Atopic Dermatitis, Eczema
Conditions
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.
Interventions
DRUGLebrikizumab
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
All participants receive Lebrikizumab during the 16-week blinded treatment period. At Week 18, participants receive open-label lebrikizumab. From Week 52 onward, doses may be blinded or open-label.
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Discontinued From Study Treatment due to Adverse Events (AEs) | Baseline through Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| 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 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 Achieving EASI-90 (≥90% 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 |
| 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 SCORing Atopic Dermatitis (SCORAD) | Baseline, Week 52 |
| Percentage Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI | Baseline, Week 52 |
| Change from Baseline of Study KGBI by Visit in Study KGBJ in EASI | Baseline, Week 52 |
| Change from Baseline of Study KGBI by Visit in Study KGBJ in Body Surface Area (BSA) | Baseline, Week 52 |
Countries
Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Japan, Mexico, Poland, Spain, Taiwan, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed