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

NCT06293053 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • Prurigo Nodularis

Interventions

DRUG

Dupilumab

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-15
Primary Completion
2027-10-28
Completion
2027-11-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06293053 on ClinicalTrials.gov