Study of the Drug Efalizumab (Raptiva), for Adult Patients With Moderate to Severe Plaque Psoriasis

NCT00115076 | Completed Phase 3 Results

• 1 other identifier: JKR-0511
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.

Conditions

Psoriasis

Keywords

skin; psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Improvement of Target Lesions

  a single composite score based on quantitative measurement of epidermal acanthosis, qualitative expression of Keratin16 (histochemistry assessment) and quantitative measurement of K16 mRNA.

  week 12

Secondary Outcomes (1)

• Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI)

  Day 0, day 14, day 42, day 84, Days 112, 140, and 168. PASI has been measured at those timepoints but outcome is related to Baseline and Day 84.

Study Arms (1)

psoriasis

EXPERIMENTAL

moderate to severe plaque psoriasis

Drug: Efalizumab

Interventions

Efalizumab DRUG

24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection

Also known as: Raptiva

psoriasis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Plaque psoriasis covering \>10% of total BSA
• Diagnosis of plaque psoriasis for at least 6 months
• PASI score \>=12 (see Appendix A) or Linear PASI score of \>= 8.0 at screening (see Appendix B)
• In the opinion of the investigator, candidate for systemic therapy for psoriasis:
• Who has not been previously treated (naive to systemic treatment) OR
• Who has had prior treatment with systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil (MMF), thioguanine, hydroxyurea, sirolimus, azathioprine, 6-MP, etanercept)
• Body weight of \<140 kg
• to 75 years old. As the risk of Efalizumab in childhood is unknown, those \< 18years will be excluded from the study
• For women of childbearing potential or in men whose partners may become pregnant, willingness to use an acceptable method of contraception to prevent pregnancy for the duration of the study (while receiving study medication and 3 months following). Acceptable methods of contraception include use of a condom; abstinence; use by sexual partner of oral implantable or injectable contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap; or a sterile sexual partner
• Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study

You may not qualify if:

• Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
• History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies or fusion proteins that contain an Ig Fc region
• Clinically significant psoriasis flare during screening or on the first treatment day
• Treatment with efalizumab (anti-CD11a) within the last 12 months before enrollment
• Pregnancy or lactation. As the risk of Efalizumab in pregnancy is unknown, pregnant women will be excluded from the study
• History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• History of active tuberculosis (TB) or currently undergoing treatment for TB. PPD testing or chest X-ray is required for high-risk subjects (see Appendix D).
• Subjects with a positive PPD (not due to BCG vaccination) or chest X-ray will be excluded
• History of opportunistic infections (e.g., systemic fungal infections, parasites)
• Seropositivity for human immunodeficiency virus (HIV)
• Seropositivity for hepatitis B or C virus
• Hepatic enzymes \>3 times the upper limits of normal (ULN)
• Diagnosis of hepatic cirrhosis, regardless of cause or severity
• WBC count \<4000μL or \>14,000/μL
• Serum creatinine \>2 times the ULN

Sponsors & Collaborators

• Rockefeller University: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Rockefeller University

New York, New York, 10065, United States

Location

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• Johnson-Huang LM, Pensabene CA, Shah KR, Pierson KC, Kikuchi T, Lentini T, Gilleaudeau P, Sullivan-Whalen M, Cueto I, Khatcherian A, Hyder LA, Suarez-Farinas M, Krueger JG, Lowes MA. Post-therapeutic relapse of psoriasis after CD11a blockade is associated with T cells and inflammatory myeloid DCs. PLoS One. 2012;7(2):e30308. doi: 10.1371/journal.pone.0030308. Epub 2012 Feb 10.

  PMID: 22348003 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

efalizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: James G. Krueger MD, PhD
• Organization: Rockefeller University

kruegej@rockefeller.edu

212-327-7730

Study Officials

• James Krueger, MD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2005
• First Posted: June 21, 2005
• Study Start: August 4, 2003
• Primary Completion: May 18, 2009
• Study Completion: April 6, 2011
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-02

Locations

US (2)