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Sponsors and Collaborators: |
University Hospital Inselspital, Berne Biogen-Dompé AG |
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Information provided by: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00376129 |
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 |
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Atopic Dermatitis |
Drug: Alefacept |
Phase II |
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 |
Enrollment: | 10 |
Study Start Date: | January 2006 |
Study Completion Date: | January 2007 |
Arms | Assigned Interventions |
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I: Experimental |
Drug: Alefacept
15 mg i.m. once weekly for 12 weeks
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Inselspital Dermatology | |
Bern, Switzerland, 3110 |
Principal Investigator: | Nikhil Yawalkar, Prof | Dermatological Clinic Berne |
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 |
Alefacept Hypersensitivity Dermatitis, Atopic Genetic Diseases, Inborn Skin Diseases |
Hypersensitivity, Immediate Skin Diseases, Eczematous Skin Diseases, Genetic Dermatitis |
Immune System Diseases Therapeutic Uses Dermatologic Agents Pharmacologic Actions |