EUCTR2006-006543-31-GB进行中（未招募）1 期
A Double-Masked, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Ranging Study with an Optional Extension 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 335 人开始时间: 2007年3月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 335
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
入选标准
- •Subjects with a documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or pan-uveitis
- •Uncontrolled uveitis, as evidenced by Grade 2+ or higher vitreous haze, in at least one eye for = 2 weeks prior to randomization.
- •Current uveitis therapy must conform to one of the following:
- •Prednisone monotherapy at a dose of = 10 mg/day (or equivalent) for = 2 weeks prior to randomization
- •Have received = 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
- •Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
- •Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
- •Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy
- •Considered by the Investigator to require immunomodulatory therapy
- •Subjects do not plan to undergo elective ocular surgery (e.g., cataract extraction) during the study
- •A minimum ability to count fingers at a distance of 30 cm (1 foot) using the study eye
- •At least 18 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) and throughout the extension phase
- •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:
- •Be over the age of 60 years
- •Be amenorrheic for at least 2 years if age 45-60 years
- •Have had a hysterectomy and/or bilateral oophorectomy
- •All other female subjects (including those with tubal ligations) will be considered to be of childbearing potential
- •Subjects must weigh 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)
- •Able to comply with the study requirements
- •Are the trial subjects under 18? no
- •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
- •Primary diagnosis of anterior uveitis
- •Uncontrolled glaucoma as evidenced by an intraocular pressure of >21 mmHg while on medical therapy
- •Subjects with chronic hypotony (less than 6 mmHg)
- •Any implantable corticosteroid-eluting device (e.g., 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 30 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 inhibitors, Section 9.8)
- •Subjects who have taken any other medications listed in Section 9.8, within the timeframe specified, prior to the first dose
- •Presence of an ocular toxoplasmosis scar
- •Recipients of a solid organ transplant
- •Subjects with lens opacities or obscured ocular media upon enrollment such that reliable evaluations and grading of the posterior segment cannot be performed
- •Subjects with a known history or clinical diagnosis of herpes zoster or varicella infection within 6 weeks before enrollment or chicken pox exposure within 21 days before enrollment
- •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)
- •Subjects who have a history of or exposure to syphilis or Lyme disease
- •Modification of Diet in Renal Disease Study (MDRD) glomerular filtration rate (GFR) < 60 mL/min
- •Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl transferase (GGT) =3x upper limit of normal
- •Severe anemia (hemoglobin < 6 g/dL), leukopenia (white blood cell count <2500/mm3), thrombocytopenia (platelet count < 80,000/mm3), polycythemia (hematocrit > 54% [male] or hematocrit > 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 or any of its components (vitamin E, medium chain triglyceride [MCT] oil, polysorbate 40, ethanol)
- •Using a therapy that would likely affect immune responses or interfere with trial logistics
- •Participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent
- •Subjects with any non-ocular, medically significant co-morbid conditions that impa
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