Status:
COMPLETED
A Study to Assess Immunization Responses in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
Lead Sponsor:
Galderma R&D
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
12-54 years
Phase:
PHASE2
Brief 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-se...
Detailed Description
This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent participants (≥ 12 to 54 years) with moderate-to-severe AD. Eligible participants mus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2023
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04365387
Start Date
March 5 2020
End Date
July 7 2023
Last Update
June 5 2025
Active Locations (64)
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1
Galderma Investigational Site (Site#9922)
Phoenix, Arizona, United States, 85018
2
Galderma Investigational Site (Site#8873)
Scottsdale, Arizona, United States, 85260
3
Galderma Investigational Site (Site#8447)
Fort Smith, Arkansas, United States, 72916
4
Galderma Investigational Site (Site#8831)
Anaheim, California, United States, 92801