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

• Status: Recruiting
• Trial end date: 2022-01-27
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D

Criteria

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