NCT06012448

The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is studying a drug called dupilumab to learn about its safety and its effect as a treatment for participants with dermal hypersensitivity reaction. This study will help better understand why and how dermal hypersensitivity reaction occurs and how dupilumab might help treat this condition.

Detailed description

Dermal hypersensitivity reaction is a skin rash that can happen as a reaction to a known trigger or it can happen for unknown reasons. Not a lot is known about why the rash occurs and what happens to the immune system to cause this rash. Dupilumab, a biologic drug that is given as an injection under the skin, may treat dermal hypersensitivity reaction. This study tries to better understand dermal hypersensitivity reaction and how the immune system responds to dupilumab.

Conditions

• Dermal Hypersensitivity Reaction

Interventions

Type	Name	Description
DRUG	Dupilumab	Patients will start by getting dupilumab 600 milligram (mg) subcutaneously at week 0, followed by 300 mg every 2 weeks starting at week 2. The last dose will be given at week 24. In addition, participants will have visits at the research site for examinations, provide health information, laboratory draws, skin biopsies (at certain time points). Participation in the study will last approximately 28 weeks.

Timeline

• Start date: 2023-10-02
• Primary completion: 2025-01-07
• Completion: 2025-03-25
• First posted: 2023-08-25
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study