Actively Recruiting
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Led by Sanofi · Updated on 2026-01-15
18
Participants Needed
14
Research Sites
181 weeks
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 6 months to under 18 years old at consent.
- Clinical diagnosis of prurigo nodularis for at least 3 months before screening.
- Investigator’s global assessment score of 2 or higher for prurigo nodularis stage.
- Presence of 6 or more itchy nodules on 2 or more different body areas at baseline.
- Average worst itch score of 7 or more on a 0-10 scale in the 7 days before Day 1.
- Willingness and ability to complete a daily symptom electronic diary throughout the study.
- Use of contraception consistent with local regulations for male and female participants.
You will not qualify if you...
- Active moderate to severe atopic dermatitis or other skin conditions interfering with prurigo nodularis diagnosis.
- Active chronic or acute infection requiring systemic antibiotic, antiviral, or antifungal treatment within 2 weeks before screening or during screening.
- Known or suspected immunodeficiency or history of invasive opportunistic infections.
- Severe illnesses that might affect participation, as judged by the investigator.
- Planned major surgery during the study period.
- Use of biologic therapy, systemic immunosuppressants, or immunomodulators within 4 weeks before screening or 5 half-lives.
- Current or recent (within 3 months or 5 half-lives) participation in another investigational drug or device trial.
- Prior participation in dupilumab clinical studies or treatment with commercially available dupilumab.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021
Palo Alto, California, United States, 94304
Actively Recruiting
2
Mission Dermatology Center- Site Number : 8400011
Rancho Santa Margarita, California, United States, 92688
Actively Recruiting
3
Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005
Coral Gables, Florida, United States, 33146
Actively Recruiting
4
Life Clinical Trials - Coral Springs- Site Number : 8400018
Coral Springs, Florida, United States, 33071
Actively Recruiting
5
Direct Helpers Research Center- Site Number : 8400015
Hialeah, Florida, United States, 33012
Actively Recruiting
6
SunCoast Skin Solutions - Lutz- Site Number : 8400008
Lutz, Florida, United States, 33558
Actively Recruiting
7
USF Health- Site Number : 8400003
Tampa, Florida, United States, 33606
Actively Recruiting
8
Tareen Dermatology - Eagan- Site Number : 8400022
Eagan, Minnesota, United States, 55123
Actively Recruiting
9
MediSearch Clinical Trials- Site Number : 8400004
Saint Joseph, Missouri, United States, 64506
Actively Recruiting
10
AXIS Clinicals - Fargo- Site Number : 8400013
Fargo, North Dakota, United States, 58103
Actively Recruiting
11
Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
12
Dell Children's Medical Center- Site Number : 8400007
Austin, Texas, United States, 78723
Actively Recruiting
13
Driscoll Children's Hospital- Site Number : 8400017
Corpus Christi, Texas, United States, 78411
Actively Recruiting
14
Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400020
San Antonio, Texas, United States, 78218
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here