A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
Study on Investigational Treatment for Prurigo Nodularis (a Skin Condition with Itchy Bumps) in Children and Adolescents
Study Overview
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.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Prurigo Nodularis
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Age: 6 months - 17 years
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Gender: All
Inclusion Criteria:
- Participants must be ≥6 months to <18 years of age, at the time of signing the informed consent.
- A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline.
- On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to <18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged ≥6 months to <6 years at the screening visit) ranging from 0 to 10, participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1.
NOTE: Baseline pruritus NRS average score for maximum itch intensity will be determined based on the average of daily NRS scores for maximum intensity (the daily score ranges from 0 to 10) during the 7 days immediately preceding the Day 1/Baseline visit. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. - Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study. - Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: - Presence of active moderate to severe lesions of atopic dermatitis (AD), and/or other skin conditions that may interfere with the PN diagnosis including but not limited to the following: scabies, psoriasis, lymphomatoid papulosis, habitual picking, dermatitis herpetiformis, sporotrichosis, and bullous disease. - Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period. NOTE: Participants may be rescreened after infection resolves. - Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator. - Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. - Planned or anticipated major surgical procedure during the participant's participation in this clinical trial. - Participants who has taken biologic therapy/systemic immunosuppressant/ immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer. - Current participation to any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or 5 half-lives of the investigational compound, whichever is longer. - Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
This study investigates prurigo nodularis, a skin condition characterized by itchy bumps. The purpose of the study is to understand how the investigational medication affects children and adolescents with this condition. Prurigo nodularis can cause intense itching and discomfort, and this study aims to explore potential treatment options for managing these symptoms.
Participants in this study will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will involve regular assessments of the skin condition and symptoms using scales to measure itchiness and other factors. Participants will also need to complete a daily symptom e-Diary to record their experiences.
- Who can participate: Children and adolescents between 6 months and 18 years old with prurigo nodularis can participate. They must have had the condition for at least 3 months and exhibit a certain level of itchiness. Participants must also be willing to complete a daily symptom diary.
- Study details: Participants will take part in the study by receiving either the investigational medication or a placebo. They will need to attend regular assessments and complete a daily symptom e-Diary. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study Timelines and Visits: The study will last 42 to 44 weeks. The study requires 6 visits.