Back to resultsPhase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
VX-765
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: Diagnosed with chronic plaque psoriasis for at least 6 months Prior systemic therapy Exclusion Criteria: Current or prior history of illness precluding use of immunomodulatory therapy.
Sites / Locations
Outcomes
Primary Outcome Measures
Incidence of adverse events
Abnormal laboratory values
Abnormal ECGs and vital signs
Secondary Outcome Measures
PK/PD
Target lesion score after 28 days of treatment
Proportion of subjects meeting "clear" or "almost clear" criteria utilizing a static Physician's Global Assessment (sPGA)
Proportion of subjects demonstrating ≥ 50% and ≥ 75% decrease from baseline in Psoriasis Area and Severity Index (PASI) to the end of 28 days of treatment
Change in PASI from baseline to the end of 28 days of treatment
Full Information
NCT ID
NCT00205465
First Posted
September 13, 2005
Last Updated
December 3, 2007
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00205465
Brief Title
Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of VX-765 in Subjects With Chronic Plaque Psoriasis Requiring Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
5. Study Description
Brief Summary
To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
VX-765
Primary Outcome Measure Information:
Title
Incidence of adverse events
Title
Abnormal laboratory values
Title
Abnormal ECGs and vital signs
Secondary Outcome Measure Information:
Title
PK/PD
Title
Target lesion score after 28 days of treatment
Title
Proportion of subjects meeting "clear" or "almost clear" criteria utilizing a static Physician's Global Assessment (sPGA)
Title
Proportion of subjects demonstrating ≥ 50% and ≥ 75% decrease from baseline in Psoriasis Area and Severity Index (PASI) to the end of 28 days of treatment
Title
Change in PASI from baseline to the end of 28 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria:
Diagnosed with chronic plaque psoriasis for at least 6 months
Prior systemic therapy
Exclusion Criteria:
Current or prior history of illness precluding use of immunomodulatory therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kauffman, MD, PhD
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765
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