Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT01294774 |
Recruitment Status :
Completed
First Posted : February 11, 2011
Last Update Posted : March 22, 2017
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Tracking Information | ||||
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First Submitted Date ICMJE | February 10, 2011 | |||
First Posted Date ICMJE | February 11, 2011 | |||
Last Update Posted Date | March 22, 2017 | |||
Study Start Date ICMJE | February 2011 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Subacute Cutaneous Lupus Erythematosus | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Estimated Enrollment ICMJE |
24 | |||
Actual Study Completion Date ICMJE | October 2012 | |||
Actual Primary Completion Date | October 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany, Greece, Italy | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01294774 | |||
Other Study ID Numbers ICMJE | CKRP203A2202 2010-019689-10 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Study Sponsor ICMJE | Novartis Pharmaceuticals | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Novartis | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |