A Phase IIIB Study to Evaluate the Mechanism of Action of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults With Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy
Overview
- Phase
- Phase 3
- Intervention
- Efalizumab
- Conditions
- Psoriasis
- Sponsor
- Rockefeller University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Number of Participants With Clinical Improvement of Target Lesions
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Detailed Description
The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up. At those visits, the patient can expect that a physical and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin will be taken.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •18 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
Exclusion Criteria
- Not provided
Arms & Interventions
psoriasis
moderate to severe plaque psoriasis
Intervention: Efalizumab
Outcomes
Primary Outcomes
Number of Participants With Clinical Improvement of Target Lesions
Time Frame: week 12
a single composite score based on quantitative measurement of epidermal acanthosis, qualitative expression of Keratin16 (histochemistry assessment) and quantitative measurement of K16 mRNA.
Secondary Outcomes
- 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.)