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

Phase 2 Completed NCT04921345

Condition	Moderate-to-Severe Atopic Dermatitis
Phase	Phase 2
Sponsor	Galderma R&D
Status	Completed
Enrollment	109 participants
Interventions	Nemolizumab, Nemolizumab
Start date	Jun 24, 2021
Completion date	Apr 28, 2025
Results posted	May 26, 2026

Summary

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

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

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

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.

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