A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab

  • STATUS
    Recruiting
  • End date
    Jan 27, 2022
  • participants needed
    200
  • sponsor
    Galderma R&D
Updated on 27 January 2021
vaccination
atopy
nemolizumab

Summary

The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).

Description

This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent subjects ( 12 to 54 years) with moderate-to-severe AD. Eligible subjects must have a documented history of inadequate response to topical AD medication(s). Approximately 200 subjects will be randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity (IGA = 3, moderate; IGA = 4, severe). The study consists of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).

Details
Condition ATOPIC DERMATITIS, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Eczéma (Dermatite Atopique), Dermatite Atopique
Treatment Placebo, Nemolizumab
Clinical Study IdentifierNCT04365387
SponsorGalderma R&D
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Chronic AD for at least 2 years
EASI score >= 16
IGA score >= 3
AD involvement >= 10% of BSA
Peak (maximum) pruritus NRS score of at least 4.0

Exclusion Criteria

Body weight < 30 kilogram (kg)
History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
Participants for whom administration of the meningococcal vaccine provided in this study is contraindicated or medically inadvisable
Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable
Receipt of any vaccine (except inactivated influenza vaccine) within 12 weeks prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
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