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OpenTrials
Completed

NCT Number: NCT00674063

A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis

Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis

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Key information

Conditions

Chronic Plaque Psoriasis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Moncton, New Brunswick, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Body weight between 100kg and 150kg
  • Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10%
  • Candidate for phototherapy or systemic therapy for Psoriasis
  • CD4 + T lymphocyte counts > lower limit of normal

Exclusion criteria

  • Clinically significant abnormal hematology values or blood chemistry values
  • ALT or AST value of ≥ 3x the upper limit of normal
  • Other types of Psoriasis
  • Serious infection within 3 months prior to 1st dose of study drug
  • Antibody positive for HIV
  • History of malignancy
  • History of severe allergic or anaphylactic reactions
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease

Treatment and study plan

Alefacept

Drug

IV

Other names: Amevive, ASP0485

Primary outcomes

  1. Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline

    Time frame: 1 Week post treatment

Secondary outcomes

  1. Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline

    Time frame: 1 Week post treatment

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Biogen

Registry information

Official study title

A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Weekly Intravenous Administration of 7.5mg and 0.075mg/kg Alefacept in Subjects Weighing Between 100kg and 150kg, With Moderate to Severe Chronic Plaque Psoriasis

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
May 7, 2008
Registry last updated
Aug 26, 2014

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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