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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic

In brief

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.

Key facts

Study ID

NCT01597050

Run by

Rigel Pharmaceuticals

People needed

54

Starts

2012-08-01

Expected to finish

2013-09-01

Last updated by the study team

2016-07-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• University of Utah Department of Dermatology — Salt Lake City, Utah, United States
• Virginia Clinical Research, Inc — Norfolk, Virginia, United States
• University of British Columbia, Vancouver Dermatology Clinical Trials Unit — Vancouver, British Columbia, Canada
• Dermadvances Research — Winnipeg, Manitoba, Canada
• Lynderm Research, Inc — Markham, Ontario, Canada

Full record on ClinicalTrials.gov

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