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 It was later withdrawn in 2009 due to a potential risk of progressive multifocal leukoencephalopathy (PML).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

Pilot Trial to Assess Effect of CNI Conversion of Efalizumab on T Reg Cells

Phase 1
Withdrawn
Conditions
Autoimmune Diseases
Interventions
First Posted Date
2008-10-22
Last Posted Date
2013-05-14
Lead Sponsor
University of California, San Francisco
Registration Number
NCT00777400
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Efalizumab in the Treatment of Alopecia, Phase II

Phase 2
Withdrawn
Conditions
Alopecia Totalis
Interventions
First Posted Date
2008-09-04
Last Posted Date
2016-06-14
Lead Sponsor
Northwestern University
Registration Number
NCT00746980

TRUST Study: Raptiva ® in Hand & Foot Psoriasis

Phase 4
Terminated
Conditions
Chronic Plaque Psoriasis
Interventions
First Posted Date
2008-08-22
Last Posted Date
2014-02-27
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
76
Registration Number
NCT00739882
Locations
🇦🇹

University of Vienna Medical School, Vienna, Austria

Beta Cell Rescue in New Onset Type 1 Diabetes With Efalizumab

Phase 2
Withdrawn
Conditions
Diabetes Mellitus, Type 1
Interventions
Drug: placebo
First Posted Date
2008-08-20
Last Posted Date
2014-05-12
Lead Sponsor
Emory University
Registration Number
NCT00737763

A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

Phase 2
Withdrawn
Conditions
Kidney Transplantation
Interventions
First Posted Date
2008-08-07
Last Posted Date
2017-06-22
Lead Sponsor
Genentech, Inc.
Registration Number
NCT00729768

Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis

Phase 4
Conditions
Chronic Plaque Psoriasis
Interventions
First Posted Date
2008-06-30
Last Posted Date
2008-06-30
Lead Sponsor
Universita di Verona
Target Recruit Count
100
Registration Number
NCT00707070
Locations
🇮🇹

Univeristy Hospital, Verona, Italy

ChangE From Any Systemic psoriasiS therapY to Raptiva

Phase 4
Terminated
Conditions
Chronic Plaque Psoriasis
Interventions
First Posted Date
2008-06-16
Last Posted Date
2014-02-13
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
70
Registration Number
NCT00697593
Locations
🇨🇦

Probity Medical Research, City Waterloo, Ontario, Canada

Combined aPproach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study

Phase 1
Withdrawn
Conditions
Diabetic Macular Edema
Interventions
First Posted Date
2008-05-13
Last Posted Date
2016-08-26
Lead Sponsor
Johns Hopkins University
Registration Number
NCT00676559
Locations
🇺🇸

Sharp Rees-Stealy Medical Group, San Diego, California, United States

🇺🇸

Ophthalmic Consultants of Boston, Boston, Massachusetts, United States

🇺🇸

Eye Care Specialists, Kingston, Pennsylvania, United States

and more 7 locations

Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes

Phase 1
Terminated
Conditions
Type 1 Diabetes Mellitus
Hypoglycemia
Interventions
Biological: Allogeneic islets of Langerhans transplant
First Posted Date
2008-05-06
Last Posted Date
2017-10-25
Lead Sponsor
University of Minnesota
Target Recruit Count
23
Registration Number
NCT00672204
Locations
🇺🇸

Universtiy of Minnesota, Minneapolis, Minnesota, United States

A Study to Evaluate the Safety and Efficacy of Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp

Phase 4
Completed
Conditions
Psoriasis
Interventions
Drug: placebo
First Posted Date
2008-04-30
Last Posted Date
2017-06-06
Lead Sponsor
Genentech, Inc.
Target Recruit Count
89
Registration Number
NCT00669214
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