Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disorders

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05649098
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Skin Diseases

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 12, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2031
Completion
Jun 1, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-Label Dupilumab

Primary Outcome Measure

Change in Itch [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Dermatology CTU
Amy Paller (PRINCIPAL_INVESTIGATOR)

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