Guntersville, Alabama 35976

  • Severe Atopic Dermatitis

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 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 - 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 - History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) - Any clinically significant issue, based on investigator judgement


NCT ID:

NCT03989349


Primary Contact:

Galderma Research & Development
Phone: 817-961-5000
Email: clinical.studies@galderma.com


Backup Contact:

Email: clinical.studies@galderma.com
Research & Development


Location Contact:

Guntersville, Alabama 35976
United States

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 15, 2021

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