Actively Recruiting
A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants 6 Months to Under 18 Years With Prurigo Nodularis
Led by Sanofi · Updated on 2026-01-15
18
Participants Needed
14
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sanofi
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics and safety of Dupilumab in children and adolescents aged 6 months to less than 18 years with prurigo nodularis, a chronic skin condition characterized by itchy nodules. This Phase 3, multicenter, open-label study aims to better understand how Dupilumab behaves in the body and its safety profile in this young population. Participants will receive Dupilumab administered by subcutaneous injection, with dosing based on their weight and age. The study includes three periods: a screening period lasting 2 to 4 weeks, a treatment period of 24 weeks during which Dupilumab is given, and a post-intervention follow-up period of 16 weeks. Each participant will have a total of 6 planned study visits over approximately 42 to 44 weeks. Throughout the study, participants will complete daily symptom diaries and undergo evaluations to measure Dupilumab concentration in the blood from Day 1 to Week 40. The study will also monitor any treatment-emergent or serious adverse events and check for the development of antibodies against Dupilumab. Safety and effectiveness assessments will continue during the follow-up period to ensure comprehensive monitoring of participant health and treatment response.
CONDITIONS
Brief 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 less than 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 with at least 6 itchy nodules.
- Lesions must be on 2 or more different body areas at baseline.
- Average worst itch score of 7 or higher on a 0 to 10 scale in the 7 days prior to Day 1.
- Willingness and ability to complete a daily symptom electronic diary.
- Male and female participants must use contraception according to local regulations if applicable.
You will not qualify if you...
- Presence of active moderate to severe atopic dermatitis or other skin conditions that interfere with prurigo nodularis diagnosis.
- Active infection needing systemic antibiotics, antivirals, or antifungals within 2 weeks before screening or during screening.
- Known or suspected immunodeficiency or history of serious opportunistic infections.
- Severe illnesses that may affect participation.
- Planned major surgery during the trial.
- Use of biologic therapy, systemic immunosuppressants, or immunomodulators within 4 weeks before screening.
- Participation in another investigational drug or device trial within 3 months before screening.
- Previous participation in a dupilumab clinical study or prior treatment with commercial dupilumab.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 weeks
Participants receive subcutaneous injections of Dupilumab based on weight and age to treat prurigo nodularis.
Regular visits during treatment for dosing and safety assessments
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)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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