EUCTR2006-006543-31-AT进行中（未招募）不适用
A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study to Assess the Efficacy and Safety of LX211 as Therapy in Subjects with Active Sight Threatening, Non-Infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis.
ux Biosciences GmbH0 个研究点目标入组 325 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
- 325
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 intermediate-, anterior and intermediate-, posterior- 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 on prednisone monotherapy at a dose of =10 mg/day (or equivalent) or despite having received =2 injections of corticosteroid (intravitreal or periocular) for control of disease within the previous six months or subjects for whom oral corticosteroid is contraindicated.
- •Subjects who are intolerant of local corticosteroid therapy due to the development of an ocular hypertensive response.
- •Grade 2+ or higher for vitreous haze 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 (e.g. posterior uveitides, birdshot retinochoroidopathy, multifocal choroiditis with panuveitis).
- •The subject does 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 24 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.
- •Subject weighs at least 38 kg (84 lbs) and no more than 110 kg (242 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
- •Uveitis of infectious etiology.
- •Clinically suspected or confirmed central nervous system or ocular lymphoma.
- •Any implantable corticosteroid-eluting device (eg, Retisert™, Posurdex®,
- •Medidur™, I-vation™ TA intravitreal implant).
- •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.
- •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 9.8).
- •Subjects who have taken any other medications listed in Section 9.8, within
- •the timeframe specified, prior to the first dose.
- •Primary diagnosis of anterior uveitis.
- •Uncontrolled glaucoma.
- •Presence of an ocular toxoplasmosis scar.
- •Lens opacities or obscured ocular media upon enrollment such that reliable evaluation and grading of the posterior segment cannot be performed.
- •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.
- •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.
- •Subjects with chronic hypotony (less than 6 mmHg)
- •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 and/or has
- •not recovered from any reversible effects or side effects of prior
- •investigational agent.
- •Using a therapy for a condition other than uveitis that would likely affect immune responses or interfere with trial logistics.
- •Active, extraocular infection requiring the prolonged or chronic use of antimicrobial agents or the presence of active hepatitis A, B or C virus (HAV, HBV, HCV).
- •Modification of Diet in Renal Disease Study (MDRD) glomerular filtration rate (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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