EUCTR2016-003452-75-PL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 mont
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 cluded 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 reated 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 ad
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