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
- Registration Number
- NCT05735483
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 310
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lebrikizumab Placebo Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. Lebrikizumab Lebrikizumab Participants will receive Lebrikizumab administered subcutaneously (SC). Placebo will be administered to maintain the blind of parent study J2T-MC-KGBI. Lebrikizumab - Optional Extension Period (OEP) Lebrikizumab During the OEP, participants will be assigned to dose and treatment group based on participant weight and response achieved at treatment week-52.
- Primary Outcome Measures
Name Time Method Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) Baseline through Week 52
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (94)
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Arkansas Research Trials
🇺🇸North Little Rock, Arkansas, United States
First OC Dermatology
🇺🇸Fountain Valley, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Integrative Skin Science and Research - Location 2
🇺🇸Sacramento, California, United States
UConn Health
🇺🇸Farmington, Connecticut, United States
Solutions Through Advanced Research
🇺🇸Jacksonville, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
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