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Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status

Completed

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Alefacept

About this trial

This is an interventional diagnostic trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

must give written informed consent
must be at least 18 years of age
must have been diagnosed with atopic dermatitis fulfilling the diagnostic criteria of Hanfin und Rajka and having active inflammation
must have a severity score of 6-9 according to Langeland and Rajka and an EASI of > 20
must have a PGA of "moderate","severe", or "very severe" and a pruritus score of "moderate" or"severe" at baseline
must have total lymphocyte counts and CD4+ lymphocyte counts at or above the lower limit of normal

Exclusion Criteria:

Patients with severe diseases, that might interfere with the evaluation of AD
Patiens with severe diseases of other organ systems that might put the patient on risk during the study or might interfere with the evaluations
Patients older than 65 years
Systemic treatment for atopic dermatitis ( e.g. cyclosporine, mycophenolat- mofetil,inferferon-gamma, PUVA) or systemic treatment with immunosuppressive/immunomodulating substances( e.g. azathioprin,methotrexate,biologics or hyposensitization - therapy) for other indications within 28 days prior to baseline
local treatment for atopic dermatitis with pimecrolimus/tacrolimus, steroids > class III, unstable use of steroid< class III, emollients or local antiseptics/antibiotics, UVB,UVA within 14 days prior to baseline
Serious local infection (e.g. cellulitis, abscess)or systemic infection (e.g. pneumonia,septicemia) within 3 months prior to the first dose of Alefacept
Congenital or acquired immunodeficiency syndrome
History of an invasive malignancy. Patients with a history of treatmend squamous cell and/or basal call carcinomas limited to the skin are not exluded
Laboratory or clinical evidence of active tuberculosis
Current treatment with any therapy for active tuberculosis or tuberculosis prophylaxis
for female patients, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. the rhythm method is not to be used as the sole method of contraception. Female patients considering becoming pregnant while in the study are excluded
female patients who are currently pregnant or breast-feeding
abnormal chemistry, i.e., LFTs greater than three times the upper limit of normal
Current enrollment in any other investigational drug study
previous participation in this study or previous studies with Alefacept

Sites / Locations

Inselspital Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test

Secondary Outcome Measures

Additional enppoints are the percentage of patients reaching a PGA of "clear" or "almost clear" and/or a reduction of EASI of>=50 or >=75% compared to baseline at any visit after baseline.

the percentage of patients reaching a pruritus score of none or mild

Several immunological endpoints

Full Information

NCT ID

NCT00376129

First Posted

September 13, 2006

Last Updated

December 7, 2007

Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

Biogen-Dompé AG

1. Study Identification

Unique Protocol Identification Number

NCT00376129

Brief Title

Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis

Official Title

Open-Label,Singel Center Study to Evaluate the Safety and Efficacy of an Intramuskcular 12 Week-Course of Alefacept in Patients With Atopic Dermatitis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

Biogen-Dompé AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Protocol Title: Open-label,single center study to evaluate the savety and efficacy of an intramuscular 12 week-course of Alefacept in patients with atopic dermatitis. Study Phase: II Study Design: Open-label, single center Primary Study Objective: to determine the safety and efficacy of one course of Alefasept when administered as a 15 mg intramuscular ( IM) injektion to patients with atopic dermatitis Secondary Study Objective: to investigate key immunological parameters involved in the pathology of this common skin disease to interpret the clinical findings Number of patients: 10 Study Population: Male and female patients, at least 18 years of age with atopic dermatitis, aktive inflammation, a severity score of 6-9 according to Langeland and Rajika and an EASI of >20 Treatment Groups: Alefacept will be administered as a 15 mg IM injection once a week for 12 weeks, followed by a 12-week follow-up period.

Detailed Description

Atopic dermatitis is a common chronic eczematous skin disease,wich often begins early in infancy and runs a course of remissions and exacerbations. T-lymphocytes play a prominent role in this skin disease. they represent the majority of skin-infiltrating cells and patients suffering from AD also have increased levels of activated circulating T cells and increased levels of markers of lymphocyte activation such as L-selectin and IL-2R.

6. Conditions and Keywords

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

Atopic Dermatitis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Alefacept

Intervention Description

15 mg i.m. once weekly for 12 weeks

Primary Outcome Measure Information:

Title

primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Additional enppoints are the percentage of patients reaching a PGA of "clear" or "almost clear" and/or a reduction of EASI of>=50 or >=75% compared to baseline at any visit after baseline.

Time Frame

24 weeks

Title

the percentage of patients reaching a pruritus score of none or mild

Time Frame

24 weeks

Title

Several immunological endpoints

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: must give written informed consent must be at least 18 years of age must have been diagnosed with atopic dermatitis fulfilling the diagnostic criteria of Hanfin und Rajka and having active inflammation must have a severity score of 6-9 according to Langeland and Rajka and an EASI of > 20 must have a PGA of "moderate","severe", or "very severe" and a pruritus score of "moderate" or"severe" at baseline must have total lymphocyte counts and CD4+ lymphocyte counts at or above the lower limit of normal Exclusion Criteria: Patients with severe diseases, that might interfere with the evaluation of AD Patiens with severe diseases of other organ systems that might put the patient on risk during the study or might interfere with the evaluations Patients older than 65 years Systemic treatment for atopic dermatitis ( e.g. cyclosporine, mycophenolat- mofetil,inferferon-gamma, PUVA) or systemic treatment with immunosuppressive/immunomodulating substances( e.g. azathioprin,methotrexate,biologics or hyposensitization - therapy) for other indications within 28 days prior to baseline local treatment for atopic dermatitis with pimecrolimus/tacrolimus, steroids > class III, unstable use of steroid< class III, emollients or local antiseptics/antibiotics, UVB,UVA within 14 days prior to baseline Serious local infection (e.g. cellulitis, abscess)or systemic infection (e.g. pneumonia,septicemia) within 3 months prior to the first dose of Alefacept Congenital or acquired immunodeficiency syndrome History of an invasive malignancy. Patients with a history of treatmend squamous cell and/or basal call carcinomas limited to the skin are not exluded Laboratory or clinical evidence of active tuberculosis Current treatment with any therapy for active tuberculosis or tuberculosis prophylaxis for female patients, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. the rhythm method is not to be used as the sole method of contraception. Female patients considering becoming pregnant while in the study are excluded female patients who are currently pregnant or breast-feeding abnormal chemistry, i.e., LFTs greater than three times the upper limit of normal Current enrollment in any other investigational drug study previous participation in this study or previous studies with Alefacept

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nikhil Yawalkar, Prof

Organizational Affiliation

Dermatological Clinic Berne

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inselspital Dermatology

City

Bern

ZIP/Postal Code

3110

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis

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