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

  • STATUS
    Recruiting
  • End date
    Nov 3, 2027
  • participants needed
    18
  • sponsor
    Sanofi
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Updated on 14 May 2025
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Summary

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.

Details
Condition Prurigo Nodularis
Age 6months - 17years
Clinical Study IdentifierNCT06293053
SponsorSanofi
Last Modified on14 May 2025

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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