Phase 2 Clinical Study in Psoriasis With Oral Investigational Drug VX-765

Psoriasis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of VX-765 in Subjects With Chronic Plaque Psoriasis Requiring Systemic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205465
• Other study ID #: VX04-765-301
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: December 3, 2007
• Start date: December 2004
• Est. completion date: September 2005

Study information

• Verified date: December 2007
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of VX-765 in subjects with chronic plaque psoriasis treated for 28 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2005
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• VX-765

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events
Primary	Abnormal laboratory values
Primary	Abnormal ECGs and vital signs
Secondary	PK/PD
Secondary	Target lesion score after 28 days of treatment
Secondary	Proportion of subjects meeting "clear" or "almost clear" criteria utilizing a static Physician's Global Assessment (sPGA)
Secondary	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
Secondary	Change in PASI from baseline to the end of 28 days of treatment