Phase 4 N=89 Randomized Double-blind Treatment

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

Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT00669214 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Feb 2011

Primary outcome: Primary: Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks — 0.111; 0.274 Proportion of patients — p=0.1054

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: efalizumab (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Genentech, Inc.
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks	0.111; 0.274	0.1054
SECONDARY Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks	0.273; 0.323	—
SECONDARY Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks	0.296; 0.452	0.2404
SECONDARY Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks	0.455; 0.500	—
SECONDARY Proportion of Patients Who Achieved a Whole Body (Including Scalp) Physician's Global Assessment (PGA) Rating of Clear (0), Almost Clear (1), or Mild (2) at 12 Weeks	0.111; 0.339	0.0366 sig
SECONDARY Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks	0.545; 0.387	—
SECONDARY Mean Change in Scalpdex Score at 12 Weeks	63.91; 67.83; 6.82; 10.15	0.1816
SECONDARY Mean Change in Scalpdex Score at 24 Weeks	63.91; 67.83; 7.81; 13.26	—
SECONDARY Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks	6.81; 7.47; 1.00; 2.19	0.0435 sig
SECONDARY Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks	6.81; 7.47; 2.06; 3.07	—
SECONDARY Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks	14.74; 19.61; 2.00; 6.43	0.0224 sig
SECONDARY Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks	14.74; 19.61; 4.53; 7.53	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00669214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.