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

• ClinicalTrials.gov Identifier: NCT00376129
• Recruitment Status: Completed
• First Posted: September 14, 2006
• Last Update Posted: December 10, 2007
• Sponsor: University Hospital Inselspital, Berne
• Collaborator: Biogen-Dompé AG
• Information provided by: University Hospital Inselspital, Berne

Tracking Information

• First Submitted Date: September 13, 2006
• First Posted Date: September 14, 2006
• Last Update Posted Date: December 10, 2007
• Study Start Date: January 2006
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: December 7, 2007): primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test [ Time Frame: 24 weeks ]
• Original Primary Outcome Measures (submitted: September 13, 2006): primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test

Current Secondary Outcome Measures (submitted: December 7, 2007)

• 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 ]
• the percentage of patients reaching a pruritus score of none or mild [ Time Frame: 24 weeks ]
• Several immunological endpoints [ Time Frame: 24 weeks ]

Original Secondary Outcome Measures (submitted: September 13, 2006)

• 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.
• Other additional endpoints are:
• the percentage of patients reaching a pruritus score of none or mild
• Several immunological endpoints

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Atopic Dermatitis

Intervention

Drug: Alefacept

15 mg i.m. once weekly for 12 weeks

Study Arms

Experimental: I

Intervention: Drug: Alefacept

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 13, 2006): 10
• Original Enrollment: Same as current
• Actual Study Completion Date: January 2007
• Primary Completion Date: Not Provided

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT00376129
• Other Study ID Numbers: IST-EU-098-04-AME
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof. Yawalkar, Dermatological Clinic
• Study Sponsor: University Hospital Inselspital, Berne
• Collaborators: Biogen-Dompé AG

Investigators

• Principal Investigator: Nikhil Yawalkar, Prof; Dermatological Clinic Berne

• PRS Account: University Hospital Inselspital, Berne
• Verification Date: December 2007