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

• Status: Recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galderma R&D

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