Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05559359

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CONEXA Investigacion Clinica S.A., Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Lebrikizumab

Drug

Administered SC

Other names: LY3650150, DRM06

Placebo

Drug

Placebo given SC

Topical Corticosteroid (TCS)

Drug

TCS administered

Primary outcomes

  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

    EASI-75 is a co-primary endpoint with IGA.

  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

    IGA is a co-primary endpoint with EASI-75.

Secondary outcomes

  1. Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score

    Time frame: Baseline to Week 16

  2. 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

  3. Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16

    Time frame: Baseline to Week 16

  4. Percentage Change from Baseline in EASI Score

    Time frame: Baseline, Week 16

  5. Percentage Change from Baseline in Pruritus NRS Score

    Time frame: Baseline, Week 16

  6. Change from Baseline in Children Dermatology Life Quality Index (cDLQI)

    Time frame: Baseline, Week 16

  7. Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)

    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

  13. Percentage of Participants with a Worst Scratching/Itching NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline to Week 16

    Time frame: Baseline to Week 16

  14. Change from Baseline in SCORAD

    Time frame: Baseline, Week 16

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Dermira, Inc.

Registry information

Official study 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

Acronym: ADorable-1

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 29, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.