NCT03235752已完成2 期
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis
I-Mab Biopharma HongKong Limited26 个研究点 分布在 3 个国家目标入组 91 人开始时间: 2018年2月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 26
- 主要终点
- Clinical and endoscopy response
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase II study.
详细描述
is a multicenter, randomized, double-blind, placebo-controlled phase II study. The trial includes a Run-in Period (if stable conventional treatment needed), a 4-week Screening Period, a 12-week Treatment Period, and a 3-week Safety Follow-up Period to Day 105.
90 patients will be centrally, dynamically, randomly assigned to 3 groups (1:1:1) to receive 600mg TJ301 Q2W, 300mg TJ301 Q2W or placebo Q2W.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomized, Double-blind, Placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 18-70 (inclusive) years of age.
- •Hisory of active UC of more than 3 months. Active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy at Screening, with extending > 15-cm past the anal verge from endoscopy. Biopsy sample is not necessary if UC is already confirmed.
- •Active UC with a full Mayo score≥5 and a rectal bleeding subscore ≥1 at screening.
- •During Day -28 to Day -6 prior to Randomisation, an endoscopy subscore ≥
- •Treated with conventional non-biological UC therapy: with corticosteroids stable for at least 2 weeks prior to Randomization at no more than 20 mg prednisone per day (or equivalent), and/or with medications containing 5-aminosalicylates (5-ASA) at no less than 2 g 5-ASA per day for at least 3 months and stable for at least 4 weeks prior to Randomization, and/or with azathioprine (AZA) at no less than 0.75 mg/kg/day or mercaptopurine (6-MP) at no less than 0.5 mg/kg/day for at least 6 months and stable for at least 6 weeks prior to Randomization, or MTX no less than 12.5 mg/week and stable for at least 12 weeks prior to Randomization.
- •Male subjects and female subjects of child bearing potential must have been willing to practice effective contraception during the study and been willing and able to continue contraception for 1 month after their last dose of the study treatment.
- •The patient is able and willing to comply with the requirements of this trial protocol.
- •The subject should be able to read and write to understand and fill out Patient Diary.
- •Voluntarily signed Informed Consent obtained before any trial-related procedures are performed.
- •The subject have not received any biologic therapies OR have received 1 biologic drug for the treatment of UC or immune diseases and the last dose must be longer than 8-week or a 5 half-life (whichever is longer) period prior to the first dose of study drug.
排除标准
- •Pregnant or breastfeeding women.
- •Contraindication to colonoscopy or sigmoidoscopy.
- •Allergies to any component of TJ
- •Subject who is likely to receive surgery for UC treatment within 1 month based on investigator's evaluation.
- •History of colostomy, colectomy or partial colectomy.
- •Current diagnosis of inflammatory bowel disease unclassified, Crohn's disease, ischemic colitis, fulminant colitis and/or toxic megacolon, patients with ulcerative colitis limited to the rectum (ulcerative proctitis), infective enteritis, amebic bowel disease or intestinal schistosomiasis.
- •History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix. If the Screening colonoscopy shows evidence of dysplasia or a malignancy, the patient is not eligible.
- •Primary or secondary immunodeficiency including neutropenia (absolute neutrophil count <1500/μL); or lymphopenia (absolute lymphocyte count <500/μL).
- •Moderate to severe anaemia (haemoglobin <9 g/dL), or thrombocytopenia (platelet count <75 000/μL), or serum creatinine >2 mg/dL.
- •Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism.
- •Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4 weeks prior to Randomization.
- •serum transaminases >2.5 x upper limit of normal [ULN], alkaline phosphatase >2.5 x ULN.
- •Serious underlying disease other than UC in the opinion of the investigator.
- •History of drug addiction within the last 1 year or current drug addiction or use of illicit drugs.
- •Any indication of the regular use of more than 40 grams of alcohol every day.
- •Smokers who smoke more than 10 cigarettes per day.
- •Known concurrent acute or chronic viral hepatitis B or C infection or human immunodeficiency virus (HIV) infection.
- •Presence or history of active tuberculosis (TB) or latent TB infection, defined as 1) a positive QuantiFERON-TB Gold test at Screening; or 2) a T-spot test within 4 weeks of Randomisation and evidence of current or previous pulmonary tuberculosis by low-dose CT or chest X-ray within 12 weeks of Randomisation. Patients with old TB will also be excluded.
- •Positive immunoglobulin M antibody titres to Epstein-Barr virus (EBV).
- •Subjects with positive results for cytomegalovirus at screening are to be excluded.
- •Receiving any investigational therapy or any approved therapy for investigational use within 30 days or 5 half-lives prior to Randomization (whichever is longer).
- •Currently taking any medications other than those allowed per protocol guidelines.
- •Infections (including diverticulitis) requiring treatment with antibiotics, antivirals, or antifungals within 14 days prior to Randomisation.
- •Received any live (attenuated) vaccines within 30 days prior to Randomisation.
- •Recent treatment with medium-to-high-dose intravenous corticosteroids (methylprednisolone 60 mg/day or hydrocortisone 300 mg/day) within 8 weeks prior to Randomisation or oral corticosteroids of more than 20 mg prednisone per day (or equivalent).
- •Receipt of cyclosporine, tacrolimus, sirolimus, thalidomide, or mycophenolate mofetil within 30 days prior to Randomisation.
- •Treatment with therapeutic enema or suppository, other than required for endoscopy preparation, within 14 days prior to the screening endoscopy and during the remainder of the trial.
研究组 & 干预措施
TJ301 300mg
Experimental
TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.
干预措施: TJ301 300mg (Drug)
TJ301 600mg
Experimental
TJ301 300mg administrations will occur on Days 0, 14, 28, 42, 56, and 70.
干预措施: TJ301 600mg (Drug)
Placebo
Placebo Comparator
Placebo administrations will occur on Days 0, 14, 28, 42, 56, and 70.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical and endoscopy response
时间窗: Week 12
Clinical and endoscopy response (decrease from Baseline in full Mayo score ≥3 and ≥30%, including decrease from Baseline in rectal bleeding subscore ≥1 or rectal bleeding subscore ≤1) at Week 12.
次要结局
- Clinical and endoscopy remission at Week 12(Week 12.)
- Clinical remission at Weeks 4, 6, 8, 10, and 12(Weeks 4, 6, 8, 10, and 12)
研究者
研究点 (26)
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