CTIS2022-501476-25-00
Recruiting
Phase 1
J2T-MC-KGBI/DRM06-AD13: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis Eczema
- Sponsor
- Eli Lilly & Co.
- Enrollment
- 291
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have Atopic Dermatitis for at least 6 months if younger than 6 years old or 1 year if older than 6 years., 6 months to 6 years old and weigh over 6 kilograms., 12 to 18 years old and weigh less than 40 kilograms., A parent or legal guardian must be able to sign the consent document and follow to the guidelines of the study., And meet other additional conditions at the time of the first visit.
Exclusion Criteria
- •Have been in a similar study with a similar drug or received a forbidden treatment within the last 2 \- 8 weeks., Be pregnant or breastfeeding., Have had previous reaction to the study drug or the ointments or cremes used in this study., Have a severe or current infection that requires strong antibiotics., Have a history of or have a current disease, or type of illness that your doctor believes could affect your safety., Have an addiction to drugs or alcohol.
Outcomes
Primary Outcomes
Not specified
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