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

  • STATUS
    Recruiting
  • End date
    Jul 18, 2025
  • participants needed
    70
  • sponsor
    Galderma R&D
Updated on 18 October 2021

Summary

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

Details
Condition Moderate to Severe Atopic Dermatitis
Treatment Nemolizumab
Clinical Study IdentifierNCT04921345
SponsorGalderma R&D
Last Modified on18 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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