Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

Completed · Phase 2

Conditions studied: Moderate-to-Severe Atopic Dermatitis

In brief

The purpose of this study was to assess the pharmacokinetics (PK), safety, and efficacy of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Key facts

Study ID

NCT04921345

Run by

Galderma R&D

People needed

109

Starts

2021-06-24

Expected to finish

2025-04-28

Last updated by the study team

2026-06-25

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic AD that has been documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
• EASI score >=16 at both screening and baseline visits
• IGA score >=3 at both screening and baseline visits
• AD involvement >=10% of BSA at both screening and baseline visits
• Peak (maximum) PP NRS score of at least 4.0 at both screening and baseline visits
• Agree to apply a moisturizer throughout the study from the screening visit daily, and liberally as needed; agree to apply an authorized topical corticosteroids (TCS) from the screening visit and throughout the study as determined appropriate by the investigator
• Participant and caregiver willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol
• Other protocol defined inclusion criteria could apply

You may not qualify if…

• Body weight less than 10 kilogram (kg)
• Child in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
• Participants with a current medical history of chronic bronchitis
• Requiring rescue therapy for AD during the run-in period or expected to require rescue therapy within 2 weeks following the baseline visit
• Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), hepatitis C (HCV) antibody with positive confirmatory test for HCV (example; polymerase chain reaction [PCR]), or human immunodeficiency virus (HIV) antibody at the screening visit
• History of lymphoproliferative disease, hypersensitivity (including anaphylaxis) to an immunoglobulin product and intolerance to low or mid potency topical corticosteroids
• Known or suspected immunosuppression
• Participants unwilling to refrain from using prohibited medications during the clinical trial.
• Other protocol defined exclusion criteria could apply

Where it is running

• Galderma Investigational Site #8636 — Fountain Valley, California, United States
• Galderma Investigational Site #9937 — San Diego, California, United States
• Galderma Investigational Site #9930 — Vista, California, United States
• Galderma Investigational Site #9929 — Coral Gables, Florida, United States
• Galderma Investigational Site #8142 — Indianapolis, Indiana, United States
• Galderma Investigational Site #8092 — Louisville, Kentucky, United States
• Galderma Investigational Site #8155 — Troy, Michigan, United States
• Galderma Investigational Site #8560 — West Bloomfield, Michigan, United States
• Galderma Investigational Site #8242 — Brooklyn, New York, United States
• Galderma Investigational Site #9938 — New York, New York, United States
• Galderma Investigational Site #8206 — Norman, Oklahoma, United States
• Galderma Investigational Site #8255 — Philadelphia, Pennsylvania, United States
• Galderma Investigational Site #9931 — Beaumont, Texas, United States
• Galderma Investigational Site #78218-3128 — San Antonio, Texas, United States
• Galderma Investigational Site #6218 — Hellerup, Denmark
• Galderma Investigational Site #6147 — Budapest, Hungary
• Galderma Investigational Site #5531 — Szeged, Hungary
• Galderma Investigational Site #5570 — Lodz, Poland
• Galderma Investigational Site #6237 — Ostrowiec Świętokrzyski, Poland
• Galderma Investigational Site #5495 — Rzeszów, Poland
• Galderma Investigational Site #6262 — Warsaw, Poland
• Galderma Investigational Site #6261 — Wroclaw, Poland
• Galderma Investigational Site #5896 — Esplugues de Llobregat, Spain

Full record on ClinicalTrials.gov

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