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

• ClinicalTrials.gov Identifier: NCT05559359
• Recruitment Status: Recruiting
• First Posted: September 29, 2022
• Last Update Posted: April 17, 2024
• Sponsor: Eli Lilly and Company
• Collaborator: Dermira, Inc.
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: September 26, 2022
• First Posted Date: September 29, 2022
• Last Update Posted Date: April 17, 2024
• Actual Study Start Date: October 18, 2022
• Estimated Primary Completion Date: July 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2022)

• 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 ]
• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 26, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Atopic Dermatitis
• Eczema

Intervention

• Drug: Lebrikizumab
  Administered SC
  Other Names:

  • LY3650150
  • DRM06
• Drug: Placebo
  Placebo given SC
• Drug: Topical corticosteroid
  Topical corticosteroid

Study Arms

• 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.

  Interventions:

  • Drug: Lebrikizumab
  • Drug: 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.

  Interventions:

  • Drug: Lebrikizumab
  • Drug: Topical corticosteroid
• Placebo Comparator: Placebo
  Participants will receive placebo matching lebrikizumab by SC injections with a TCS.
  Interventions:

  • Drug: Placebo
  • Drug: Topical corticosteroid

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 26, 2022): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 15, 2025
• Estimated Primary Completion Date: July 15, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 17 Years (Child)
• Accepts Healthy Volunteers: No

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

• Listed Location Countries: Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Japan, Mexico, Poland, Spain, Taiwan, United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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/

• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: 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

• PRS Account: Eli Lilly and Company
• Verification Date: April 2024