Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376129
Status:
COMPLETED
Last Update Posted:
2007-12-10
First Post:
2006-09-13
Brief Title:
Open-LabelSingel Center Study of Alefacept in Patients With Atopic Dermatitis
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Open-LabelSingel Center Study to Evaluate the Safety and Efficacy of an Intramuskcular 12 Week-Course of Alefacept in Patients With Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Protocol Title Open-labelsingle 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
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 diseasewich 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None