A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00673556

Enrollment

195

Registered

2008-05-07

Start date

2003-10-31

Completion date

2005-05-31

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Plaque Psoriasis

Keywords

Chronic Plaque Psoriasis, Alefacept

Brief summary

To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate

Detailed description

Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension

Interventions

DRUGalefacept

Intramuscular (IM)

DRUGplacebo

Intramuscular (IM)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area * Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective * CD4+ T lymphocyte counts at or above the lower limit of normal

Exclusion criteria

* Clinically significant abnormal hematology values or blood chemistry values * AST or ALT ≥ 3x the upper limit of normal * Other types of Psoriasis * Serious infection within the 3 months prior to the first dose of study drug * History of drug or alcohol abuse within the past 2 years * Antibody positive for HIV * History of malignancy * History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease * Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug * Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug * Current treatment with any therapy for tuberculosis * Previous exposure to Alefacept * Nursing mothers, pregnant women, and women planning to become pregnant during the study

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50	14 Weeks

Secondary

Measure	Time frame
Proportion of patients achieving a PASI score of ≥ 50 any time during study	Throughout study
Proportion of patients achieving a PASI score of ≥ 75	14 Weeks

Countries

Austria, Belgium, Canada, Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026