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.
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.
Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study.
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.
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.
Single group
Dupilumab
DrugPharmaceutical form: Injection solution Route of administration: Subcutaneous
Concentration of dupilumab in serum
Concentration of dupilumab in serum over time
Incidence of treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Incidence of anti-drug antibodies (ADA) to dupilumab over time
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Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
