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

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Galderma R&D
Study ID
NCT03921411
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Nemolizumab — BIOLOGICAL
    Participants 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.

Study Details

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

Key Dates

Start date
Apr 9, 2019
Status verified
Apr 2023
Primary completion
Aug 19, 2020
Completion
Aug 19, 2020

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nemolizumab
    Nemolizumab

Primary Outcome Measure

Nemolizumab Serum Concentrations at Week 1-2 [ Time Frame: At week 1-2 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Galderma Investigational SiteFountain ValleyCalifornia92708-
Galderma Investigational SiteFremontCalifornia94538-
Galderma Investigational SiteJacksonvilleFlorida32256-
Galderma Investigational SiteTampaFlorida33607-
Galderma Investigational SiteColumbusGeorgia31904-
Galderma Investigational SiteSandy SpringsGeorgia30128-
Galderma Investigational SiteGreshamOregon97030-
Galderma Investigational SiteDallasTexas75230-5806-
Galderma Investigational SiteFriscoTexas75034-
Galderma Investigational SiteRichmondVirginia23220-

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