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Completed
NCT04921345
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
Conditions: Moderate-to-Severe Atopic Dermatitis
Sex: All
Ages: 2 Years – 12 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 109
Sponsor: Galderma R&D
Location: Galderma Investigational Site #8636 Fountain Valley California
Summary
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).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT04921345). StuddyBuddy aggregates publicly available trial information.