Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
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Layout table for eligibility information
Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Key Inclusion Criteria:
Male or female subjects aged ≥ 12 years at the screening visit
Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed interim safety data from the phase 2 study (Protocol 116912) and provided recommendations to the sponsor, who will then determine the eligibility of this age group for enrollment in the study.
Chronic AD that has been documented for at least 2 years
EASI score ≥ 16
IGA score ≥ 3
AD involvement ≥ 10% of BSA
Documented recent history of inadequate response to topical medications (TCS with or without TCI).
Female subjects of childbearing potential must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
Key Exclusion Criteria:
Body weight < 30 kg.
Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study
Cutaneous infection within 1 week or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week
History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
Any clinically significant issue, based investigator judgement