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

Фаза 2 Завершено NCT04921345

Заболевание	Moderate-to-Severe Atopic Dermatitis
Фаза	Фаза 2
Спонсор	Galderma R&D
Статус	Завершено
Участники	109 участн.
Вмешательство	Nemolizumab, Nemolizumab
Дата начала	24.06.2021
Дата завершения	28.04.2025
Публикация результатов	26.05.2026

Кратко

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)
Cohort 1.1: Participants Aged 7-11 Years	2900 ± 893 nanograms per milliliters (ng/mL)
Cohort 2: Participants Aged 2-6 Years	3080 ± 1220 nanograms per milliliters (ng/mL)
Cohort 1: Participants Aged 7-11 Year	5150 ± 2150 nanograms per milliliters (ng/mL)
Cohort 1.1: Participants Aged 7-11 Years	2800 ± 986 nanograms per milliliters (ng/mL)
Cohort 2: Participants Aged 2-6 Years	2560 ± 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 Year	0.139 ± 0.0824 liter per day (L/day)
Cohort 1.1: Participants Aged 7-11 Years	0.134 ± 0.0407 liter per day (L/day)
Cohort 2: Participants Aged 2-6 Years	0.0761 ± 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 Year	3.39 ± 1.36 liter
Cohort 1.1: Participants Aged 7-11 Years	3.37 ± 1.02 liter
Cohort 2: Participants Aged 2-6 Years	1.75 ± 0.495 liter

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Другие исследования по этому заболеванию

A 32-week Trial to Evaluate the Efficacy and Safety of Tralokinumab in Subjects With Moder — LEO Pharma
A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis — Eli Lilly and Company
Aquacel Hypersensitivity Dressing in TJAs — Rush University Medical Center
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Par — Amgen
A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) — Amgen
A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic D — Amgen

Все исследования

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