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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 (ADorable-2)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Atopic Dermatitis
Eczema

Treatments

Drug: Lebrikizumab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05735483
2022-501478-21-00 (Other Identifier)
J2T-MC-KGBJ/DRM06-AD16 (Other Identifier)
18266

Details and patient eligibility

About

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

Enrollment

250 estimated patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

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

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

250 participants in 1 patient group

Lebrikizumab + Placebo
Experimental group
Description:
Lebrikizumab will be given subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.
Treatment:
Drug: Placebo
Drug: Lebrikizumab

Trial contacts and locations

96

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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