Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765
Phase 2
Completed
- Conditions
- Psoriasis
- Registration Number
- NCT00205465
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Abnormal ECGs and vital signs Incidence of adverse events Abnormal laboratory values
- Secondary Outcome Measures
Name Time Method 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