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

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00669214

Purpose

This is a Phase IV randomized, double-blind, placebo-controlled study 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 have had no previous exposure to efalizumab. The study will consist of a screening period, a double-blind treatment period, an open-label treatment period, and an observation/follow-up period. The planned enrollment for the trial is 100 patients.

Condition	Intervention	Phase
Psoriasis	Drug: efalizumab Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Phase IV Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of 1.0 mg/kg Efalizumab in Adult Patients With Moderate to Severe Plaque Psoriasis With Involvement of the Scalp

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Efalizumab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Proportion of patients achieving a ≥ 75% decrease of the PSSI [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients achieving a ≥ 75% decrease in the PSSI [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Proportion of patients achieving a ≥ 50% decrease in the PSSI [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Proportion of patients who achieve a whole body (including the scalp) PGA rating of clear (0), almost clear (1), or mild (2) [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Change in the Scalpdex (a quality-of-life instrument for scalp dermatitis) [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Change in a VAS of patient reported scalp itch [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
Change in BSA affected by psoriasis on the entire body [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	February 2008
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: efalizumab Subcutaneous repeating dose
2: Placebo Comparator	Drug: placebo Subcutaneous repeating dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 PGA rating of moderate (3) or severe (4) for psoriasis
Have a scalp surface area (SSA) affected by plaque psoriasis of 30% or more, assessed using 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 isonazid
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00669214

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Ivor Caro, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ACD4412n
Study First Received:	April 28, 2008
Last Updated:	July 28, 2009
ClinicalTrials.gov Identifier:	NCT00669214 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

Raptiva
Moderate plaque psoriasis
Severe plaque psoriasis
Scalp

Additional relevant MeSH terms:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on February 08, 2010