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

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.

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.