MedPath

Efalizumab

Generic Name
Efalizumab
Drug Type
Biotech
CAS Number
214745-43-4
Unique Ingredient Identifier
XX2MN88N5D
Background

Humanized IgG1 kappa isotype monoclonal antibody that binds to human CD11a. Efalizumab has a molecular weight of approximately 150 kilodaltons and is produced in a Chinese hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin. The FDA approved efalizumab in 2003. It was later withdrawn in 2009 due to a potential risk of progressive multifocal leukoencephalopathy (PML).

Indication

For the treatment of adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.

Associated Conditions
Moderate to Severe Chronic Plaque Psoriasis

Early Conversion From Tacrolimus to Efalizumab Maintenance Therapy in Kidney Transplant Recipients

Phase 1
Terminated
Conditions
Kidney Transplantation
Chronic Kidney Failure
Interventions
First Posted Date
2007-05-11
Last Posted Date
2014-01-27
Lead Sponsor
Emory University
Target Recruit Count
5
Registration Number
NCT00472082
Locations
πŸ‡ΊπŸ‡Έ

Emory University, Atlanta, Georgia, United States

Efalizumab for Treatment of Patients With Moderate to Severe Psoriasis

Phase 3
Completed
Conditions
Moderate to Severe Psoriasis
First Posted Date
2007-03-02
Last Posted Date
2016-11-21
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Registration Number
NCT00442650
Locations
πŸ‡¨πŸ‡­

Merck Serono Medical Information Office, Geneva, Switzerland

Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy

Phase 1
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2006-08-25
Last Posted Date
2018-06-14
Lead Sponsor
University of California, Davis
Target Recruit Count
12
Registration Number
NCT00368654
Locations
πŸ‡ΊπŸ‡Έ

University of California, Davis Medical Center Department of Dermatology, Sacramento, California, United States

Pilot Study of Raptiva to Treat Sjogren's Syndrome

Phase 2
Terminated
Conditions
Sjogren's Syndrome
Interventions
First Posted Date
2006-06-26
Last Posted Date
2015-12-21
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Target Recruit Count
10
Registration Number
NCT00344448
Locations
πŸ‡ΊπŸ‡Έ

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Study to Evaluate Efalizumab in Adults With Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic Therapies

Phase 3
Completed
Conditions
Psoriasis
First Posted Date
2006-06-20
Last Posted Date
2014-03-04
Lead Sponsor
Genentech, Inc.
Target Recruit Count
1200
Registration Number
NCT00338143

A Study to Evaluate Raptiva in Subjects With Chronic Moderate or Worse Plaque Psoriasis Who Have Had an Inadequate Response to an Anti-TNF Agent

Phase 4
Completed
Conditions
Psoriasis
Interventions
First Posted Date
2006-06-15
Last Posted Date
2015-07-23
Lead Sponsor
Genentech, Inc.
Target Recruit Count
73
Registration Number
NCT00336973

A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Plaque Psoriasis Involving the Hands and/or Feet

Phase 4
Completed
Conditions
Psoriasis
First Posted Date
2006-04-07
Last Posted Date
2017-02-15
Lead Sponsor
Genentech, Inc.
Target Recruit Count
75
Registration Number
NCT00312026

Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva

Phase 2
Withdrawn
Conditions
Discoid Lupus Erthematosus of the Scalp
Interventions
First Posted Date
2006-03-29
Last Posted Date
2020-02-19
Lead Sponsor
The Cleveland Clinic
Registration Number
NCT00308204
Locations
πŸ‡ΊπŸ‡Έ

Cleveland Clinic, Cleveland, Ohio, United States

A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis

Phase 4
Completed
Conditions
Plaque Psoriasis
First Posted Date
2006-03-14
Last Posted Date
2007-07-13
Lead Sponsor
Derm Research, PLLC
Target Recruit Count
20
Registration Number
NCT00302445
Locations
πŸ‡ΊπŸ‡Έ

Dermatology Associates, PLLC, Seattle, Washington, United States

πŸ‡ΊπŸ‡Έ

Derm Research, PLLC, Louisville, Kentucky, United States

A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis

Phase 4
Completed
Conditions
Candidates for Systemic Therapy for Psoriasis
Psoriasis
Interventions
First Posted Date
2006-02-06
Last Posted Date
2018-04-03
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
189
Registration Number
NCT00287118
Locations
πŸ‡¨πŸ‡­

Medical Information Switzerland, Geneva, Switzerland

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