A Randomized, Placebo-Controlled, Single-Blind, Parallel-Group Study to Evaluate the Effects of 12 Weekly Subcutaneous Doses of 1.0 mg/kg Efalizumab on Immune Responses in Subjects With Moderate Plaque Psoriasis

Genentech, Inc.0 sites60 target enrollmentMay 2003

ConditionsPlaque Psoriasis

DrugsRaptiva (efalizumab)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Plaque Psoriasis
Sponsor: Genentech, Inc.
Enrollment: 60
Primary Endpoint: 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
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

•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
•18 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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

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

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
Percentage of subjects with positive skin test reactions to tetanus and Candida-recall antigens on FU Day 77 after washout from efalizumab compared with baseline.