EUCTR2016-003452-75-LV进行中（未招募）1 期
A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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 subjects aged 18 to 80 years, inclusive.
- •2. Diagnosis of UC for = 2 months prior to screening, with a history of disease activity extending beyond the rectum; if the UC has been present for > 10 years, a total colonoscopy with biopsy must have been performed within 2 years of screening to rule out dysplasia. Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age > 50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance per local standards and guidelines (may be performed during screening). Subjects with extensive colitis or pancolitis of > 8 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial Screening visit (may be performed during screening).
- •3. Moderate to severe active UC as defined by complete Mayo Score of 6 to 12, inclusive (range 0 to 12), at baseline (pre-randomisation) with endoscopy score of at least 2 (range 0 to 3), extending 15 cm or more from the anal verge, as determined by blinded central read, within 14 days of randomisation.
- •4. Demonstrated, over the previous 5-year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
- •a. Immunomodulators
- •i. Signs and symptoms of persistently active disease despite a history of at least one = 8-week regimen of oral azathioprine (= 1.5 mg/kg) or 6-mercaptopurine (6-MP) (= 0.75 mg/kg), OR
- •ii. History of intolerance of at least 1 immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopaenia, thiopurine S-methyltransferase genetic mutation, and/or infection)
- •b. TNF-a antagonists
- •i. Signs and symptoms of persistently active disease despite a history of at least 1 induction regimen of at least 6 weeks duration, OR
- •ii. Recurrence of symptoms during maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not qualify), OR
- •iii. History of intolerance (including, but not limited to, infusion- or injection-related reaction, demyelination, congestive heart failure, and infection)
- •Note: A maximum of 50% of randomised subjects may have had prior treatment with TNF-a antagonists. For subjects in the Netherlands, only
- •subjects who have had prior exposure to anti TNF agents will be allowed
- •to enrol in the study (as confirmed by medical record documentation or
- •by self reporting).
- •c. Corticosteroids
- •i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone 30 mg daily orally for 2 weeks or intravenous (IV) for 1 week, OR
- •ii. Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally on 2 separate occasions, OR
- •iii. History of intolerance of corticosteroids (including, but not limited to, Cushing’s syndrome, osteopaenia/osteoporosis, hyperglycaemia, insomnia, and infection).
- •5. Subject is unlikely to conceive, as indicated by at least one yes” answer to the following criteria:
- •a. Subject is a male
- •b. Subject is a surgically sterilised female (at least 90 days prior to Screening)
- •c. Subject is a post-menopausal female = 45 years of age with > 1 year since last menses; if a female subject is < 45 years of age, or cessation of menses is < 1 year and > 6 months, follicle-stimulating h
排除标准
- •1. Subject with Crohn's disease (CD), indeterminate colitis, or presence or history of fistula consistent with CD.
- •2. History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history of extensive colonic resection, or subtotal or total colectomy; or is at imminent risk of colectomy.
- •3. History or current evidence of colonic dysplasia or adenomatous colonic polyps. Note: Subjects will not be excluded from the study because of a pathology finding of indefinite dysplasia with reactive atypia. Subjects with resected adenomatous polyps may be enrolled.
- •4. Current bacterial or parasitic pathogenic enteric infection, including Clostridium difficile, (confirmed by toxin result), current infection with hepatitis B or C virus, (subjects treated for HCV infection must have evidence of sustained virologic response 12 weeks after the end of treatment [SVR12], infection requiring hospitalisation or IV antimicrobial therapy, opportunistic infection within 6 months of dosing, any infection requiring antimicrobial therapy within 2 weeks of dosing, history of more than one episode of herpes zoster, history of infection with human immunodeficiency virus, (HIV), or any episode of disseminated zoster. Note: Subjects with a history of C. difficile infection treated with antibiotics with or without faecal microbial transplant may be rescreened after 2 weeks following completion of treatment.
- •5. Live virus vaccination within 1 month prior to screening.
- •6. Subject has a concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, haematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject by their participation in the study.
- •Note: Subjects with a history of uncomplicated kidney stones, childhood asthma, or concurrent stable and well-controlled asthma may be enrolled in the study at the discretion of the Investigator.
- •7. Known primary or secondary immunodeficiency.
- •8. History of myocardial infarction, unstable angina, transient ischaemic attack, decompensated heart failure requiring hospitalisation, congestive heart failure (New York Heart Association Class 3 or 4), uncontrolled arrhythmias, cardiac revascularisation, stroke, uncontrolled hypertension (systolic blood pressure [BP] > 160 mmHg or diastolic BP > 100 mmHg at Screening), or uncontrolled diabetes (haemoglobin A1c > 9% or > 1 episode of severe hypoglycaemia) within 6 months of screening.
- •9. Clinically meaningful laboratory abnormalities at Screening including,
- •but not limited to, the ranges below:
- •a. Absolute neutrophil count < 1000/µL
- •b. Platelet count < 100,000/µL
- •c. Haemoglobin < 9 g/dL
- •d. Creatinine = 1.5 mg/dL
- •e. alanine aminotransferase or aspartate aminotransferase = 2.5 x upper limit of normal (ULN) or bilirubin > 1.5 x ULN
- •10. Pregnant or lactating females.
- •11. Any surgical procedure requiring general anaesthesia within 1 month prior to screening, or planned elective surgery during the study.
- •12. History of malignant neoplasms or carcinoma in situ within 5 years prior to screening. (Subjects who are cancer-free for the previous 5 years may be enrolled. Subjects with adequately treated non-metastatic basal cell skin cancer, squamous cell skin cancer that has not recurred for at least 1 year prior to screening, or history of adequately trea
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