Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167102
Status:
COMPLETED
Last Update Posted:
2019-05-22
First Post:
2005-09-09
Brief Title:
Alefacept in Patients With Severe Scalp Alopecia Areata
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Multi-Center Study to Evaluate The Safety and Therapeutic Efficacy of Intramuscular Administration of Alefacept in Patients With Chronic Severe Scalp Alopecia Areata
Status:
COMPLETED
Status Verified Date:
2019-05
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:
The purpose of this study is to examine prospectively the safety and efficacy of alefacept in the treatment of subjects with severe alopecia areata of the scalp Common features between psoriasis and alopecia areata including immunologic and therapeutic aspects suggest that alefacept which has been shown to be a safe and statistically significant beneficial therapeutic modality for the treatment of psoriasis may have therapeutic value in alopecia areata
Detailed Description:
Alopecia areata AA is an autoimmune condition characterised by a T-cell mediated attack on the hair follicle The inciting antigenic stimulus is unknown A dense peribulbar lymphocytic infiltrate and reproducible immunologic abnormalities are hallmark features of the condition The cellular infiltrate primarily consists of activated T-lymphocytes and antigen-presenting Langerhans cells T-lymphocytes play a critical role in the pathogenesis of disease The observance of hair regrowth in those with alopecia areata who are treated with cyclosporine a known inhibitor of T-cell function further confirms the central role of the T-lymphocytes in the development of the disease
Activation of T-cells is initiated by interaction of the T-cell receptor with the antigenmajor histocompatibility complex on the antigen-presenting cells Co-stimulatory interactions occur secondarily including binding of the T-cell CD2 receptor to the antigen-presenting cell ligand LFA-3 lymphocyte function-associated antigen-3 CD58 Induction of a molecular signaling cascade with resultant T-cell activation and proliferation ensues Abrogation of this activation may result in diminished or aborted expression of disease and thus suggests a potential therapeutic role for alefacept in the treatment of alopecia areata Alefacept is a bioengineered LFA-3Immunoglobulin fusion protein that binds to the CD2 T-cell receptor and interferes with the ligation of LFA-3 Binding of the immunoglobulin portion of the fusion protein to the FCy receptor on antigen-presenting cells potentiates apoptosis of CD-2 T-cells to thereby reduce the population of activated T-cells
Psoriasis is a T-cell mediated disorder that shares many immunologic features with alopecia areata Accordingly treatments that are effective in psoriasis often prove to be beneficial in alopecia areata Anthralin topical and intralesional steroids and cyclosporine are among several therapeutic agents that have efficacy in both disorders Based on the impressive therapeutic responses seen in those with psoriasis treated with alefacept a similarly beneficial outcome is tentatively anticipated with treatment of those with alopecia areata
Activation of T-cells is initiated by interaction of the T-cell receptor with the antigenmajor histocompatibility complex on the antigen-presenting cells Co-stimulatory interactions occur secondarily including binding of the T-cell CD2 receptor to the antigen-presenting cell ligand LFA-3 lymphocyte function-associated antigen-3 CD58 Induction of a molecular signaling cascade with resultant T-cell activation and proliferation ensues Abrogation of this activation may result in diminished or aborted expression of disease and thus suggests a potential therapeutic role for alefacept in the treatment of alopecia areata Alefacept is a bioengineered LFA-3Immunoglobulin fusion protein that binds to the CD2 T-cell receptor and interferes with the ligation of LFA-3 Binding of the immunoglobulin portion of the fusion protein to the FCy receptor on antigen-presenting cells potentiates apoptosis of CD-2 T-cells to thereby reduce the population of activated T-cells
Psoriasis is a T-cell mediated disorder that shares many immunologic features with alopecia areata Accordingly treatments that are effective in psoriasis often prove to be beneficial in alopecia areata Anthralin topical and intralesional steroids and cyclosporine are among several therapeutic agents that have efficacy in both disorders Based on the impressive therapeutic responses seen in those with psoriasis treated with alefacept a similarly beneficial outcome is tentatively anticipated with treatment of those with alopecia areata
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