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

Genentech

Status and phase

Completed

Phase 1

Conditions

Plaque Psoriasis

Treatments

Drug: Raptiva (efalizumab)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00382512

ACD2244g

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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
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)
Presence of malignancy within the past 5 years, including lymphoproliferative disorders
Treatment with efalizumab (anti-CD11a) within the last 12 months
Previous administration of <phi>X174
Diagnosis of hepatic cirrhosis, regardless of cause or severity
Serum creatinine ≥2 times the upper limit of normal
Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
History of substance abuse within the last 5 years as judged by the Principal Investigator
Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
Systemic therapy for psoriasis (Screening Day -28 through FU Day 98)
Systemic immunosuppressive drugs for any indications (Screening Day -28 through FU Day 98)
Live virus or bacteria vaccines other than protocol specified (Screening Day -14 through Treatment Day 84)
Other vaccines or allergy desensitization (must be scheduled at least 14 days prior to Treatment Day 0 or after FU Day 98)
Other experimental drugs or treatments (within 90 days or five half-lives, whichever is longer, prior to Treatment Day 0 and through FU Day 98)
<beta>-Blockers, angiotensin-converting enzyme (ACE) inhibitors, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between Screening Day -28 and Treatment Day 84)