NCT01597050

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

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 Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	R932333	R393233 6% (60 mg/g), bid
DRUG	Placebo	Placebo, bid

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-05-11
• Last updated: 2016-07-14
• Results posted: 2016-06-08

Locations

15 sites across 2 countries: United States, Canada