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

Study of Investigational Medication for Itchy Skin Condition in Children and Adolescents

Recruiting
6 months - 17 years
All
Phase 3
18 participants needed
11 Locations

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
  • Age: 6 months - 17 years
  • 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.

Updated on 25 Mar 2025. Study ID: NCT06293053

This study investigates the use of an investigational medication for children and adolescents with prurigo nodularis, a skin condition characterized by itchy nodules. The purpose of the study is to assess the safety and how the body processes the medication in participants aged 6 months to less than 18 years.

Participants will be required to visit the study center for assessments and will need to complete a daily electronic diary to track symptoms. The study includes a screening period, a treatment period lasting 24 weeks, and a post-treatment follow-up period.

  • Who can participate: Children and adolescents aged 6 months to less than 18 years with a clinical diagnosis of prurigo nodularis for at least 3 months can participate. Key eligibility factors include having at least 6 itchy lesions on two different body areas and a high average itch score.
  • Study details: Participants will take an investigational medication and will be monitored for safety and how their bodies process the medication. They will need to complete a daily symptom diary. A placebo, an inactive substance that looks like the investigational medication but does not contain any medicine, may be used in the study.
  • Study Timelines and Visits: The study will last 42 to 44 weeks. The study requires 6 visits.

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