EUCTR2018-003349-41-DE进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis
Sublimity Therapeutics (Hold Co) Ltd.0 个研究点目标入组 380 人开始时间: 2018年12月19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
- 380
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
- •1. Male and female adult subjects 18 to 75 years old, inclusive.
- •2. Diagnosis of UC established at least 3 months prior to the Baseline visit, by clinical and endoscopic evidence (colonoscopy or flexible sigmoidoscopy).
- •3. Moderately to severely active UC defined as the 3-Component Adapted Mayo Score of 5-9, inclusive, with an endoscopic sub-score of = 2 (from central reading), and a rectal bleeding sub-score of = 1, as determined 10 days (± 3 days) prior to Baseline.
- •4. Evidence of active UC, confirmed histologically (from local read), extending proximal to the rectum with = 15 cm of involved colon.
- •5. At Screening, a colonoscopy will be required if the subject has had extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration but has not had a colonoscopy within 1 year of the initial screening date. If the subject has had a colonoscopy within 1 year of the initial screening date, a flexible sigmoidoscopy may be
- •6. Subjects presenting at Screening with moderately to severely active UC demonstrating an inadequate response or loss of response or intolerance/medical contraindication to at least one of the following conventional therapies for UC:
- •a. Corticosteroids
- •i. Signs and symptoms of active disease despite treatment with an adequate dose (e.g. prednisolone > 40 mg/day or equivalent) over a period of 4 weeks for oral therapy or IV for up to 1 week or = 9 mg/day oral budesonide;
- •ii. Unable to reduce corticosteroids below the equivalent of prednisolone 10 mg
- •daily orally within 3 months of starting steroids or experienced a relapse within 3 months of stopping steroids;
- •iii. History of, or current intolerance to corticosteroids (including, but not limited to Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection).
- •b. Immunomodulators
- •i. Signs and symptoms of active disease despite at least 3 months of treatment with a sufficient dose (oral azathioprine = 1.5 mg/kg or 6-MP = 0.75 mg/kg);
- •ii. History of, or current dose-limiting toxicity associated with use of the agent (e.g. but not limited to nausea/vomiting, abdominal pain, pancreatitis, LFT abnormalities, lymphopenia, TPMT genetic mutation, infection).
- •c. Anti-TNF agents
- •i. Signs and symptoms of active disease despite treatment with a single anti-TNF agent. Treatment failure is defined as a relapse after an initial response to therapy as follows:
- •Infliximab: At least 4 infusions of at least 5 mg/kg within a 14-week
- •timeframe for induction and maintenance;
- •Adalimumab: Induction regimen incorporating 160 mg at Week 0 (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) and 80 mg at Week 2, followed by maintenance treatment of 40 mg every other week up to at least Week 8;
- •Golimumab: Induction regimen incorporating 200 mg sc injection at Week 0, followed by 100 mg at Week 2 and then maintenance treatment of 50 mg or 100 mg (weight dependent) every 4 weeks after completion of the induction regimen up to at least Week 12;
- •ii. History of, or current intolerance (with an initial response), defined as the
- •presence of clinically significant side-effects, including infusion-related hypersensitivity.
- •d. Vedolizumab
- •i. Signs and symptoms of active disease despite a history of at least one induction regimen, defined as at least a 14-week (10 weeks in the EU) induction consisting of 300 mg IV at Weeks 0, 2 and 6.
- •ii. History of intolerance t
排除标准
- •1. Subjects without previous treatment for UC.
- •2. Ulcerative colitis limited to rectum (ulcerative proctitis).
- •3. Evidence of acute severe colitis with toxic megacolon, abdominal abscess, bowel stricture or bowel perforation.
- •4.A diagnosis of Crohn’s colitis, colitis yet to be classified, ischemic colitis, non-steroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with UC) or radiation colitis.
- •5. Subjects with evidence of pathogenic bowel infection (Clostridium difficile, Escheria coli, Salmonella, Shigella or Campylobacter).
- •6. Previous surgery for UC or, in the opinion of the Investigator, will likely require surgery for UC during the study.
- •7. Any histological evidence of mucosal dysplasia.
- •8. Any of the following laboratory abnormalities during the screening period – if values are initially outside the prescribed limits, the evaluation may be repeated once within the screening period to determine eligibility:
- •a. Hemoglobin level < 8.0 g/dL
- •b. Absolute WBC count < 3.0 × 10^9/L
- •c. Absolute Lymphocyte count < 0.5 × 10^9/L
- •d. Absolute neutrophil count < 1.2 × 10^9/L
- •e. Platelet count < 100 × 10^9/L or >1200 × 10^9/L
- •f. ALT or AST > 2.5 × ULN
- •g. Alkaline phosphatase > 2.5 × ULN
- •h. Serum creatinine > 1.5 × ULN
- •i. Bilirubin > 1.5 × ULN
- •9. Treatment with a biologic agent for UC within 56 days or 5 half-lives (whichever is greater) prior to the Baseline visit.
- •10. Treatment with any calcineurin inhibitor (e.g. cyclosporine or tacrolimus) within 28 days prior to the Baseline visit.
- •11. Treatment with methotrexate from the initial Screening visit until the end of the study.
- •12. Initiation of treatment with an oral or IV corticosteroid from the initial Screening visit until the end of the study.
- •13. Treatment with methotrexate or JAK inhibitors (e.g. tofacitinib) from the initial Screening visit until the end of the study
研究者
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