Psoriasis
Conditions
Keywords
skin, psoriasis
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.
Interventions
DRUGEfalizumab
24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection
Sponsors
Genentech, Inc.
Rockefeller University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 * Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Improvement of Target Lesions | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Clinical response defined as PASI improvement over 75% at week 12. |
Countries
United States
Participant flow
Pre-assignment details
1 patient was not assigned to any arm.
Participants by arm
| Arm | Count |
|---|---|
| Psoriasis moderate to severe plaque psoriasis
Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection | 30 |
| Psoriasis moderate to severe plaque psoriasis
Efalizumab: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Psoriasis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 9 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: week 12
Population: 28 out of 30 participants completed the study. Then clinical improvement was determined only for those 28.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Psoriasis | Number of Participants With Clinical Improvement of Target Lesions | 18 Participants |
Secondary
Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI)
Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Clinical response defined as PASI improvement over 75% at week 12.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psoriasis | Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI) | Baseline | 34.58 score on a scale | Standard Deviation 17.48 |
| Psoriasis | Assessment of Overall Clinical Response as Measured by Psoriasis Area and Severity Index (PASI) | Week 12 | 12.94 score on a scale | Standard Deviation 10.68 |