NCT00205465

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

September 13, 2005

Last Update Submit

December 3, 2007

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

  • Incidence of adverse events

  • Abnormal laboratory values

  • Abnormal ECGs and vital signs

Secondary Outcomes (5)

  • 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

Interventions

VX-765DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with chronic plaque psoriasis for at least 6 months
  • Prior systemic therapy

You may not qualify if:

  • Current or prior history of illness precluding use of immunomodulatory therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

belnacasan

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert Kauffman, MD, PhD

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

December 1, 2004

Study Completion

September 1, 2005

Last Updated

December 5, 2007

Record last verified: 2007-12