Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

Study Overview
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Brief Summary
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This study will assess the safety and efficacy of KRP203 in clinically active subacute cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard treatment, such as antimalarials.

Official Title
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A Multi-center, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy and Tolerability of KRP203 in Patients With Active Subacute Cutaneous Lupus Erythematosus

Conditions
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Subacute Cutaneous Lupus Erythematosus

Intervention / Treatment
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* Drug: KRP203 - 1.2mg
* Drug: Placebo to KRP203 - 1.2 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients,18 to 65 years of age inclusive, who have been defined as having SCLE based on the typical clinical picture and the characteristic histopathological features as described by Sontheimer et al. at least three months before study entry (screening) Exclusion Criteria: Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the Investigator to be clinically significant. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren's syndrome are allowed to enter the study at the Investigator's discretion. Patients who have been treated with: immunoglobulins and/or monoclonal antibodies within 6 months prior to randomization. rituximab, cyclophosphamide, or other immunosuppressive treatments with effects potentially lasting over 6 months, within 12 months prior to randomization. a medium or high dose (≥ 1 mg prednisone or equivalent per body weight kg) corticosteroid therapy in the last 8 weeks prior to randomization. antimalarial agents (hydroxychloroquine, chloroquine or quinacrine) in the last 6 weeks prior to randomization. biologic therapies, such as etanercept, within the last 4 weeks prior to randomization. any other immunosuppressive or immunomodulatory therapy such as methotrexate, azathioprine, cyclosporin A or mycophenolate, thalidomide, retinoids or dapsone in the last 4 weeks prior to randomization. total lymphoid irradiation or bone marrow transplantation. Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: KRP203 - 1.2 mg<br> | Drug: KRP203 - 1.2mg<br> <br> |
| Placebo Comparator: Placebo to KRP203 - 1.2 mg<br> | Drug: Placebo to KRP203 - 1.2 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of KRP203 in reduction of severity of symptoms, as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus |  | 12 weeks | 
| Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients |  | 12 weeks | 
| Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient |  | 12 weeks | 
| Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus erythematosus, skin lupus