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 |
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| 相 | 第2相 |
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| スポンサー | Galderma R&D |
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| ステータス | 完了 |
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| 参加者数 | 109 名 |
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| 介入(薬剤) | Nemolizumab, Nemolizumab |
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| 開始日 | 2021年6月24日 |
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| 完了日 | 2025年4月28日 |
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| 結果公開日 | 2026年5月26日 |
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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 Year | 5950 ± 2240 nanograms per milliliters (ng/mL) |
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| Cohort 1.1: Participants Aged 7-11 Years | 2900 ± 893 nanograms per milliliters (ng/mL) |
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| Cohort 2: Participants Aged 2-6 Years | 3080 ± 1220 nanograms per milliliters (ng/mL) |
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| Cohort 1: Participants Aged 7-11 Year | 5150 ± 2150 nanograms per milliliters (ng/mL) |
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| Cohort 1.1: Participants Aged 7-11 Years | 2800 ± 986 nanograms per milliliters (ng/mL) |
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| Cohort 2: Participants Aged 2-6 Years | 2560 ± 1310 nanograms per milliliters (ng/mL) |
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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 Year | 0.139 ± 0.0824 liter per day (L/day) |
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| Cohort 1.1: Participants Aged 7-11 Years | 0.134 ± 0.0407 liter per day (L/day) |
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| Cohort 2: Participants Aged 2-6 Years | 0.0761 ± 0.0245 liter per day (L/day) |
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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 Year | 3.39 ± 1.36 liter |
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| Cohort 1.1: Participants Aged 7-11 Years | 3.37 ± 1.02 liter |
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| Cohort 2: Participants Aged 2-6 Years | 1.75 ± 0.495 liter |
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