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

Sponsors and Collaborators:	University Hospital Inselspital, Berne Biogen-Dompé AG
Information provided by:	University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:	NCT00376129

Purpose

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.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Alefacept	Phase II

Drug Information available for: Alefacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:

primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
the percentage of patients reaching a pruritus score of none or mild [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Several immunological endpoints [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	January 2006
Study Completion Date:	January 2007

Arms	Assigned Interventions
I: Experimental	Drug: Alefacept 15 mg i.m. once weekly for 12 weeks

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376129

Locations

Switzerland
Inselspital Dermatology
Bern, Switzerland, 3110

Sponsors and Collaborators

University Hospital Inselspital, Berne

Biogen-Dompé AG

Investigators

Principal Investigator:

Nikhil Yawalkar, Prof

Dermatological Clinic Berne

More Information

Responsible Party:	Dermatological Clinic ( Prof. Yawalkar )
Study ID Numbers:	IST-EU-098-04-AME
Study First Received:	September 13, 2006
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00376129
Health Authority:	Switzerland: Swissmedic

Study placed in the following topic categories:

Alefacept
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases

Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Immune System Diseases
Therapeutic Uses
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009