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Safety and Effectiveness of Efalizumab to Treat Oral Lichen Planus

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00133107
First received: August 19, 2005
Last updated: August 18, 2011
Last verified: August 2011
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center, Open-label, Pilot Study Evaluating the Safety and Effectiveness of Subcutaneous Efalizumab in the Treatment of Oral Lichen Planus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • primary efficacy measure will be oral mucosal surface area involvement [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    area of oral mucosa involvement was measured in cm2 at baseline, week 4, week 8, week 12 and week 20. the primary efficacy outcome measure was the change in oral mucosal involvement at week 12.


Secondary Outcome Measures:
  • clinical lesion score [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]
    a numerical score from 0 to 5 where 0 = no lesion; 1 = white striae only; 2 = white striae and erosion < 1 cm; 3 = white striae and erosion > 1 cm; 4 = white striae and ulceration < 1 cm; 5 = white striae and ulceration > 1 cm

  • ten centimeter visual analogue pain scale [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]
    Patients were asked to put an X on a 10 cm line that corresponded to their degree of pain where 0 cm represented no pain and 10 cm represented the most severe pain

  • oral health impact profile-14 questionnaire [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]
    The OHIP-14 is a validated measure of the negative impact of oral disease on an individual's well being. The impact of various oral problems are rated from "never" to "very often," which correlates to a score of 0 to 4. The responses are weighted and summated giving a maximum score of 56 and a minimum score of 0.

  • cutaneous surface area involvement [ Time Frame: Week 0, 1, 4, 8, 12, and 20 ] [ Designated as safety issue: No ]
    The area of cutaneous disease involvement was measured in cm2


Enrollment: 4
Study Start Date: January 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
Investigators
Principal Investigator: Michael P. Heffernan, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Michael P.Heffernan, MD, Washington University
ClinicalTrials.gov Identifier: NCT00133107     History of Changes
Other Study ID Numbers: LP-efalizumab
Study First Received: August 19, 2005
Last Updated: August 18, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Mouth Diseases
Skin Diseases
Skin Diseases, Papulosquamous
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 24, 2014