Loading clinical trials...

Safety and Tolerability of Repeat Courses of IM Alefacept | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety and Tolerability of Repeat Courses of IM Alefacept

An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis

NCT00233662•Biogen

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent.
•At least 16 years of age.
•Diagnosed with chronic plaque psoriasis and require systemic therapy.
•CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).

Exclusion Criteria

•Unstable erthrodermic or pustular psoriasis.
•Diagnosis of guttate psoriasis.
•Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
•Positive for HIV antibody.
•Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
•Evidence of active tuberculosis.
•Current treatment for active tuberculosis or tuberculosis prophylaxis.
•Female patients unwilling to practice effective contraception as defined by the investigator.
•Female patients who are pregnant or breast-feeding.
•Current enrollment in any other investigational drug study.
+1 more criteria

Locations (46)

University of California, Irvine

Irvine, California, United States

University of California, San Francisco

San Francisco, California, United States

Clinical Research Specialists, Inc.

Santa Monica, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Loyola University Medical Center

Maywood, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Central Dermatology

St Louis, Missouri, United States

University of Medicine and Dentistry Robert Wood Jonhson Medical School

New Brunswick, New Jersey, United States

New York University School of Medicine

New York, New York, United States

The Mount Sinai School of Medicine

New York, New York, United States

Key Dates

Start Date

December 1, 2002

Completion Date

December 1, 2005

Last Updated

August 23, 2023

Enrollment

400

Estimated participants

Conditions

Chronic Plaque Psoriasis

Interventions

Alefacept

DRUG

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03598790

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis

View study

COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03370133

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Tolerability of Repeat Courses of IM Alefacept

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis

Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

Study to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test