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

Lupus Erythematosus, Systemic Clinical Trial

— SKINDLE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597050
• Other study ID #: C-932333-002
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2012
• Last updated: September 27, 2013
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Rigel Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of SLE or DLE (DLE confirmed histologically prior to randomization).

• At least 2 active discoid lesions secondary to SLE or DLE prior to study entry, each with a minimum Erythema Rating Score of = 2. At least 1 of the active discoid lesions must have been present (by history) for = 3 weeks prior to screening.

• Patients who are taking azathioprine, hydroxychloroquine, chloroquine, quinacrine, methotrexate, and/ or oral glucocorticoids, must be receiving a stable daily dose = 4 weeks prior to randomization and must remain on the same dose throughout the study. Azathioprine, hydroxychloroquine, chloroquine, quinacrine, or methotrexate must be initiated = 8 weeks prior to randomization.

Exclusion Criteria:

• Congenital or acquired immunodeficiency including: HIV infection, agammaglobulinemias, T cell deficiencies or HTLV-1 infection at any time prior to the study.

• Lymphoproliferative disease or previous total lymphoid irradiation.

• Uncontrolled or poorly controlled hypertension.

• History of psoriasis, eczema, or relevant atopy.

• Exposure to excessive or chronic UV radiation (e.g., tanning beds, sunbathing, solarium, phototherapy) within 2 weeks prior to randomization or during the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

Intervention

Drug:
• R932333
R393233 6% (60 mg/g), bid
• Placebo
Placebo, bid

Locations

Country	Name	City	State
Canada	Lynderm Research, Inc	Markham	Ontario
Canada	University of British Columbia, Vancouver Dermatology Clinical Trials Unit	Vancouver	British Columbia
Canada	Dermadvances Research	Winnipeg	Manitoba
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	University of Texas Medical School at Houston	Houston	Texas
United States	North Shore Long Island Health System	Lake Success	New York
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	Virginia Clinical Research, Inc	Norfolk	Virginia
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	University of Pennsylvania-Dermatology Research Office	Philadelphia	Pennsylvania
United States	Stanford Dermatology	Redwood City	California
United States	University of Utah Department of Dermatology	Salt Lake City	Utah
United States	Memorial Medical Group Clinical Research Institute	South Bend	Indiana
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Rigel Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in the total combined Erythema and Scaling score of all treated lesions.		Baseline and Day 28	Yes