Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Biogen-Dompé AG
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00376129
First received: September 13, 2006
Last updated: December 7, 2007
Last verified: December 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


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
Experimental: I 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Alefacept
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014