Clinical Trial: Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Eryt
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 Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: 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) [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus [ Time Frame: 12 weeks ]
- Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients [ Time Frame: 12 weeks ]
- Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient [ Time Frame: 12 weeks ]
- Measure the systemic features of SCLE using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: February 10, 2011
Date Started: February 2011
Date Completion:
Last Updated: March 20, 2017
Last Verified: March 2017
