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Enrolling by Invitation

NCT Number: NCT05735483

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

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis.

This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.

Enrolling by Invitation

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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–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Received treatment in Study KGBI and have adequately completed the study treatments and last visit of study KGBI, including any applicable systemic AD treatment washout.
  • 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

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.

Treatment and study plan

Lebrikizumab

Drug

Administered SC

Other names: LY3650150

Placebo

Drug

Administered SC

Primary outcomes

  1. Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)

    Time frame: Baseline through Week 52

Secondary outcomes

  1. 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

    Time frame: Baseline to Week 52

  2. 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

    Time frame: Baseline to Week 52

  3. Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ

    Time frame: Baseline to Week 52

  4. 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

    Time frame: Baseline to Week 52

  5. Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score

    Time frame: Baseline, Week 52

  6. Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)

    Time frame: Baseline, Week 52

  7. Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI

    Time frame: Baseline, Week 52

  8. Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI

    Time frame: Baseline, Week 52

  9. Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)

    Time frame: Baseline, Week 52

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: ADorable-2

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Feb 21, 2023
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.

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