EUCTR2006-006544-66-AT进行中（未招募）不适用
A Double-Masked, Placebo-Controlled, Multi-Centre, Parallel Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Clinically Quiescent Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis.
ux Biosciences GmbH0 个研究点目标入组 350 人开始时间: 2007年4月27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
- 350
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 diagnosis of non-infectious intermediate-, anterior and intermediateposterior-
- •or pan- uveitis of at least three months duration prior to enrollment, requiring treatment during that period to control intraocular inflammatory disease and avoid sight-threatening complications due to inflammation. 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
- •Minimum prescribed therapy upon enrollment is either a dose averaging = 10 mg/day of systemic prednisone or equivalent or a more intensive immunosuppression regimen (e.g. corticosteroid combined with a
- •corticosteroid-sparing agent) and/or repeated periocular/intravitreal corticosteroid administration (i.e. = 2 administrations within the previous 6 months) for control of inflammatory disease. More intensive regimens may include one additional immunosuppressive drug from among the following (or related) compounds:
- •- cyclosporine
- •- tacrolimus
- •- azathioprine
- •- mycophenolate mofetil
- •- methotrexate
- •Subjects who are intolerant of local corticosteroid therapy due to the
- •development of an ocular hypertensive episode
- •Subjects may also enter the study if they are receiving treatment with topical
- •corticosteroids for control of anterior inflammation
- •Subjects may also enter the study if they are receiving treatment with a single
- •immunomodulatory drug for uveitis control
- •The subject’s uveitis is considered clinically quiescent on current medications
- •at the time of enrollment. Clinical quiescence means that the prescribed
- •dosage(s) for their current uveitis medications at enrollment have neither
- •been increased in the 6 weeks prior to enrollment, nor there have been any
- •symptoms, signs or history of exacerbation of intraocular inflammation during
- •this same 6-week period
- •Subjects are considered by the investigator to require corticosteroid-sparing
- •therapy. Reasons may include such considerations as need for steroidsparing
- •therapy, corticosteroid-intolerance, history of diabetes, adverse experiences with current therapy or conditions for which immunosuppressive therapy is used typically (e.g. posterior uveitides, birdshot retinochoroidopathy, multifocal choroiditis with panuveitis)
- •Subjects have BCVA in the worst involved eye of 20/400 or better (ETDRS
- •logMAR < 1.34)
- •Subjects do not plan to undergo elective ocular surgery (e.g., cataract
- •extraction) during the course of the study
- •At least 13 years of age
- •Subjects, whether male or female, with reproductive potential and who are
- •sexually active agree to use double-barrier contraception methods throughout
- •the course of the study (minimum of 26 weeks)
- •Women of childbearing potential must have a negative urine pregnancy test
- •(UPT) within 48 hours prior to starting study drug and must not be lactating
- •Female subjects of non-childbearing potential must meet at least one of the
- •following criteria:
- •1. Postmenopausal females, defined as:
- •a. Females over the age of 60 years.
- •b. Females who are 45 to 60 years of age must be
- •amenorrheic for at least 2 years.
- •2. Females who had a hysterectomy and/or bilateral oophorectomy.
- •All other female subjects (including females with tubal ligations) will be
- •considered to be of childbearing potential.
- •Subjects weigh at least 38 kg (84 lbs) and no more than 11
排除标准
- •Uveitis of infectious etiology
- •Clinically suspected or confirmed central nervous system or ocular lymphoma
- •A primary diagnosis of anterior uveitis
- •Evidence of active, uncontrolled non-infectious uveitis
- •Uncontrolled glaucoma
- •A history or diagnosis of Behçet’s disease (since tapering or withdrawal of concomitant immunosuppressive medications is not a usual standard-of-care
- •for Behçet’s subjects)
- •Local (periocular/intravitreal) administration of corticosteroids within the
- •previous 6 weeks
- •Any implantable corticosteroid-eluting device (eg, Retisert™, Posurdex®,
- •Medidur™, I-vation™ TA intravitreal implant)
- •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 with alemtuzumab within
- •the previous 12 months
- •Subjects who have used any drugs or substances known to be strong
- •inhibitors of CYP 3A4/5 enzymes within 7 days of the first dose, or grapefruit
- •juice and star fruit within 24 hours of the first dose (listed in table of CYP
- •3A4/5, Section 9.7)
- •Subjects who have taken any other medications listed in Section 9.7, within
- •the timeframe specified, prior to the first dose
- •Recipients of a solid organ transplant
- •Subjects with chronic hypotony (less than 6 mmHg)
- •Subjects with lens opacities or obscured ocular media upon enrollment such
- •that reliable evaluation and grading of the posterior segment cannot be
- •Presence of an ocular toxoplasmosis scar
- •A known history or clinical diagnosis of herpes zoster or varicella infection
- •within 6 weeks prior to enrollment, or chicken pox exposure within 21 days
- •before enrollment
- •Subjects with diabetes mellitus that is inadequately controlled
- •Active, extraocular infection requiring the prolonged or chronic use of
- •antimicrobial agents or the presence of active hepatitis A, B or C virus (HAV,
- •Subjects who have a history of or exposure to syphilis, Lyme , or
- •toxoplasmosis
- •Modification of Diet in Renal Disease Study (MDRD) glomerular filtration rate
- •(GFR) < 60 mL/min
- •Alanine transaminase (ALT), aspartate transaminase (AST), or gammaglutamyl
- •transferase (GGT) = 3x upper limit of normal (ULN)
- •Severe anemia (hemoglobin < 6 g/dL), leukopenia (white blood cell count[WBC] < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3),
- •polycythemia (hematocrit [Hct] > 54% [male] or Hct > 49% [female]) or
- •clinically significant coagulopathy
- •Seropositivity for human immunodeficiency virus (HIV)
- •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
- •Previous exposure or known contraindication to administration of LX211
- •(ISA247) or any of its components
- •History of clinically defined allergy to any of the constituents of the LX211
- •formulation (vitamin E, medium chain triglyceride [MCT] oil, Tween 40,
- 另有 7 项未显示
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