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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00205465
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: VX-765 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : December 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources




Primary Outcome Measures :
  1. Incidence of adverse events
  2. Abnormal laboratory values
  3. Abnormal ECGs and vital signs

Secondary Outcome Measures :
  1. PK/PD
  2. Target lesion score after 28 days of treatment
  3. Proportion of subjects meeting "clear" or "almost clear" criteria utilizing a static Physician's Global Assessment (sPGA)
  4. 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
  5. Change in PASI from baseline to the end of 28 days of treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205465


Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Robert Kauffman, MD, PhD Vertex Pharmaceuticals Incorporated

Responsible Party: Robert Kauffman, M.D., Ph.D, Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00205465     History of Changes
Other Study ID Numbers: VX04-765-301
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases