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Safety and Tolerability of Repeat Courses of IM Alefacept

Primary Purpose

Chronic Plaque Psoriasis

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Alefacept

About this trial

This is an interventional treatment trial for Chronic Plaque Psoriasis focused on measuring Alefacept, Skin Diseases, Psoriasis, Skin Diseases, Papulosquamos, Therapeutic Uses, Dermatologic Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.
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).
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.
Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3.
Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration.
Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine 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.

Sites / Locations

Psoriasis Study center, The interdisciplinary group of Molecular Immunopathology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alefacept

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT00794807

First Posted

November 19, 2008

Last Updated

November 19, 2008

Sponsor

Charite University, Berlin, Germany

Collaborators

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00794807

Brief Title

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

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Plaque Psoriasis

Keywords

Alefacept, Skin Diseases, Psoriasis, Skin Diseases, Papulosquamos, Therapeutic Uses, Dermatologic Agents

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alefacept

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Alefacept

Other Intervention Name(s)

LFA-3/IgG1 fusion protein

Intervention Description

Alefacept=LFA-3/IgG1 fusion protein, once weekly, 15mg i.m.

Primary Outcome Measure Information:

Title

Time Frame

12 + 4 weeks

Secondary Outcome Measure Information:

Title

Time Frame

12 + 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must give written informed consent. Must require systemic therapy or phototherapy for their psoriasis, as determined by the investigator prior to Visit 1. 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. 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). 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. Any subject whose CD4+ lymphocyte count at study entry is less than 404 cells/mm3. Treatment with another investigational drug or approved therapy for investigational use within 28 days prior to investigational drug administration. Treatment with systemic retinoids, systemic steroids, methotrexate, cyclosporine, azathioprine, thioguanine 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfram Sterry, Prof. M.D.

Organizational Affiliation

Department of Dermatology and Allergy, Charité-Universitaetsmedizin Berlin

Official's Role

Study Director

Facility Information:

Facility Name

Psoriasis Study center, The interdisciplinary group of Molecular Immunopathology

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

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Safety and Tolerability of Repeat Courses of IM Alefacept

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