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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic

Intervention / Treatment
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* Drug: R932333
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug: R932333<br>R333 6% (60 mg/g), bid | Drug: R932333<br>* R393233 6% (60 mg/g), bid<br>* Other names: R333;|
| Placebo Comparator: Placebo<br>Placebo, bid | Drug: Placebo<br>* Placebo, bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions. | 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. | Up to Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discoid Lupus Erythematosus, Systemic Lupus Erythematosus