NCT00338143
Completed
Phase 3
A Phase IIIb, Open-Label, Multicenter Study to Evaluate the Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis, Including Those Who Are Receiving Concomitant Antipsoriatic Therapies or Have Recently Transitioned From Systemic Therapies
ConditionsPsoriasis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Genentech, Inc.
- Enrollment
- 1200
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This is a Phase IIIb, open label, uncontrolled, multicenter study designed to evaluate the safety and tolerability of 12 weeks of subcutaneously administered efalizumab in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy and may also be receiving topical therapies, PUVA, or UVB phototherapy during the efalizumab treatment period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Plaque psoriasis covering \>=10% of total BSA
- •Plaque psoriasis diagnosed for at least 6 months
- •In the opinion of the investigator, a candidate for systemic therapy for psoriasis
- •18-75 years old
- •Body weight \<=125 kg
- •For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 3 months after the last dose of efalizumab
Exclusion Criteria
- •Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- •Pregnancy or lactation
- •Clinically significant psoriasis flare during screening or at the time of enrollment
- •History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- •History of opportunistic infections (e.g., systemic fungal infections, parasites)
- •Seropositivity for hepatitis B or C virus
- •Seropositivity for human immunodeficiency virus (HIV)
- •History of active tuberculosis (TB) or currently undergoing treatment for TB
- •Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
- •Previous treatment with efalizumab (anti-CD11a)
Outcomes
Primary Outcomes
Not specified
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