NCT00133107已完成不适用
A Single Center, Open-label, Pilot Study Evaluating the Safety and Effectiveness of Subcutaneous Efalizumab in the Treatment of Oral Lichen Planus
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- primary efficacy measure will be oral mucosal surface area involvement
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •If female of childbearing potential, subject will have a negative urine pregnancy test at screening and week
- •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.
排除标准
- •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.
结局指标
主要结局
primary efficacy measure will be oral mucosal surface area involvement
时间窗: 12 weeks
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.
次要结局
- clinical lesion score(Week 0, 1, 4, 8, 12, and 20)
- ten centimeter visual analogue pain scale(Week 0, 1, 4, 8, 12, and 20)
- oral health impact profile-14 questionnaire(Week 0, 1, 4, 8, 12, and 20)
- cutaneous surface area involvement(Week 0, 1, 4, 8, 12, and 20)
研究者
研究点 (2)
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