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efalizumab

Phase 4

Rheumatoid Arthritis | Monoclonal antibody | Immunology |XOMA Royalty Corporation|Trials Updated: Jun 24, 2005

efalizumab development status

Highest phase Phase 4 run by Genentech, Inc. (NCT00336973)
Phase scored for XOMAPhase 2
Registered trials 9 across 3 sponsors since Apr 2002

efalizumab target and mechanism

Molecular targetITGAL, ITGB2
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment45

FDA Designations

No designations recorded

efalizumab clinical trials

efalizumab · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00034203Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.Rheumatoid Arthritis
COMPLETED- Analytics
PHASE2COMPLETED
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Rheumatoid ArthritisUnlock trial analytics

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT

Interventions

NameTypeDescription
efalizumabDRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion criteria: * Clinical diagnosis of moderate to severe rheumatoid arthritis. * On stable dose of methotrexate. * 18 to 80 years of age. * Less than 275 lbs. Exclusion criteria: * Joint replacement surgery within 60 days of the start of drug dosing. * Intra-articular cortisone injections w...

Countries:United States
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Frequently asked questions about efalizumab

What is efalizumab used for?

Efalizumab is an investigational monoclonal antibody being studied for psoriatic arthritis and rheumatoid arthritis, both immune-mediated inflammatory conditions. It is in Phase 1 clinical development, and no regulatory approval for any indication has been established. XOMA Royalty Corporation is the developer.

What does efalizumab target?

Efalizumab targets ITGAL and ITGB2, which together form the integrin receptor LFA-1. By binding these targets, efalizumab acts as an inhibitor of LFA-1-mediated cellular adhesion and T-cell activation, a mechanism relevant to inflammatory joint diseases such as psoriatic arthritis and rheumatoid arthritis.

Who is developing efalizumab?

Efalizumab is being developed by XOMA Royalty Corporation, which trades under the ticker XOMA. The company is responsible for advancing the monoclonal antibody through clinical development for psoriatic arthritis and rheumatoid arthritis.

What phase is efalizumab in?

Efalizumab is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA for any indication. The Phase 1 program has focused on safety, efficacy, and pharmacokinetics in patients with psoriatic arthritis.

What clinical trials is efalizumab in?

Efalizumab has been evaluated in two completed clinical trials. NCT00051662 was a Phase 1 study of safety, efficacy, and pharmacokinetics in psoriatic arthritis, enrolling 45 patients. NCT00034203 was a Phase 2 study of safety and efficacy in rheumatoid arthritis conducted in the United States.

Is efalizumab approved by the FDA?

No. Efalizumab is an investigational monoclonal antibody in Phase 1 clinical development and has not been approved by the FDA for psoriatic arthritis, rheumatoid arthritis, or any other indication. It remains under study by XOMA Royalty Corporation.