Clinical trial NCT00794807: Safety and Tolerability of Repeat Courses of IM Alefacept
Official title: A 12-Week Open-Label Followed by 4-Week Double-Blind Study to Determine the Safety and Efficacy of an Extended Course of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Plaque Psoriasis
Keywords: Alefacept
Skin Diseases
Psoriasis
Skin Diseases, Papulosquamos
Therapeutic Uses
Dermatologic Agents
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2008-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Previous Biogen studies have provided experience with the tolerability, immunogenicity, and efficacy of a single and multiple 12-week courses of therapy of alefacept. At this stage, experience in larger studies, as well as the FDA-approved labeling, is confined to treatment courses of 12 weeks. The purpose of the present study is to offer an extended course of therapy with alefacept.

Detailed description: Twenty statistically matched patients (15 males, 5 females, aged between 28 and 70 years, median 50 years) with moderate to severe psoriasis (PASI: 7-36) were included in this study. They were treated with 15 mg alefacept i.m. weekly. Peripheral blood was taken prior to first alefacept application and then weekly until week five and thereafter every second week, until the end of treatment at week 13. At the same time points severity of disease and thereby possible reduction of symptoms was evaluated applying the PASI. Investigators analysing the samples were blinded to the outcome of the study. The protocol concerning human subjects was approved by the ethics commission of the Charité University Medicine Berlin Campus Mitte, Germany .

Eligibility criteria: Inclusion Criteria:

1. Must give written informed consent.
2. Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1.

Exclusion Criteria:

1. 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.
2. Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed).
3. Serious local infection (e.g., abscess) or systemic infection (e.g., pneumonia, septicemia) within the 3 months prior to the first dose of investigational drug.
4. Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
5. Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
6. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine or other systemic immunosuppressant agents within the 28 days prior to investigational drug administration.
7. Phototherapy, including Ultraviolet B (UVB) and Psoralen + Ultraviolet A (PUVA), within 28 days prior to investigational drug administration.
8. Known HIV+, known viral Hepatitis infection, known tuberculosis infection.

Primary outcomes:
measure: Safety of an extended courses of alefacept when administered to subjects with chronic plaque psoriasis. Safety parameters: Physical examinations; vital signs; infections; blood test: lymphocyte subset analysis (CD4+); and adverse events.
timeFrame: 12 + 4 weeks
Secondary outcomes:
measure: Efficacy of an extended course of alefacept when administered to subjects with chronic plaque psoriasis: Time to requirement of additional systemic therapies, Psoriasis Area and Severity Index (PASI); Physician Global Assessment (PGA).
timeFrame: 12 + 4 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Psoriasis Study center, The interdisciplinary group of Molecular Immunopathology
Study officials:
affiliation: Department of Dermatology and Allergy, Charité-Universitaetsmedizin Berlin
name: Wolfram Sterry, Prof. M.D.
role: STUDY_DIRECTOR
References: