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Safety and Effectiveness of Efalizumab to Treat Oral Lichen Planus
This study has been completed.
Sponsors and Collaborators: Washington University School of Medicine
Genentech
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00133107
  Purpose

This study is to determine whether efalizumab 1.0mg/kg given by subcutaneous injection for 12 weeks is effective in treating oral lichen planus.

This is a 20 week, single center, open-label pilot study to enroll 5 subjects.


Condition Intervention
Lichen Planus, Oral
Drug: efalizumab

Drug Information available for: Efalizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Single Center, Open-Label, Pilot Study Evaluating the Safety and Effectiveness of Subcutaneous Efalizumab in the Treatment of Oral Lichen Planus

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • primary efficacy measure will be oral mucosal surface area involvement

Secondary Outcome Measures:
  • clinical lesion score
  • ten centimeter visual analogue pain scale
  • oral health impact profile-14 questionnaire
  • cutaneous surface area involvement

Estimated Enrollment: 5
Study Start Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to provide written informed consent
  • Subject able and willing to comply with study requirements for the full duration of the study.
  • Age > 18 years.
  • Subject has a diagnosis of oral lichen planus deemed by the investigator to be of sufficient severity to require systemic agents. The diagnosis can be made by biopsy proven oral lichen planus or biopsy proven cutaneous lichen planus in the setting of a subject with oral disease consistent with lichen planus.
  • Subject has a clinical lesion score of at least 2.
  • If female of childbearing potential, subject will have a negative urine pregnancy test at screening and week 0.
  • If female, subject will be either post-menopausal for > 1 year; surgically sterile (hysterectomy or bilateral tubal ligation); or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, intrauterine device [IUD], diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects will continue to use contraception for 3 months following the last injection.
  • Subjects must be on stable doses of topical medications, such as corticosteroids, cyclosporine, and tacrolimus for the past 4 weeks.

Exclusion Criteria:

  • Patients with known hypersensitivity to Raptiva (efalizumab) or any of its components.
  • Pregnant or lactating women
  • Subject has evidence of a clinically significant, unstable or poorly controlled medical condition.
  • Subject has a chest X-ray consistent with an active infection or previous exposure to tuberculosis (TB) and/or a positive purified protein derivative test at screening (> 5 mm). (Subjects may participate if they are being actively treated in accordance with Centers for Disease Control [CDC] guidelines.)
  • Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This includes hepatitis B and C, and HIV.
  • Subject has been hospitalized for infection or received intravenous (IV) antibiotics within the previous 2 months prior to baseline.
  • Subject has a history of tuberculosis without documented adequate therapy.
  • Subject has been diagnosed with a malignancy within the past 5 years except for successfully treated non-melanoma skin cancer.
  • Subject has any dermatologic disease in the target site that may be exacerbated by treatment or interfere with examination.
  • Subject has been administered an investigational drug in another clinical study within 30 days prior to baseline (or 5 half-lives, whichever is longer). Subjects in observational studies without investigational drugs or devices may still be enrolled.
  • Subject has used the following systemic agents within 4 weeks prior to week 0: photochemotherapy, systemic corticosteroids, cyclosporine, tacrolimus, azathioprine, methotrexate, mycophenolate mofetil, hydroxychloroquine, chloroquine, quinacrine, dapsone, or thalidomide.
  • Subject has previously been treated with biologic immune response modifiers including alefacept, etanercept, infliximab, or adalimumab within 12 weeks prior to day 0 (or 5 half-lives, whichever is longer).
  • Subject has previously been treated with efalizumab.
  • Subject weighs over 125 kg.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00133107

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Genentech
Investigators
Principal Investigator: Michael P. Heffernan, MD Washington University School of Medicine
  More Information

Study ID Numbers: LP-efalizumab
Study First Received: August 19, 2005
Last Updated: August 21, 2008
ClinicalTrials.gov Identifier: NCT00133107  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Mouth Diseases
Lichen Planus
Exanthema
Skin Diseases
Oral lichen planus
Stomatognathic Diseases
Skin Diseases, Papulosquamous
Lichen Planus, Oral

Additional relevant MeSH terms:
Lichenoid Eruptions

ClinicalTrials.gov processed this record on January 14, 2009