Clinical Trial: Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus

Brief Summary: The purpose of this study is to determine the safety, efficacy and tolerability of topical R333 ointment in Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) patients with active discoid lesions.

Detailed Summary: This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the preliminary efficacy, safety, tolerability, and pharmacokinetics of topical R333 ointment formulated at 6% (60 mg/g) in DLE and SLE patients with active discoid lesions.
Sponsor: Rigel Pharmaceuticals

Current Primary Outcome: Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. [ Time Frame: Up to Week 4 ]

Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.


Original Primary Outcome: Decrease in the Total Combined Erythema and Scaling Score of All Treated Lesions. [ Time Frame: Baseline and Day 28 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rigel Pharmaceuticals

Dates:
Date Received: May 9, 2012
Date Started: August 2012
Date Completion:
Last Updated: June 15, 2016
Last Verified: June 2016