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 — BIOLOGICALParticipants 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: NemolizumabNemolizumab
Primary Outcome Measure
Nemolizumab Serum Concentrations at Week 1-2 [ Time Frame: At week 1-2 ]
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Galderma Investigational Site | Fountain Valley | California | 92708 | - |
| Galderma Investigational Site | Fremont | California | 94538 | - |
| Galderma Investigational Site | Jacksonville | Florida | 32256 | - |
| Galderma Investigational Site | Tampa | Florida | 33607 | - |
| Galderma Investigational Site | Columbus | Georgia | 31904 | - |
| Galderma Investigational Site | Sandy Springs | Georgia | 30128 | - |
| Galderma Investigational Site | Gresham | Oregon | 97030 | - |
| Galderma Investigational Site | Dallas | Texas | 75230-5806 | - |
| Galderma Investigational Site | Frisco | Texas | 75034 | - |
| Galderma Investigational Site | Richmond | Virginia | 23220 | - |
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