A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics, Safety and Efficacy of Nemolizumab (CD14152) in Pediatric Subjects (Aged 2 to 11 Years) With Moderate-to-Severe Atopic Dermatitis

RD.06.SPR.118126

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).

2021-06-24

2025-01-01

2025-07-01

Recruiting

Early phase I

105

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 105, 'type': 'ESTIMATED'}}

2023-04-07