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

Eli Lilly and Company94 sites in 8 countries310 target enrollmentMarch 9, 2023

ConditionsAtopic Dermatitis Eczema

InterventionsLebrikizumab Placebo

DrugsLebrikizumab Placebo

Overview

Phase: Phase 3
Intervention: Lebrikizumab
Conditions: Atopic Dermatitis
Sponsor: Eli Lilly and Company
Enrollment: 310
Locations: 94
Primary Endpoint: Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs)
Status: Enrolling By Invitation
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 9, 2023

End Date

April 1, 2029

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Lebrikizumab

Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.

Intervention: Lebrikizumab

Lebrikizumab

Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI.

Intervention: Placebo

Lebrikizumab - Optional Extension Period (OEP)

During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.

Intervention: Lebrikizumab

Outcomes

Primary Outcomes

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

Time Frame: Baseline through Week 52

Secondary Outcomes

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(Baseline to Week 52)
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in Pruritus NRS Score(Baseline, Week 52)
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI(Baseline, Week 52)
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(Baseline to Week 52)
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(Baseline to Week 52)
Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA)(Baseline, Week 52)
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline of Study KGBI by Visit in Study KGBJ(Baseline to Week 52)
Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in SCORing Atopic Dermatitis (SCORAD)(Baseline, Week 52)
Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI(Baseline, Week 52)