BENITIONSClinical Trial Intelligence

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

2상 완료 NCT04921345

대상 질환Moderate-to-Severe Atopic Dermatitis
임상 단계2상
스폰서Galderma R&D
상태완료
참여자 수109 명
중재(약물)Nemolizumab, Nemolizumab
시작일2021년 6월 24일
완료일2025년 4월 28일
결과 공개일2026년 5월 26일

요약

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).

Nemolizumab Serum Concentrations

At Weeks 4, 8, 12, 16, 32 and 52 · nanograms per milliliters (ng/mL)

Cohort 1: Participants Aged 7-11 Year5950 ± 2240 nanograms per milliliters (ng/mL)
Cohort 1.1: Participants Aged 7-11 Years2900 ± 893 nanograms per milliliters (ng/mL)
Cohort 2: Participants Aged 2-6 Years3080 ± 1220 nanograms per milliliters (ng/mL)
Cohort 1: Participants Aged 7-11 Year5150 ± 2150 nanograms per milliliters (ng/mL)
Cohort 1.1: Participants Aged 7-11 Years2800 ± 986 nanograms per milliliters (ng/mL)
Cohort 2: Participants Aged 2-6 Years2560 ± 1310 nanograms per milliliters (ng/mL)

Apparent Total Body Clearance (Cl/F) of Nemolizumab

Pre-dose at Weeks 4, 8, 12, 16, 32 and 52 · liter per day (L/day)

Cohort 1: Participants Aged 7-11 Year0.139 ± 0.0824 liter per day (L/day)
Cohort 1.1: Participants Aged 7-11 Years0.134 ± 0.0407 liter per day (L/day)
Cohort 2: Participants Aged 2-6 Years0.0761 ± 0.0245 liter per day (L/day)

Apparent Volume of Distribution (Vd/F) of Nemolizumab

Pre-dose at Weeks 4, 8, 12, 16, 32 and 52 · liter

Cohort 1: Participants Aged 7-11 Year3.39 ± 1.36 liter
Cohort 1.1: Participants Aged 7-11 Years3.37 ± 1.02 liter
Cohort 2: Participants Aged 2-6 Years1.75 ± 0.495 liter

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