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 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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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:

Genetics Home Reference related topics: psoriatic arthritis

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 Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.

Secondary Outcome Measures:

Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Proportion of patients who achieved a ≥ 75% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 12 weeks (Day 84) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Proportion of patients who achieved a ≥ 50% decrease in PSSI score at 24 weeks (Day 168) relative to baseline. The PSSI assessed: 1) extent of scalp psoriasis (i.e., percentage of area involved), which was scored from 1 to 6, where 1 = <10% and 6 = 90-100%); and 2) clinical signs (erythema, induration, and desquamation), which were scored from 0 to 4, where 0 = Absent and 4 = Severest possible). The sum of the separate scores for erythema, induration, and desquamation was multiplied by the score for the involved area. The PSSI score range was therefore 0-72.
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 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 12 weeks (Day 84)

Physician's Global Assessment (PGA) scale:

0: Clear. No signs of plaque psoriasis.
1. Almost clear. Just perceptible erythema and just perceptible scaling.
2. Mild disease. Light pink erythema with minimal scaling.
3. Moderate disease. Dull red, clearly distinguishable erythema with diffuse scaling, some thickening.
4. Severe disease. Deep/dark red erythema with clearly obvious and diffuse scaling and thickening.
Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Proportion of patients who achieved a whole body (including scalp) PGA rating of 0, 1, or 2 at 24 weeks (Day 168) For details on the PGA scale, refer to the Secondary Outcome Measure Description for 12 weeks.
Mean Change in Scalpdex Score at 12 Weeks [ Time Frame: The two time points for Mean Change in Scalpdex Score at 12 Weeks are Day 0 and Day 84 ] [ Designated as safety issue: No ]
Mean change in Scalpdex score at 12 weeks (Day 84) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
Mean Change in Scalpdex Score at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Mean change in Scalpdex score at 24 weeks (Day 168) relative to baseline. The Scalpdex point scoring scale ranges from 1=NEVER, 2='RARELY', 3='SOMETIMES', 4='OFTEN' and 5='ALL THE TIME'.
Mean Change in a Visual Analog Scale (VAS) of Scalp Itch at 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Mean change in VAS of patient-reported scalp itch at 12 weeks (Day 84) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching."
Mean Change in VAS of Patient-reported Scalp Itch at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Mean change in VAS of patient-reported scalp itch at 24 weeks (Day 168) relative to baseline. The Visual Analog Scale (VAS) of patient-reported scalp itch measured the severity of a patient's scalp itch on a scale of 0 to 10, where 0 was "no itching," 5 was "moderate itching," and 10 was "severe itching."
Mean Change in Percentage of Whole Body (Including Scalp) Body Surface Area (BSA) Affected by Psoriasis at 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 12 weeks (Day 84) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).
Mean Change in Percentage of Whole Body (Including Scalp) BSA Affected by Psoriasis at 24 Weeks [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Mean change in percentage of whole body (including scalp) BSA affected by psoriasis at 24 weeks (Day 168) relative to baseline. BSA was assessed by percentage of sites affected per body segment (head, trunk, and limbs). Investigators were instructed to use the "rule of palm" to estimate lesional skin BSA (1% BSA = palm to first interphalangeal joint).

Enrollment:	89
Study Start Date:	February 2008
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Efalizumab	Drug: 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). Other Name: Raptiva
Placebo Comparator: Placebo	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).

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

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 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

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

Additional Information:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00669214 History of Changes
Other Study ID Numbers:	ACD4412n
Study First Received:	April 28, 2008
Results First Received:	August 24, 2010
Last Updated:	January 18, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

Raptiva
Moderate plaque psoriasis
Severe plaque psoriasis
Scalp

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012