A Multicenter, Open-label, Single-arm Study to Demonstrate the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Chinese Subjects Requiring High Dose Corticosteroids for Active Non-Infectious Intermediate-, Posterior-, or Pan-uveitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 7
- 主要终点
- Percentage of participants that achieve quiescence in both eyes
研究概览
简要总结
Non-infectious intermediate-, posterior- and pan-uveitis (NIIPPU) are sight threatening diseases with a high patient burden and negative impact on quality of life. Corticosteroids remain the mainstay of first-line treatment for NIIPPU in China despite serious side effects associated with long-term and high-dose corticosteroid use. Adalimumab is used to treat NIIPPU in adults who have had inadequate response to corticosteroids, or who need corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. The purpose of this study is to assess adverse events and effectiveness of adalimumab in Chinese participants requiring high dose corticosteroids with NIIPPU.
Adalimumab is a conditionally approved drug in China used to treat participants with NIIPPU. All participants will receive the same treatment. Approximately 87 adult participants will be enrolled at approximately 15 sites in China.
Participants will receive one subcutaneous loading dose of adalimumab at baseline followed a week later by a lower dose of adalimumab every other week for up to 30 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
入选标准
- •Male or female of Chinese descent, with full Chinese parentage.
- •Diagnosed with active non-infectious intermediate uveitis, posterior uveitis, or panuveitis defined by the presence of at least 1 of the following in at least one eye:
- •Active, inflammatory chorioretinal, and/or inflammatory retinal vascular lesion
- •≥ 2+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria); or
- •≥ 2+ vitreous haze (National Eye Institute [NEI]/SUN criteria).
- •Receiving oral prednisone from ≥ 10mg/day to ≤ 60mg/day (or oral corticosteroids equivalent) for at least two weeks before Screening and remaining on the same dose from Screening to Baseline.
排除标准
- •Participants with the following ocular events:
- •Isolated anterior uveitis;
- •Confirmed or suspected infectious uveitis;
- •Ocular masquerade syndromes, such as ocular lymphoma;
- •Presumed ocular histoplasmosis syndrome;
- •Serpiginous choroidopathy;
- •Scleritis;
- •Corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial;
- •Macular edema as the only sign of uveitis;
- •Severe VH that precludes visualization of the fundus at the baseline visit;
- •Intraocular pressure of ≥ 25 mmHg and on ≥ 2 glaucoma medications or evidence of glaucomatous optic nerve injury;
- •Best Corrected Visual Acuity less than 20 letters Early Treatment Diabetic Retinopathy Study (ETDRS) in either eye at the Baseline visit;
- •Proliferative or severe non-proliferative diabetic retinopathy or clinically significant macular edema due to diabetic retinopathy;
- •Neovascular/wet age-related macular degeneration;
- •Abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process.
- •Ocular surgery within 90 days prior to the Baseline visit with the exception of refractive laser surgery or retinal laser photocoagulation or YAG (neodymium-doped yttrium aluminium garnet) posterior capsulotomy. These three exceptions are exclusionary within 30 days prior to Baseline.
- •Previous exposure to anti-a TNF therapy inhibitor or any biologic therapy with a potential therapeutic impact on non-infectious uveitis and discontinued for reasons other than lack of efficacy or intolerance (e.g., change of insurance) is allowed after completing the specified wash-out period prior to the Baseline visit. Participants who have had lack of efficacy or intolerance to TNF inhibitors (including Humira and its biosimilars) are not eligible.
- •Has received glucocorticosteroid implant, Ozurdex® (dexamethasone implant), or intravitreal adalimumab, Methotrexate (MTX) or anti-VEGF therapy at any time prior to the Baseline visit. For those with previous exposure of anti-VEGF therapy, participants must complete the specified wash-out period prior to the baseline visit.
- •Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the Baseline visit.
- •Participant has been receiving cyclophosphamide within 30 days and initiated new cyclophosphamide treatment within 30 days prior to the Baseline visit.
- •Participant treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
- •Participant received any live vaccine with replicating potential within 28 days prior to the first dose of study drug, or expected need of live vaccination with any live vaccine with replicating potential during study participation including at least 70 days after the last dose of study drug. Live vaccines that are incapable of replicating (e.g., JYNNEOS monkeypox vaccine or Convidecia or Convidecia Air COVID-19 vaccines) are permitted.
- •Participant treated with oral traditional Chinese medicine (described for the treatment of UV) within 14 day prior to the first dose of study drug.
研究组 & 干预措施
Adalimumab
Participants will receive a loading dose of Adalimumab 80mg SC at Baseline followed a week later by a dose of Adalimumab 40mg SC every other week.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of participants that achieve quiescence in both eyes
时间窗: Week 30
Quiescence is defined as no active inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤ 0.5+
次要结局
- Percentage of participants that achieve no active lesions in both eyes(Week 30)
- Percentage of participants that achieve Anterior Chamber (AC) cell grade ≤ 0.5+ in both eyes(Week 30)
- Percentage of participants that achieve Vitreous Haze (VH) grade ≤ 0.5+ in both eyes(Week 30)
- Percentage of participants that achieve no worsening of Best Corrected Visual Acuity (BCVA) by ≥ 15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes(Week 30)
- Percentage of participants that achieve a ≥ 50% reduction in immunosuppression load(Week 30)
- Percentage of participants that achieve a systemic corticosteriods dose ≤ 7.5 mg(Week 30)