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

Phase 2

Completed

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 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 & 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.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, bid
Drug: R932333	R932333	R333 6% (60 mg/g), bid

Primary Outcome Measures

Name	Time	Method
Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (15): Wallace Rheumatic Study Center
🇺🇸
Los Angeles, California, United States
Stanford Dermatology
🇺🇸
Redwood City, California, United States
Memorial Medical Group Clinical Research Institute
🇺🇸
South Bend, Indiana, United States
North Shore Long Island Health System
🇺🇸
Lake Success, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Oklahoma Medical Research Foundation
🇺🇸
Oklahoma City, Oklahoma, United States
University of Pennsylvania-Dermatology Research Office
🇺🇸
Philadelphia, Pennsylvania, United States
Metroplex Clinical Research Center
🇺🇸
Dallas, Texas, United States
University of Texas Medical School at Houston
🇺🇸
Houston, Texas, United States
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Wallace Rheumatic Study Center
🇺🇸Los Angeles, California, United States