Seeking adults aged 18 years to 70 years with a clinical diagnosis of atopic dermatitis (AD), with AD-involved body surface area (BSA) ≥ 10% at (roughly the size of 10 palm prints or more).Inclusion criteria include having moderate-to-severe AD.
Participants will receive either treatment via a subcutaneous injection (SC) or placebo Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.
Markham - Lynderm Research Inc.
The following information is from ClinicalTrials.gov
Last Update Posted: September 24, 2023
NCT05911841
Eli Lilly and Company
Brief Summary:
The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).
Condition or Disease:
Atopic Dermatitis
Intervention/Treatment:
Drug: LY3454738Phase:
Phase 2
Ages Eligible for Study:
18 Years and 70 Years (Adult)
Sexes Eligible for Study:
All
Inclusion Criteria:
Are candidates for systemic therapy.
ISA specific:
Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:
EASI score greater than or equal to (≥)16
vIGA-AD score ≥3, and
≥10% of BSA involvement (per EASI BSA).
Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.
Exclusion Criteria:
ISA specific:
Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
Are currently being treated with topical or systemic therapy
Recent treatment with experimental (biologics and/or small molecules) – doesn’t apply for subset of participants who must have been exposed to biologics and/or small molecules.
Terms and Conditions – ClinicalTrials.gov
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