Actively Recruiting
Phase 3 Study of Dupilumab Injection to Evaluate Safety and How the Drug Works in Children 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.
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
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