NCT05649098

Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders

Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders: a Single-Site Pilot Study

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

Severe itch is a common symptom of many genetic skin disorders and leads to a negative impact on patient quality of life. The investigators hypothesize that: a) intervention with dupilumab will improve itch in patients with pruritic genetic inflammatory skin disorders, even those not recognized to be Th2-driven; and b) the administration of dupilumab will be well-tolerated, regardless of underlying genetic skin disorder. The total clinical study duration will be 26 months (104 Weeks). The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.

Conditions

• Skin Diseases

Interventions

Type	Name	Description
DRUG	Dupilumab	The treatment period will include a 16-week open-label phase and a 20-month long-term extension phase for those who qualify and wish to continue.

Timeline

• Start date: 2023-06-12
• Primary completion: 2025-06-30
• Completion: 2026-06-01
• First posted: 2022-12-13
• Last updated: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study