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

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

Tracking Information
First Submitted Date  ICMJE September 13, 2006
First Posted Date  ICMJE September 14, 2006
Last Update Posted Date December 10, 2007
Study Start Date  ICMJE January 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: September 13, 2006)
primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Open-Label,Singel Center Study of Alefacept in Patients With Atopic Dermatitis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Drug: Alefacept
15 mg i.m. once weekly for 12 weeks
Study Arms  ICMJE Experimental: I
Intervention: Drug: Alefacept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2006)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00376129
Other Study ID Numbers  ICMJE IST-EU-098-04-AME
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Yawalkar, Dermatological Clinic
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Biogen-Dompé AG
Investigators  ICMJE
Principal Investigator: Nikhil Yawalkar, Prof Dermatological Clinic Berne
PRS Account University Hospital Inselspital, Berne
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP