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OpenTrials
Completed

NCT Number: NCT00205465

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-765

Drug

Primary outcomes

  1. Incidence of adverse events

  2. Abnormal laboratory values

  3. Abnormal ECGs and vital signs

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 20, 2005
Registry last updated
Dec 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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