BENITIONSClinical Trial Intelligence

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

第2相 完了 NCT04921345

対象疾患Moderate-to-Severe Atopic Dermatitis
第2相
スポンサーGalderma R&D
ステータス完了
参加者数109 名
介入(薬剤)Nemolizumab, Nemolizumab
開始日2021年6月24日
完了日2025年4月28日
結果公開日2026年5月26日

概要

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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