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

This study has been completed.
Sponsor:
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00205465
First received: September 13, 2005
Last updated: December 3, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Psoriasis
 Drug: VX-765
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

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

Estimated Enrollment: 64
Study Start Date: December 2004
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205465

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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 16, 2013