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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00376129
• Date of registration: 13/09/2006
• Prospective Registration: No
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis
• Scientific 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
• Date of first enrolment: January 2006
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00376129
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 2

Countries of recruitment

Switzerland

Contacts

• Name: Nikhil Yawalkar, Prof
• Affiliation: Dermatological Clinic Berne

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Atopic Dermatitis

Intervention(s)

Drug: Alefacept

Primary Outcome(s)

primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test [Time Frame: 24 weeks]

Secondary Outcome(s)

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]

Several immunological endpoints [Time Frame: 24 weeks]

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

Secondary ID(s)

IST-EU-098-04-AME

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen-Dompé AG