Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris
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ClinicalTrials.gov Identifier: NCT01930175 |
Recruitment Status
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Active, not recruiting
First Posted
: August 28, 2013
Last Update Posted
: April 3, 2018
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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 | August 23, 2013 | ||||
First Posted Date ICMJE | August 28, 2013 | ||||
Last Update Posted Date | April 3, 2018 | ||||
Actual Study Start Date ICMJE | December 18, 2013 | ||||
Estimated Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Efficacy of a single intravenous dose of VAY736 in reducing the clinical disease activity in pemphigus vulgaris patinets. [ Time Frame: baseline, 12 weeks ] The effect of VAY736 on clinical disease activity will be measured by the change in Pemphigus Disease Area Index (PDAI) between baseline and week 12. PDAI is an assessment of skin and mucosal disease activity by the Investigator. The score incorporates the number and size of lesions across multiple skin locations and the mucous membranes.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01930175 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Efficacy and Safety of VAY736 in Patients With Pemphigus Vulgaris | ||||
Official Title ICMJE | A Randomized, Partial-blind, Placebo-controlled Trial Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of VAY736 in the Treatment of Patients With Pemphigus Vulgaris | ||||
Brief Summary | To evaluate the safety, tolerability and efficacy of a single intravneous infusion of VAY736, compared to placebo, in pemphigus vulgaris patients. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Pemphigus Vulgaris | ||||
Intervention ICMJE |
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Study Arms |
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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 | Active, not recruiting | ||||
Actual Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE |
30 | ||||
Estimated Study Completion Date | January 31, 2019 | ||||
Estimated Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years to 70 Years (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Austria, Bulgaria, Taiwan, United States | ||||
Removed Location Countries | Germany, Israel, Italy, United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01930175 | ||||
Other Study ID Numbers ICMJE | CVAY736X2203 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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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 | April 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |