Psoriasis
Conditions
Brief summary
The purpose of this research study is to see how well the medication Alefacept (Amevive®) works for continuous treatment of chronic plaque psoriasis. The US Food and Drug Administration (FDA) has approved Alefacept in an intermittent dosage schedule of 15 mg weekly injection for 12 weeks followed by 12 weeks off treatment.
Detailed description
To estimate the efficacy of continuous use of alefacept (15mg IM/week) in the treatment of moderate to severe chronic plaque type psoriasis as defined as Investigator Global Assessment (IGA) of 0 or 1 (clear or almost clear) or as a 75% reduction in Psoriasis Area and Severity Index (PASI).
Interventions
DRUGAlefacept
Alefacept's FDA indication is for the treatment of adult subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The approved dosing regimen is 15mg once weekly as an intramuscular injection or 7.5mg given once weekly as an intravenous bolus. The recommended regimen is a course of 12 weeks. Alefacept is supplied as a lyophilized powder. Alefacept contains LFA3-IgG1 Fusion Protein and excipient materials (citrate, glycine and sucrose).
Sponsors
Wake Forest University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must give written informed consent. * Subjects must be 18 years of age or older. * Subject must be adult males or non-pregnant, non-lactating females. * Female subjects of childbearing potential must state that they are using measures to avoid conception through active means including hormone replacement, intrauterine device, or abstinence. * Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase their health risk by study participation. * Subjects must be willing to receive an IM injection per protocol for 1 year. * Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1. Objectively this equates to Inclusion criteria of either: * IGA≥3 on a 0-5 scale and BSA≥10% * PASI ≥12 * Subjects may not be taking any other systemic therapies or receiving phototherapy during the duration of the study. Subjects are required a 4 week washout period from any systemic medication or phototherapy prior to enrolling in the study and starting treatment with alefacept. * There is no washout for topical corticosteroid medications. Stable dosing of topical corticosteroids may be used up until the first dosing visit.
Exclusion criteria
* Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded. * Subjects have guttate, pustular, erythrodermic or rapidly flaring psoriasis. * Current enrollment in any research study. * Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug. * Any subject who has a CD4\<250 cells/µL at study entry. * Treatment with another investigational drug or approved therapy within 28 days prior to study drug administration. * Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine, etanercept, efalizumab, infliximab, adalimumab or mofetil or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration. * Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration. * Known HIV+, known viral Hepatitis infection, known tuberculosis infection. * History of systemic malignancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 52 weeks | Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Alefacept Using CD4 Counts | 52 weeks | Number of participants experiencing CD4 cell counts below 250/uL |
Countries
United States
Participant flow
Recruitment details
Fifteen subjects with moderate to severe chronic plaque type psoriasis were recruited from the Wake Forest University Health Sciences Dermatology Clinic
Participants by arm
| Arm | Count |
|---|---|
| Alefacept All subjects will receive 15 mg of alefacept IM per week (unless CD4\<250 cells/µL, then dose will be withheld), for 16 weeks of treatment. After that they will be receive alefacept (15mg IM) once every 4 weeks for 8 months | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Desired Alternate Therapy | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Alefacept |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 15 |
| serious Total, serious adverse events | 2 / 15 |
Outcome results
Primary
Efficacy
Efficacy of continuous use of alefacept as defined as the number of participants with a 75% reduction in Psoriasis Area and Severity Index (PASI) score from Baseline to week 52
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alefacept | Efficacy | 1 #Participants |
Secondary
Safety of Alefacept Using CD4 Counts
Number of participants experiencing CD4 cell counts below 250/uL
Time frame: 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alefacept | Safety of Alefacept Using CD4 Counts | 2 Participants |