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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05559359




Registration number
NCT05559359
Ethics application status
Date submitted
26/09/2022
Date registered
29/09/2022
Date last updated
28/05/2024

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

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
Topical corticosteroid
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 1
Secondary outcome [7] 0 0
Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM)
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 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.
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
15/06/2025
Actual
Sample size
Target
300
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 Pty Ltd - 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
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Connecticut
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Idaho
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Illinois
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Kentucky
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Massachusetts
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Michigan
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Wisconsin
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Buenos Aires
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Ciudad Autónoma De Buenos Aires
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Santa Fe
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Drôme
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France
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Hessen
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Veracruz
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Malopolskie
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Pomorskie
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Lódzkie
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Spain
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Barcelona [Barcelona]
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Las Palmas
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Madrid
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Pontevedra [Pontevedra]
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València
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Kaohsiung
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Taichung
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Taipei
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Hsinchu
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Taiwan
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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
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05559359
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05559359