NCT03239106

A Study Examining the Medication Apremilast as Treatment for Chronic Itch

An Open Label Study of Apremilast in Chronic Idiopathic Pruritus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic Itch is a debilitating condition affecting many people. Currently, there are no FDA-approved treatments. Apremilast is an FDA-approved oral medication used to successfully treat the inflammatory skin disorder psoriasis and the inflammatory disorder psoriatic arthritis. This study examines if apremiliast taken twice daily relieves chronic itch.

Detailed description

There is no FDA-approved medication for chronic idiopathic pruritus (CIP). Apremilast has demonstrated notable activity and is approved for treatment in other pruritic inflammatory skin conditions such as psoriasis. The drug is currently being investigated as therapy for atopic dermatitis. Additionally, the investigators have preliminary data to suggest that apremilast's anti-inflammatory properties may work via neuromodulation targeting neuronal cytokine pathways. The proposed study plans to assess the efficacy of apremilast 30 mg BID in the setting of CIP. Durable response to a medication is typically seen within one to two months of starting an efficacious medication in subjects who respond. Therefore, the investigators have designed this study to end at Week 16 to definitively determine efficacy and conclude the study with confidence with regard to both efficacy and failure.

Conditions

• Itch

Interventions

Type	Name	Description
DRUG	Apremilast	Apremilast 30 mg BID daily

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-10-31
• Completion: 2019-09-19
• First posted: 2017-08-03
• Last updated: 2021-07-13
• Results posted: 2020-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study