NCT04306965

Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab

Apremilast 30 mg BID Combined With Dupilumab for the Treatment of Recalcitrant Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label phase 2 investigational study of efficacy and safety of apremilast 30 mg twice a day (BID) in chronic atopic dermatitis when added to the FDA approved treatment dupilumab for atopic dermatitis that is not providing adequate clinical responses.

Detailed description

The purpose of this study is to determine if apremilast as a combined treatment for atopic dermatitis will provide increased efficacy outcomes in subjects who are currently using the FDA approved therapy of dupilumab but have responded only partially or inadequately to this therapy. Our hypothesis is that adding apremilast will allow patients to go from an inadequate response to dupilumab to an adequate response defined as an Investigator Global Assessment (IGA) of 0 (clear) or 1 (almost clear).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Apremilast	30 mg twice daily (BID)

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-06-23
• Completion: 2022-08-18
• First posted: 2020-03-13
• Last updated: 2024-04-19
• Results posted: 2024-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study