A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis, Eczema
- Registration Number
- JPRN-jRCT2031220533
- Lead Sponsor
- Masaki Takeshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Have a diagnosis of AD prior to screening as stated in the criteria by the American
Academy of Dermatology for at least:
-12 months s if participants are >=6 years of age, and
-6 months if participants are 6 months to <6 years of age
Have an EASI score >=16 at the screening and baseline
Have an IGA score >=3 (scale of 0 to 4) at the screening and baseline
Have >=10% BSA of AD involvement at the screening and baseline.
-Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study.
-Treatment with the following prior to the baseline:
-An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer.
-Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to <20%.
-Treatment with a topical investigational drug within 2 weeks prior to the baseline.
-Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction >=2 points from Baseline [ Time Frame: Baseline to Week 16 ]<br>-Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >=75% Reduction from Baseline in EASI Score [ Time Frame: Baseline to Week 16 ]
- Secondary Outcome Measures
Name Time Method