A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis

Part of paid clinical trials in Palo Alto, California.

Sponsor
Sanofi
Study ID
NCT06293053
Phase
PHASE3
Status
Recruiting
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Conditions

  • Prurigo Nodularis

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Jan 2026
Primary completion
Oct 28, 2027
Completion
Nov 3, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab
    Administered subcutaneously (SC) based on weight and age

Primary Outcome Measure

Concentration of dupilumab in serum [ Time Frame: Day 1 to Week 40 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (14)

FacilityCityStateZIPSite coordinators
Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021Palo AltoCalifornia94304-
Mission Dermatology Center- Site Number : 8400011Rancho Santa MargaritaCalifornia92688-
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005Coral GablesFlorida33146-
Life Clinical Trials - Coral Springs- Site Number : 8400018Coral SpringsFlorida33071-
Direct Helpers Research Center- Site Number : 8400015HialeahFlorida33012-
SunCoast Skin Solutions - Lutz- Site Number : 8400008LutzFlorida33558-
USF Health- Site Number : 8400003TampaFlorida33606-
Tareen Dermatology - Eagan- Site Number : 8400022EaganMinnesota55123-
MediSearch Clinical Trials- Site Number : 8400004Saint JosephMissouri64506-
AXIS Clinicals - Fargo- Site Number : 8400013FargoNorth Dakota58103-
Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002TulsaOklahoma74136-
Dell Children's Medical Center- Site Number : 8400007AustinTexas78723-
Driscoll Children's Hospital- Site Number : 8400017Corpus ChristiTexas78411-
Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400020San AntonioTexas78218-

Find similar trials in Palo Alto, CA

By research site
Stanford University Medical Center CTRU - 800 Welch Road· Palo Alto, CAMission Dermatology Center· Rancho Santa Margarita, CAPediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology· Coral Gables, FLLife Clinical Trials - Coral Springs· Coral Springs, FLDirect Helpers Research Center· Hialeah, FLSunCoast Skin Solutions - Lutz· Lutz, FL

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