NCT00674063

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_3

Geographic Reach
2 countries

17 active sites

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

July 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
Last Updated

August 26, 2014

Status Verified

August 1, 2014

Enrollment Period

9 months

First QC Date

May 6, 2008

Last Update Submit

August 25, 2014

Conditions

Chronic Plaque Psoriasis

Keywords

Chronic Plaque PsoriasisAlefacept

Outcome Measures

Primary Outcomes (1)

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

    1 Week post treatment

Secondary Outcomes (1)

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

    1 Week post treatment

Study Arms (2)

1

EXPERIMENTAL

Dose regimen 1

Drug: alefacept

2

EXPERIMENTAL

Dose regimen 2

Drug: alefacept

Interventions

alefaceptDRUG

IV

Also known as: Amevive, ASP0485
12

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Hot Springs, Arkansas, 71913, United States

Location

Unknown Facility

Fridley, Minnesota, 55432, United States

Location

Unknown Facility

Omaha, Nebraska, 68144, United States

Location

Unknown Facility

East Windsor, New Jersey, 08520, United States

Location

Unknown Facility

Stony Brook, New York, 11790, United States

Location

Unknown Facility

Lake Oswego, Oregon, 97035, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Johnston, Rhode Island, 02919, United States

Location

Unknown Facility

Goodlettsville, Tennessee, 37072, United States

Location

Unknown Facility

Nashville, Tennessee, 37215, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Unknown Facility

Moncton, New Brunswick, E1C 8X3, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 1V6, Canada

Location

Unknown Facility

London, Ontario, N6K 1L6, Canada

Location

Unknown Facility

Waterloo, Ontario, N2J 1C4, Canada

Location

Unknown Facility

Windsor, Ontario, N8W 5L7, Canada

Location

Unknown Facility

Montreal, Quebec, H3H 1V4, Canada

Location

MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 AntigensMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesImmunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMembrane ProteinsRecombinant Fusion ProteinsRecombinant Proteins

Study Officials

  • Use central contact

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

July 1, 2003

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

August 26, 2014

Record last verified: 2014-08

Locations

CA(6)US(11)