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

NCT00669214 | Completed Phase 4 Results

• 1 other identifier: ACD4412n
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Keywords

Raptiva; Moderate plaque psoriasis; Severe plaque psoriasis; Scalp

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Who Achieved a ≥ 75% Decrease in Psoriasis Scalp Severity Index (PSSI) Score at 12 Weeks

  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.

  Week 12

Secondary Outcomes (11)

• Proportion of Patients Who Achieved a ≥ 75% Decrease in PSSI Score at 24 Weeks

  Week 24

• Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 12 Weeks

  Week 12

• Proportion of Patients Who Achieved a ≥ 50% Decrease in PSSI Score at 24 Weeks

  Week 24

• 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

  Week 12

• Proportion of Patients Who Achieved a Whole Body (Including Scalp) PGA Rating of Clear (0), Almost Clear (1), or Mild (2) at 24 Weeks

  Week 24

Study Arms (2)

Efalizumab

EXPERIMENTAL

Drug: efalizumab

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

efalizumab 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).

Also known as: Raptiva

Efalizumab

placebo 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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Psoriasis

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Since the completion of this study, efalizumab has been voluntarily withdrawn from the U.S. market because of a safety issue.

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Ivor Caro, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 6, 2017
• Results First Posted: February 14, 2011

Record last verified: 2017-05