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Trials / Completed

CompletedNCT03921411

A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

A Multicenter, Open-Label, Single-Group Clinical Trial to Assess the Pharmacokinetics and Safety of Nemolizumab (CD14152) in Adolescent Subjects (12-17 Years) With Moderate-to-Severe Atopic Dermatitis

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Galderma R&D · Industry
Sex
All
Age
12 Years – 17 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study was to evaluate the pharmacokinetics and safety of nemolizumab in adolescent participants with AD.

Conditions

Interventions

TypeNameDescription
BIOLOGICALNemolizumabParticipants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.

Timeline

Start date
2019-04-09
Primary completion
2020-08-19
Completion
2020-08-19
First posted
2019-04-19
Last updated
2023-04-21
Results posted
2023-04-21

Locations

10 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03921411. Inclusion in this directory is not an endorsement.

A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD) (NCT03921411) · Clinical Trials Directory