NCT00274352

A Study of Adalimumab to Treat Sarcoidosis of the Skin

A Double-Blind, Randomized, Placebo-Controlled Study of Adalimumab in the Treatment of Cutaneous Sarcoidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pariser, Robert J., M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis.

Detailed description

The cutaneous lesions of sarcoidosis are often disfiguring and can produce functional impairment. They tend to be hard to treat with most topical therapies and often require systemic medications which carry the risk of significant side effects. Often such treatments are withheld unless there is a need to use them for visceral involvement. There is thus an unmet need for safe and effective treatments for these patients. In addition there is essentially no controlled trial data for any treatments for cutaneous sarcoidosis. This study is intended to determine if adalimumab might offer a viable therapeutic option for this condition by comparing the response of cutaneous sarcoid lesions to this drug as compared to placebo.

Conditions

• Sarcoidosis

Interventions

Type	Name	Description
DRUG	adalimumab	Adalimumab 40 mg administered subcutaneously once weekly or placebo injection administered once weekly for 12 weeks, followed by open-label adalimumab 40 mg administered subcutaneously weekly for an additional 12 weeks.

Timeline

• Start date: 2006-09-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2006-01-10
• Last updated: 2013-05-22

Locations

1 site across 1 country: United States