 12 de Octubre Madrid Spain 28041
    88 Hospital Universitario La Paz Madrid Spain 28046
    89 Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao Sung Dist Kaohsiung Taiwan 83301
    90 Chung Shan Medical University Hospital Taichung City Taichung Taiwan 402
    91 Taipei Veterans General Hospital Taipei City Taipei Taiwan 112
    92 National Taiwan University Hospital - Hsinchu branch Hsinchu Taiwan 300
    93 National Taiwan University Hospital Taipei Taiwan 10002
    94 Chang Gung Memorial Hospital-Taipei Taipei Taiwan 105
    95 Chang Gung Medical Foundation-Linkou Branch Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Eli Lilly and Company
    • Dermira, Inc.

    Investigators

    • Study Director: 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), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05559359
    Other Study ID Numbers:
    • 18265
    • J2T-MC-KGBI
    • DRM06-AD13
    • 2021-005232-29
    First Posted:
    Sep 29, 2022
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dermatitis, Atopic
    Dermatitis
    Eczema

    Study Results

    No Results Posted as of Jan 18, 2023