Guntersville,
Alabama
35976
Purpose:
The main purpose of the study is to assess the efficacy and safety of nemolizumab after a
16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic
dermatitis (AD) not adequately controlled with topical treatments.
Study summary:
This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in
adult and adolescent subjects of age 12 years and above with moderate-to-severe AD. Eligible
subjects must have a documented history of inadequate response to topical AD medication(s).
Approximately 750 subjects will be randomized in 2:1 to receive either nemolizumab or
placebo, stratified by baseline disease severity (Investigator's Global Assessment (IGA) = 3,
moderate; IGA = 4, severe) and peak pruritus numeric rating scale (PP NRS) severity (PP NRS =
7; PP NRS < 7).
Criteria:
Key Inclusion Criteria:
- Male or female subjects aged ≥ 12 years at the screening visit Note: Enrollment of
subjects aged 12 to 17 years has been opened after the IDMC has assessed interim
safety data from the phase 2 study (Protocol 116912) and provided recommendations to
the sponsor, who then determined 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
- PPNRS score of at least 4.0 at the screening and baseline visit
- Documented recent history of inadequate response to topical medications (TCS with or
without TCI)
- Female subjects of childbearing potential (that is, fertile, following menarche and
until becoming postmenopausal unless permanently sterile) must agree either to be
strictly abstinent throughout the study and for 12 weeks after the last study drug
injection, or to use an adequate 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 before the baseline visit, any infection requiring
treatment with oral or parenteral antibiotics, antivirals, antiparasitics or
antifungals within 2 weeks before the baseline visit, or any confirmed or suspected
coronavirus disease (COVID)-19 infection within 2 weeks before the screening or
baseline visit Note: Subjects with chronic, stable use of prophylactic treatment for
recurrent herpes viral infection can be included in this clinical study
- History of hypersensitivity (including anaphylaxis) to an immunoglobulin product
(plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug
excipients
- Any clinically significant issue, based on investigator judgement