EUCTR2006-006545-13-DE进行中（未招募）不适用
A Double-Masked, Placebo-Controlled, Multi-Centre, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Uveitis.
ux Biosciences GmbH0 个研究点目标入组 100 人开始时间: 2007年1月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A documented history of non-infectious anterior, anterior and intermediate or panuveitis. Subjects are anticipated to have, but are not restricted to, the following conditions: intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal vasculitis, sympathetic ophthalmia and multifocal choroiditis with panuveitis.
- •Currently uncontrolled uveitis for a minimum of 2 weeks despite use of oral and/or topical corticosteroid or subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response are eligible for inclusion or subjects with uncontrolled uveitis for whom oral corticosteroid is contraindicated.
- •Subject has Grade 2+ or higher for anterior chamber cells at the time of enrollment.
- •Subjects are considered by the investigator to require corticosteroid-sparing therapy. Reasons may include but are not limited to such considerations as exacerbation of previously controlled disease, need for steroid-sparing therapy, corticosteroid-intolerance, history of diabetes, adverse experiences with current therapy or conditions for which immunosuppressive therapy is used typically.
- •The subject does not plan to undergo elective ocular surgery (e.g., cataract extraction) during the course of the study.
- •The subject, whether male or female, with reproductive potential and who is sexually active agrees to use double-barrier contraception methods throughout the course of the study (minimum of 24 weeks).
- •Women of childbearing potential must have a negative serum pregnancy test
- •within 48 hours prior to starting study drug.
- •Subject weighs at least 38 kg (84 lbs) and no more than 129 kg (284 lbs).
- •(Note: this restriction is imposed to allow for the masking of treatment
- •assignments.)
- •Subjects or their guardians must be capable of understanding the purpose and risks of the study; able to give informed consent (and assent by pediatric subjects, if required) and to comply with the study requirements.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age less than 13 years.
- •Uveitis of infectious etiology.
- •Clinically suspected or confirmed central nervous system or ocular lymphoma.
- •Treatment with an immune suppression regimen that includes an alkylating
- •agent within the previous 90 days.
- •Subjects who have received treatment with a monoclonal antibody or any other biologic therapy within the previous 90 days or alemtuzumab within the previous 12 months.
- •Presence of an ocular toxoplasmosis scar.
- •History of herpes zoster or varicella infection within 6 weeks prior to enrollment, or chicken pox exposure within 21 days before enrollment.
- •Seropositivity for human immunodeficiency virus (HIV).
- •Alanine transaminase (ALT), aspartate transaminase (AST), or gammaglutamyl
- •transferase (GGT) = 3x upper limit of normal (ULN).
- •Previous exposure or known contraindication to administration of LX211 (ISA247) or any of its components.
- •Recipients of a solid organ transplant.
- •History of clinically defined allergy to any of the constituents of the LX211 formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol).
- •Currently enrolled in another clinical therapeutic trial or who have received any investigational therapy within the 30 days prior to enrollment.
- •Using a therapy for a condition other than uveitis that would likely affect immune responses or interfere with trial logistics.
- •Currently pregnant or lactating.
- •Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the presence of active hepatitis B or C.
- •MDRD GFR < 60 mL/min
- •Severe anemia (hemoglobin < 6 g/dL), leukopenia (WBC < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3), polycythemia (Hct > 54%
- •[male] or Hct > 49% [female]) or clinically significant coagulopathy.
- •Current malignancy or a history of malignancy (within the previous 5 years) except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully.
- •Any non-ocular co-morbid condition that would require immunosuppression or
- •that would likely have an impact on the subject’s ability to comply with the study visit schedule.
- •Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication.
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