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

December 3, 2007 updated by: Vertex Pharmaceuticals Incorporated

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

64

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of adverse events
Abnormal laboratory values
Abnormal ECGs and vital signs

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Investigators

  • Study Director: Robert Kauffman, MD, PhD, Vertex Pharmaceuticals Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 5, 2007

Last Update Submitted That Met QC Criteria

December 3, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX04-765-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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