Lichen PlanusPhase 2NCT00135733
A Safety and Efficacy Study of Alefacept in the Treatment of Moderate to Severe Erosive Mucosal Lichen Planus
A Phase 2 study testing Amevive (Alefacept) in people with Lichen Planus, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lichen Planus
- What is being tested?
- Amevive (Alefacept)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02115
About this study
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
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.
Read the 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.
- Conditions
- Lichen Planus
- Being tested
- Amevive (Alefacept), Placebo
- Keywords
- Lichen Planus, Mucosal lichen planus, Alefacept, T-cell mediated, subcutaneous medication, Autoimmune disease
- Medical subject headings
- Lichen Planus, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amevive (Alefacept)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Amevive Receives: Drug: Amevive (Alefacept) |
| B | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistically significant changes in pain level
Statistically significant changes in appearance of lesions (sores)
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startApr 2004
- Primary completionDec 2004
- Study completionDec 2004
Why it stopped: Pharmaceutical sponsor withdrew financial support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Stanford University, Biogen
- Investigators
- Alexandra B. Kimball, MD, MPH, Principal investigator, CURTIS - Clinical Unit for Research Trials in Skin at Partners (MGH and BWH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135733
- Sponsor's protocol ID
- 2004P002141
- Status last verified
- Feb 2009
- First submitted
- 24 Aug 2005
- Last updated
- 12 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
Stewart EG, Vulvar Lichen Planus, Up To Date, version 12.3, Aug 2004.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00135733
- Acronym / sponsor ID
- 2004P002141
- Conditions
- Lichen Planus
- Keywords
- Lichen Planus, Mucosal lichen planus, Alefacept, T-cell mediated, subcutaneous medication, Autoimmune disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pharmaceutical sponsor withdrew financial support.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Stanford University, Biogen
- Study start
- Apr 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 26 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Amevive (Alefacept)Amevive |
| B | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amevive (Alefacept) | Drug | A |
| Placebo | Drug | B |
Primary outcome
Statistically significant changes in pain level
Statistically significant changes in appearance of lesions (sores)
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Pharmaceutical sponsor withdrew financial support.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2009.
- BackgroundDaoud 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.
- BackgroundStewart EG, Vulvar Lichen Planus, Up To Date, version 12.3, Aug 2004.
Related trials for Lichen Planus
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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A Study to Assess the Efficacy and Safety of GIA632 Across a Range of Doses in Participants With Moderate to Severe Cutaneous Lichen Planus
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Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study.
Lichen Penis Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra B. Kimball, MD, MPH principal investigator
CURTIS - Clinical Unit for Research Trials in Skin at Partners (MGH and BWH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amevive (Alefacept) in people with Lichen Planus, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Pharmaceutical sponsor withdrew financial support.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistically significant changes in pain level. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00135733, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2009.