Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135733
Status:
TERMINATED
Last Update Posted:
2009-02-12
First Post:
2005-08-24
Brief Title:
A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Pilot Study of the Efficacy and Safety of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pharmaceutical sponsor withdrew financial support
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 find out how safe and effective an investigational drug called alefacept amevive is for the treatment of moderate to severe erosive mucosal lichen planus
Lichen planus is a skin disease that can last a long time and cause significant pain itching and scarring It can affect the mucous membranes area inside the mouth and vagina and these areas can become erosive sores can develop Currently there is no known cure for this disease
An investigational drug is one that has not been approved by the United States US Food and Drug Administration FDA to treat a particular condition or disease Alefacept has been approved to treat psoriasis a scaly skin rash A number of reports suggest that lichen planus develops for some of the same reasons as psoriasis but alefacept is not yet approved for the treatment of psoriasis
Lichen planus is a skin disease that can last a long time and cause significant pain itching and scarring It can affect the mucous membranes area inside the mouth and vagina and these areas can become erosive sores can develop Currently there is no known cure for this disease
An investigational drug is one that has not been approved by the United States US Food and Drug Administration FDA to treat a particular condition or disease Alefacept has been approved to treat psoriasis a scaly skin rash A number of reports suggest that lichen planus develops for some of the same reasons as psoriasis but alefacept is not yet approved for the treatment of psoriasis
Detailed Description:
Lichen planus is an inflammatory disorder that affects skin mucous membranes the skin in the mouth and vagina nails and hair It is thought that T-cells cells that help fight infection become activated and multiply faster than normal and that this contributes to the development of the skin sores
Alefacept works by slowing the rate at which T-cells become activated and helps to decrease the number of T-cells By blocking the activity and decreasing the number of T-cells Alefacept may help improve the disease and decrease the sores on the skin
Participants in this study will be randomly assigned to receive either alefacept or a placebo A placebo looks just like the study drug but contains no active medication Placebos help study doctors find out if the effects of the study drug are due to the drug itself or just because of being in the study This type of study design helps measure the true effectiveness of a treatment Participants have a 1 out of 2 chance of receiving alefacept and a 1 out of 2 chance of receiving placebo Neither participants nor the study doctors will know which group participants have been assigned to
The researchers expect to enroll 26 subjects in this study at research sites in the US About 16 subjects will be enrolled at Brigham and Womens Hospital and Massachusetts General Hospital
Biogen Idec Inc is the maker of alefacept and is the sponsor of this study
If taking part in another research study or have taken part in a research study in the last 28 days individuals will not be able to take part in this study Patients cannot be on multiple studies simultaneously however exceptions are made for non-invasive non-interventional and observational studies
This study will last 24 weeks with a total of 16 visits screening week 0 baseline weeks 1-12 week 16 and week 24 Participants will not be allowed to use any oral or injectable medications for lichen planus during this study Participants also will not be allowed to use certain creams for lichen planus during the study The study consists of weekly injections of the medication for 12 weeks and then a 12 week follow up period
All participants must be at least 18 years of age with a diagnosis of moderate to severe mucosal lichen planus Neither pregnant nor nursing women will be included in the study
Alefacept works by slowing the rate at which T-cells become activated and helps to decrease the number of T-cells By blocking the activity and decreasing the number of T-cells Alefacept may help improve the disease and decrease the sores on the skin
Participants in this study will be randomly assigned to receive either alefacept or a placebo A placebo looks just like the study drug but contains no active medication Placebos help study doctors find out if the effects of the study drug are due to the drug itself or just because of being in the study This type of study design helps measure the true effectiveness of a treatment Participants have a 1 out of 2 chance of receiving alefacept and a 1 out of 2 chance of receiving placebo Neither participants nor the study doctors will know which group participants have been assigned to
The researchers expect to enroll 26 subjects in this study at research sites in the US About 16 subjects will be enrolled at Brigham and Womens Hospital and Massachusetts General Hospital
Biogen Idec Inc is the maker of alefacept and is the sponsor of this study
If taking part in another research study or have taken part in a research study in the last 28 days individuals will not be able to take part in this study Patients cannot be on multiple studies simultaneously however exceptions are made for non-invasive non-interventional and observational studies
This study will last 24 weeks with a total of 16 visits screening week 0 baseline weeks 1-12 week 16 and week 24 Participants will not be allowed to use any oral or injectable medications for lichen planus during this study Participants also will not be allowed to use certain creams for lichen planus during the study The study consists of weekly injections of the medication for 12 weeks and then a 12 week follow up period
All participants must be at least 18 years of age with a diagnosis of moderate to severe mucosal lichen planus Neither pregnant nor nursing women will be included in the study
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