Alefacept

Overview

Immunosuppressive dimeric fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fc (hinge, CH2 and CH3 domains) portion of human IgG1. Produced by CHO cells, mW is 91.4 kD.

Background

Indication

As an immunosuppressive drug, Alefacept can be used for treatment of moderate to severe chronic plaque psoriasis

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Alefacept in Kidney Transplant Recipients	2011/09/14	NCT01433770	Not Applicable	Withdrawn	University Hospitals Cleveland Medical Center
Alefacept and Allogeneic Hematopoietic Stem Cell Transplantation	2011/03/22	NCT01319851	Not Applicable	Terminated	Emory University
Alefacept in Patients With Relapsed/Refractory Aplastic Anemia	2010/12/28	NCT01267643	Phase 1	Terminated	The Cleveland Clinic
Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease	2010/10/22	NCT01226420	Phase 2	Terminated	Dana-Farber Cancer Institute
A Pilot Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients	2010/07/16	NCT01163799	Phase 1	Terminated	Northwestern University
Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy	2009/08/06	NCT00953329	Phase 4	Terminated	John Murray
Study to Evaluate the Safety and Efficacy of Alefacept (Amevive) in Subjects With Moderate to Severe Atopic Dermatitis	2009/01/30	NCT00832585	Phase 4	Completed	Rush University Medical Center
A Pilot Study of Alefacept for the Treatment of Pityriasis Rubra Pilaris	2008/12/30	NCT00815633	Phase 4	Terminated	Joshua Zeichner
Safety and Tolerability of Repeat Courses of IM Alefacept	2008/11/20	NCT00794807	Phase 4	Completed	Charite University, Berlin, Germany
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis	2008/06/06	NCT00692172	Phase 3	Completed	Astellas Pharma Inc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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