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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05735483




Registration number
NCT05735483
Ethics application status
Date submitted
10/02/2023
Date registered
21/02/2023

Titles & IDs
Public title
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
Scientific title
A Phase 3, Multicenter, Long-Term Extension Study to Assess the Safety and Efficacy of Lebrikizumab in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
J2T-MC-KGBJ/DRM06-AD16
Secondary ID [2] 0 0
18266
Universal Trial Number (UTN)
Trial acronym
ADorable-2
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

Experimental: Lebrikizumab - Participants will receive Lebrikizumab administered subcutaneously (SC).

Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.

Experimental: Lebrikizumab - Optional Extension Period (OEP) - During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.


Treatment: Drugs: Lebrikizumab
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
Timepoint [1] 0 0
Baseline through Week 52
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI
Timepoint [8] 0 0
Baseline, Week 52
Secondary outcome [9] 0 0
Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)
Timepoint [9] 0 0
Baseline, Week 52

Eligibility
Key inclusion criteria
* 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
Minimum age
6 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
9/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
26/06/2026
Actual
Sample size
Target
250
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
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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Illinois
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Kentucky
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Massachusetts
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Michigan
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New Hampshire
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Ohio
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South Carolina
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Texas
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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
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Rio Grande Do Sul
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Brazil
State/province [21] 0 0
São Paulo
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Brazil
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Rio de Janeiro
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Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
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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France
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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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France
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Nord-Pas-de-Calais
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Germany
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Hessen
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Germany
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Niedersach
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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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Japan
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Aichi
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Hiroshima
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Hokkaido
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Kanagawa
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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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Malopolski
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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]
Country [56] 0 0
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
State/province [59] 0 0
Pontevedra [Pontevedra]
Country [60] 0 0
Spain
State/province [60] 0 0
València
Country [61] 0 0
Taiwan
State/province [61] 0 0
Kaohsiung
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taichung
Country [63] 0 0
Taiwan
State/province [63] 0 0
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

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) or
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/NCT05735483