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

NCT04921345 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-07-18

No results posted yet for this study

Summary

The purpose of this study is to assess the pharmacokinetics (PK), efficacy, and safety of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).

Conditions

Interventions

DRUG

Nemolizumab

Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.

DRUG

Nemolizumab

Participants will receive SC injection of 5, 10 or 15 mg nemolizumab, Q4W for 52 weeks with a loading dose of 10, 20 or 30 mg at Day 1 based on the body weight.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2025-04-28
Completion
2025-04-28
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Hungary
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04921345 on ClinicalTrials.gov