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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Lupus Erythematosus, Discoid; Lupus Erythematosus, Systemic	Drug: R932333; Drug: Placebo	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Study Start Date :	August 2012
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Drug: R932333; R333 6% (60 mg/g), bid	Drug: R932333; R393233 6% (60 mg/g), bid; Other Name: R333
Placebo Comparator: Placebo; Placebo, bid	Drug: Placebo; Placebo, bid

Outcome Measures

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Primary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

United States, California
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90027
Stanford Dermatology
Redwood City, California, United States, 94063
United States, Indiana
Memorial Medical Group Clinical Research Institute
South Bend, Indiana, United States, 46601
United States, New York
North Shore Long Island Health System
Lake Success, New York, United States, 11042
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27104
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
University of Pennsylvania-Dermatology Research Office
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
University of Texas Medical School at Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Department of Dermatology
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
Canada, British Columbia
University of British Columbia, Vancouver Dermatology Clinical Trials Unit
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, Manitoba
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Ontario
Lynderm Research, Inc
Markham, Ontario, Canada, L3P 1A8

Sponsors and Collaborators

Rigel Pharmaceuticals

Investigators

Study Director:	Daniel Magilavy, MD	Rigel Pharmaceuticals, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Rigel Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01597050 History of Changes
Other Study ID Numbers:	C-932333-002
First Posted:	May 11, 2012
Results First Posted:	June 8, 2016
Last Update Posted:	July 14, 2016
Last Verified:	June 2016

Keywords provided by Rigel Pharmaceuticals:

Discoid Lupus Erythematosus; Systemic Lupus Erythematosus

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid; Connective Tissue Diseases; Autoimmune Diseases	Immune System Diseases; Lupus Erythematosus, Cutaneous; Skin Diseases