A Study to Evaluate the Effects of Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis

NCT00382512 | Completed Phase 1

• 1 other identifier: ACD2244g
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase I, randomized, placebo-controlled, single blind, parallel group, single-center study designed to evaluate immune responses during and after administration of 12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis.

Conditions

Plaque Psoriasis

Keywords

Moderate Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccinations in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C

• Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C.

Secondary Outcomes (6)

• Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C

• Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C

• Characterization of mean anti-<phi>X174 concentrations 2 and 4 weeks after the first and 2 and 4 weeks after the second <phi>X174 vaccinations during efalizumab treatment (Group A) compared with placebo (Group C)

• Characterization of mean concentrations of anti-tetanus IgG during treatment with efalizumab compared with placebo, representing a secondary humoral immune response

• Characterization of anti-pneumococcal antibody concentrations on FU Day 70 after pneumococcal vaccination on FU Day 42 compared with placebo

Interventions

Raptiva (efalizumab) DRUG

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Plaque psoriasis covering 8%-15% of the total BSA
• Diagnosis of plaque psoriasis for at least 6 months
• Body weight of ≤140 kg
• to 65 years old
• For women of childbearing potential and men who may father children, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study (the following methods of contraception are acceptable: condom; abstinence; oral, implantable or injectable contraceptives by the sexual partner; IUD, female condom, diaphragm with spermicide, cervical cap; 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
• History of tetanus vaccination

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 exacerbation during screening or at the time of enrollment
• History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
• History of opportunistic infections (e.g., systemic fungal infections, parasites)
• Seropositivity for human immunodeficiency virus (HIV)
• Pregnancy or lactation
• White blood cell (WBC) count \<4000/uL or \>14,000/uL
• Seropositivity for hepatitis B or C virus
• Hepatic enzymes ≥3 times the upper limit of normal
• Tetanus or pneumococcal vaccination during the 6 months prior to the start of the study (Treatment Day 0) or failure to complete a primary series of tetanus immunizations
• Known hypersensitivity reaction to tetanus or diphtheria toxoid
• Known hypersensitivity to any of the administered vaccinations or their components
• History of active tuberculosis (TB) or currently undergoing treatment for TB
• Positive purified protein derivative (PPD) (tuberculin) testing at screening (as defined by CDC Guidelines, see Appendix C for test assessment criteria and listing of high-risk groups)

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Interventions

efalizumab

Study Officials

• Wolfgang Dummer, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 29, 2006
• Study Start: May 1, 2003
• Last Updated: September 29, 2006

Record last verified: 2006-09