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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05559359




Registration number
NCT05559359
Ethics application status
Date submitted
26/09/2022
Date registered
29/09/2022

Titles & IDs
Public title
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Scientific 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
Secondary ID [1] 0 0
J2T-MC-KGBI
Secondary ID [2] 0 0
18265
Universal Trial Number (UTN)
Trial acronym
ADorable-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Eczema 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lebrikizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Topical Corticosteroid (TCS)

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.

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.

Placebo comparator: Placebo - Participants will receive placebo matching lebrikizumab by SC injections with a TCS.


Treatment: Drugs: Lebrikizumab
Administered SC

Treatment: Drugs: Placebo
Placebo given SC

Treatment: Drugs: Topical Corticosteroid (TCS)
TCS administered
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction =2 points from Baseline
Timepoint [1] 0 0
Baseline to Week 16
Primary outcome [2] 0 0
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) =75% Reduction from Baseline in EASI Score
Timepoint [2] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving EASI-90, a =90% Reduction from Baseline in EASI Score
Timepoint [1] 0 0
Baseline to Week 16
Secondary outcome [2] 0 0
Percentage Change from Baseline in EASI Score
Timepoint [2] 0 0
Baseline, Week 16
Secondary outcome [3] 0 0
Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of =4 points at Baseline Who Achieve a =4-point Reduction from Baseline
Timepoint [3] 0 0
Baseline to Week 16
Secondary outcome [4] 0 0
Percentage Change from Baseline in Pruritus NRS Score
Timepoint [4] 0 0
Baseline, Week 16
Secondary outcome [5] 0 0
Change from Baseline in Children Dermatology Life Quality Index (cDLQI)
Timepoint [5] 0 0
Baseline, Week 16
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline to Week 16
Secondary outcome [7] 0 0
Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)
Timepoint [7] 0 0
Baseline, Week 16
Secondary outcome [8] 0 0
Change from Baseline in Body Surface Area (BSA)
Timepoint [8] 0 0
Baseline, Week 16
Secondary outcome [9] 0 0
Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)
Timepoint [9] 0 0
Baseline, Week 16
Secondary outcome [10] 0 0
Percentage of Participants Achieving EASI-50, a =50% Reduction from Baseline in EASI Score
Timepoint [10] 0 0
Baseline to Week 16
Secondary outcome [11] 0 0
Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration
Timepoint [11] 0 0
Week 14
Secondary outcome [12] 0 0
Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
Timepoint [12] 0 0
Week 14

Eligibility
Key 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 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.
Minimum age
6 Months
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Cornerstone Dermatology - Coorparoo
Recruitment hospital [4] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4151 - Coorparoo
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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Connecticut
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Florida
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Idaho
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United States of America
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Illinois
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United States of America
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Kentucky
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United States of America
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Massachusetts
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United States of America
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Michigan
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New Hampshire
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Ohio
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Pennsylvania
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South Carolina
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Texas
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Argentina
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Santa Fe
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Brazil
State/province [21] 0 0
Rio Grande Do Sul
Country [22] 0 0
Brazil
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São Paulo
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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Canada
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Ontario
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Czechia
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Brno-mesto
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Czechia
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Praha 8
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Drôme
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France
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Loire-Atlantique
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France
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Midi-Pyrénées
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen
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Aichi
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Hokkaido
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Nagano
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Osaka
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Saitama
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Tokyo
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Japan
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Kyoto
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Japan
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Okayama
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Morelos
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Mexico
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Nuevo León
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Mexico
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Chihuahua
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Mexico
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Veracruz
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Poland
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Mazowieckie
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Poland
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Malopolskie
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Poland
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Pomorskie
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Poland
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Lódzkie
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Spain
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Barcelona [Barcelona]
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Spain
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Las Palmas
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Spain
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Madrid
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Spain
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Navarra
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Spain
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Pontevedra [Pontevedra]
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Spain
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València
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Hsinchu
Country [64] 0 0
Taiwan
State/province [64] 0 0
Taipei
Country [65] 0 0
Taiwan
State/province [65] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Dermira, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05559359