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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

Primary Purpose

Chronic Plaque Psoriasis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
alefacept
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Chronic Plaque Psoriasis, Alefacept

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Dose regimen 1

Dose regimen 2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2008
Last Updated
August 25, 2014
Sponsor
Astellas Pharma Inc
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00674063
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Plaque Psoriasis
Keywords
Chronic Plaque Psoriasis, Alefacept

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dose regimen 1
Arm Title
2
Arm Type
Experimental
Arm Description
Dose regimen 2
Intervention Type
Drug
Intervention Name(s)
alefacept
Other Intervention Name(s)
Amevive, ASP0485
Intervention Description
IV
Primary Outcome Measure Information:
Title
Proportion of subjects receiving a Psoriasis Area and Severity Index (PASI) score of ≥75 compared to baseline
Time Frame
1 Week post treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects in each dosing regimen receiving a PASI score of ≥75 compared to baseline
Time Frame
1 Week post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use central contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6K 1L6
Country
Canada
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5L7
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140549 in the JapicCTI-RNo. field

Learn more about this trial

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

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