This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: * Screening period: 2 to 4 weeks. * Treatment period: 24 weeks. * Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods). The total number of planned study visits for each participant will be 6.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021
Palo Alto, California, United States
RECRUITINGMission Dermatology Center- Site Number : 8400011
Rancho Santa Margarita, California, United States
RECRUITINGPediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005
Coral Gables, Florida, United States
RECRUITINGLife Clinical Trials - Coral Springs- Site Number : 8400018
Coral Springs, Florida, United States
RECRUITINGDirect Helpers Research Center- Site Number : 8400015
Hialeah, Florida, United States
RECRUITINGSunCoast Skin Solutions - Lutz- Site Number : 8400008
Lutz, Florida, United States
RECRUITINGUSF Health- Site Number : 8400003
Tampa, Florida, United States
RECRUITINGTareen Dermatology - Eagan- Site Number : 8400022
Eagan, Minnesota, United States
RECRUITINGMediSearch Clinical Trials- Site Number : 8400004
Saint Joseph, Missouri, United States
RECRUITINGAXIS Clinicals - Fargo- Site Number : 8400013
Fargo, North Dakota, United States
RECRUITING...and 4 more locations
Concentration of dupilumab in serum
Concentration of dupilumab in serum over time
Time frame: Day 1 to Week 40
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Time frame: Date of signed ICF (2-4 weeks before Day 1) to Week 40
Incidence of anti-drug antibodies (ADA) to dupilumab over time
Time frame: Day 1 to Week 40
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
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