Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

Phase 2

Completed

• Conditions: Subacute Cutaneous Lupus Erythematosus
• Interventions: Drug: KRP203 - 1.2mg; Drug: Placebo to KRP203 - 1.2 mg

• Registration Number: NCT01294774
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

1. 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.

2. 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.

3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KRP203 - 1.2 mg	KRP203 - 1.2mg	-
Placebo to KRP203 - 1.2 mg	Placebo to KRP203 - 1.2 mg	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Siena, SI, Italy