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A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus

Primary Purpose

Lichen Planus

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amevive (Alefacept)
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Planus focused on measuring Lichen Planus, Mucosal lichen planus, Alefacept, T-cell mediated, subcutaneous medication, Autoimmune disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria: Written informed consent, authorize release and use of protected health information At least 18 years of age Diagnosis of moderate to severe mucosal lichen planus No systemic (oral or injectable) treatment of lichen planus for 4 weeks prior to starting study drug. Willing to forgo changes in topical treatment (creams) for 4 weeks before receiving the study drug and during the course of the study. Off of topical tacrolimus or pimecrolimus for 4 weeks prior to starting the study drug CD4+ T lymphocyte counts must be above the lower limit of normal laboratory value Key Exclusion Criteria: Clinically significant abnormal laboratory values Skin lesions currently undiagnosed, but suspicious for malignancy Other skin disease that might interfere with lichen planus status assessments. History of malignancy other than basal cell carcinomas or fewer than 3 squamous cell carcinomas Exposure to systemic therapy for lichen planus within 4 weeks prior to enrollment. Previous exposure to alefacept

Sites / Locations

  • Clinical Unit for Research Trials in Skin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Amevive

Placebo

Outcomes

Primary Outcome Measures

Statistically significant changes in pain level
Statistically significant changes in appearance of lesions (sores)

Secondary Outcome Measures

Statistically significant changes in severity of itching
Statistically significant changes in redness, amount of body surface area involved, number of sores, and or depth of involvement
Statistically significant changes in quality of life

Full Information

First Posted
August 24, 2005
Last Updated
February 10, 2009
Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Stanford University, Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00135733
Brief Title
A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Terminated
Why Stopped
Pharmaceutical sponsor withdrew financial support.
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital, Stanford University, Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 U.S. About 16 subjects will be enrolled at Brigham and Women's 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus
Keywords
Lichen Planus, Mucosal lichen planus, Alefacept, T-cell mediated, subcutaneous medication, Autoimmune disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Amevive
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Amevive (Alefacept)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Statistically significant changes in pain level
Title
Statistically significant changes in appearance of lesions (sores)
Secondary Outcome Measure Information:
Title
Statistically significant changes in severity of itching
Title
Statistically significant changes in redness, amount of body surface area involved, number of sores, and or depth of involvement
Title
Statistically significant changes in quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: Written informed consent, authorize release and use of protected health information At least 18 years of age Diagnosis of moderate to severe mucosal lichen planus No systemic (oral or injectable) treatment of lichen planus for 4 weeks prior to starting study drug. Willing to forgo changes in topical treatment (creams) for 4 weeks before receiving the study drug and during the course of the study. Off of topical tacrolimus or pimecrolimus for 4 weeks prior to starting the study drug CD4+ T lymphocyte counts must be above the lower limit of normal laboratory value Key Exclusion Criteria: Clinically significant abnormal laboratory values Skin lesions currently undiagnosed, but suspicious for malignancy Other skin disease that might interfere with lichen planus status assessments. History of malignancy other than basal cell carcinomas or fewer than 3 squamous cell carcinomas Exposure to systemic therapy for lichen planus within 4 weeks prior to enrollment. Previous exposure to alefacept
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra B. Kimball, MD, MPH
Organizational Affiliation
CURTIS - Clinical Unit for Research Trials in Skin at Partners (MGH and BWH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Unit for Research Trials in Skin
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Daoud MS, Pittelkow MR, Fitzpatrick's Dermatology in General Medicine, sixth edition, ed. Freedberg IM, Eisen AZ, Wolff K, Austen KF, Goldsmith LA, Katz SI, McGraw-Hill, pp 463-476, 2003.
Results Reference
background
Citation
Stewart EG, Vulvar Lichen Planus, Up To Date, version 12.3, Aug 2004.
Results Reference
background

Learn more about this trial

A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus

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