This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05559359
Recruitment Status : Recruiting
First Posted : September 29, 2022
Last Update Posted : April 17, 2024
Sponsor:
Collaborator:
Dermira, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Atopic Dermatitis Eczema Drug: Lebrikizumab Drug: Placebo Drug: Topical corticosteroid Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 18, 2022
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : June 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline [ Time Frame: Baseline to Week 16 ]
  2. Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score [ Time Frame: Baseline to Week 16 ]
  2. Percentage Change from Baseline in EASI Score [ Time Frame: 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 [ Time Frame: Baseline to Week 16 ]
  4. Percentage Change from Baseline in Pruritus NRS Score [ Time Frame: Baseline, Week 16 ]
  5. Change from Baseline in Children Dermatology Life Quality Index (cDLQI) [ Time Frame: 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 [ Time Frame: Baseline to Week 1 ]
  7. Mean Change from Baseline in Parent-Reported Itch Severity Measure (PRISM) [ Time Frame: Baseline, Week 16 ]
  8. Change from Baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Week 16 ]
  9. Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD) [ Time Frame: Baseline, Week 16 ]
  10. Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score [ Time Frame: Baseline to Week 16 ]
  11. Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration [ Time Frame: Week 14 ]
  12. Percentage of Participants with Positive Responses by the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) [ Time Frame: Week 14 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05559359


Contacts
Layout table for location contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
Show Show 96 study locations
Sponsors and Collaborators
Eli Lilly and Company
Dermira, Inc.
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05559359    
Other Study ID Numbers: 18265
J2T-MC-KGBI ( Other Identifier: Eli Lilly and Company )
DRM06-AD13 ( Other Identifier: Dermira Inc )
2021-005232-29 ( EudraCT Number )
2022-501476-25-00 ( Other Identifier: EU Trial Number )
First Posted: September 29, 2022    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases