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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dermatitis, Atopic

In brief

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).

Key facts

Study ID

NCT04365387

Run by

Galderma R&D

People needed

242

Starts

2020-03-05

Expected to finish

2023-07-07

Last updated by the study team

2026-06-01

Who can join

Age: 12 and older, up to 54. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Galderma Investigational Site (Site#8873) — Scottsdale, Arizona, United States
• Galderma Investigational Site (Site#8447) — Fort Smith, Arkansas, United States
• Galderma Investigational Site (Site#8831) — Anaheim, California, United States
• Galderma Investigational Site (Site#8854) — Canoga Park, California, United States
• Galderma Investigational Site (Site#8578) — Cerritos, California, United States
• Galderma Investigational Site (Site#8791) — Fresno, California, United States
• Galderma Investigational Site (Site#8845) — Huntington Beach, California, United States
• Galderma Investigational Site (Site#8833) — Inglewood, California, United States
• Galderma Investigational Site 2 (Site#8833) — Inglewood, California, United States
• Galderma Investigational Site (Site#8858) — Long Beach, California, United States
• Galderma Investigational Site (Site#8130) — Los Angeles, California, United States
• Galderma Investigational Site (Site#8813) — Los Angeles, California, United States
• Galderma Investigational Site (Site#8837) — Pomona, California, United States
• Galderma Investigational Site (SIte#8870) — Boca Raton, Florida, United States
• Galderma Investigational Site (Site#8786) — Clearwater, Florida, United States
• Galderma Investigational Site (Site#8792) — Doral, Florida, United States
• Galderma Investigational Site (Site#8391) — Hialeah, Florida, United States
• Galderma Investigational Site (Site#8836) — Jacksonville, Florida, United States
• Galderma Investigational Site (Site#8850) — Margate, Florida, United States
• Galderma Investigational Site (Site#8851) — Miami, Florida, United States
• Galderma Investigational Site (Site#9921) — Miami Lakes, Florida, United States
• Galderma Investigational Site (Site#8840) — Ocoee, Florida, United States
• Galderma Investigational Site (Site#8788) — Orlando, Florida, United States
• Galderma Investigational Site (Site#8213) — Ormond Beach, Florida, United States
• Galderma Investigational Site (Site#9922) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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