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

NCT ID: NCT00669214

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-01-31

Brief Summary

This was a Phase IV randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of subcutaneous efalizumab in adult patients (18 years of age and older) with chronic moderate to severe plaque psoriasis with involvement of the scalp who had no previous exposure to efalizumab. The study consisted of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The study enrolled 100 patients. 11 patients were excluded from all analyses because of data issues.

Detailed Description

• Baselines for Raptiva group and placebo group at Day 84 are the same. The baseline is Day 0.
• Baselines for Raptiva group and placebo group at Day 168 are different. The baseline for Raptiva group at Day 168 is Day 0, but the baseline for Placebo group at Day 168 is Day 84

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Efalizumab

Group Type: EXPERIMENTAL

efalizumab

Intervention Type: DRUG

All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).

Interventions

efalizumab

All patients received a conditioning dose of efalizumab 0.7 mg/kg subcutaneously (SC) on Day 0, followed by 11 weekly doses of 1.0 mg/kg SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label treatment period from Day 84 (Week 12) through Day 168 (Week 24).

Intervention Type: DRUG

placebo

All patients received a conditioning dose of placebo equivalent SC on Day 0, followed by 11 weekly doses of placebo SC beginning on Day 7. After 12 weeks of blinded treatment, all patients continued into the open-label efalizumab treatment period from Day 84 (Week 12) through Day 168 (Week 24).

Intervention Type: DRUG

Other Intervention Names

Raptiva

Eligibility Criteria

Inclusion Criteria

• Provide written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) documents
• Be aged 18 years or older
• Have chronic (6 months or greater) moderate to severe plaque psoriasis with involvement of the scalp
• Have a whole body Physician's Global Assessment (PGA) rating of moderate (3) or severe (4) for psoriasis
• Have a scalp surface area affected by plaque psoriasis of 30% or more, assessed using Psoriasis Scalp Severity Index (PSSI)
• Have at least one of three clinical signs involving the scalp (erythema, induration, and desquamation) be rated as at least moderate (2) with the other two rated as at least slight (1) using PSSI
• Be a candidate for systemic therapy in the opinion of the investigator
• Be naive to efalizumab treatment
• For women of childbearing potential, must be willing to use a method of contraception acceptable to the investigator to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study and for 6 weeks after the last dose of efalizumab

Exclusion Criteria

• Have had previous exposure to efalizumab or a history of hypersensitivity to any of its components
• Are using any excluded therapy
• Have a history of drug or alcohol abuse in the past five years
• Have a history in the past 5 years of a serious infection or currently have an ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• Have any history of opportunistic infections (e.g., systemic fungal infections, parasites)
• Are seropositive for hepatitis B antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)
• Have a history of active tuberculosis or are currently undergoing treatment for tuberculosis, including latent tuberculosis with isoniazid
• Have the presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
• Are pregnant or breastfeeding
• Have a diagnosis of hepatic cirrhosis, regardless of cause or severity
• Have a history in the last 5 years of thrombocytopenia
• Have a history in the last 5 years of hemolytic anemia or any other clinically significant anemia
• Have been exposed to any experimental and/or unapproved drugs or treatments within 30 days or 5 half-lives, whichever is longer, before the screening visit
• Have been vaccinated with a live virus or live bacteria within the 14 days before the first dose of efalizumab
• Have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug (efalizumab or placebo equivalent) or would significantly interfere with the patient's ability to comply with the provisions of this protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivor Caro, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

ACD4412n

Identifier Type: -

Identifier Source: org_study_id