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

NCT00376129 | Completed Phase 2

• 1 other identifier: IST-EU-098-04-AME
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• primary endpoints is the change of EASI at Visit 13 compared to baseline via paired t-Test

  24 weeks

Secondary Outcomes (3)

• 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.

  24 weeks

• the percentage of patients reaching a pruritus score of none or mild

  24 weeks

• Several immunological endpoints

  24 weeks

Study Arms (1)

I

EXPERIMENTAL

Drug: Alefacept

Interventions

Alefacept DRUG

15 mg i.m. once weekly for 12 weeks

I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Biogen-Dompé AG: collaborator

Study Sites (1)

Inselspital Dermatology

Bern, Canton of Bern, 3110, Switzerland

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Study Officials

• Nikhil Yawalkar, Prof

  Dermatological Clinic Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 14, 2006
• Study Start: January 1, 2006
• Study Completion: January 1, 2007
• Last Updated: December 10, 2007

Record last verified: 2007-12

Locations

CH (1)