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

Galderma

Status and phase: Enrolling; Phase 2

Conditions: Moderate-to-Severe Atopic Dermatitis

Treatments: Drug: Nemolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04921345

RD.06.SPR.118126

Details and patient eligibility

About

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).

Enrollment: 105 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Cohort 1: Participants aged 7-11 years

Experimental group

Description:

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Treatment:

Drug: Nemolizumab

Drug: Nemolizumab

Cohort 1.1: Participants aged 7-11 years

Experimental group

Description:

Participants aged 7-11 years will receive nemolizumab for 52 weeks.

Treatment:

Drug: Nemolizumab

Drug: Nemolizumab

Cohort 2: Participants aged 2-6 years

Experimental group

Description:

Participants aged 2-6 years will receive nemolizumab for 52 weeks.

Treatment:

Drug: Nemolizumab

Drug: Nemolizumab