EUCTR2021-003050-23-SK招募中1 期
A Phase 2, Multicenter, Randomized, Double-Blind,Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects with Moderately to Severely Active Ulcerative Colitis
Oppilan Pharma Ltd., wholy owned subsidiary of Ventyx Biosciences Inc.0 个研究点目标入组 180 人开始时间: 2022年11月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men or women, 18 to 80 years of age, inclusive, at the time of consent.
- •2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
- •3. Diagnosed with UC = 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence. The endoscopy and histology report should be present in the source documents; however, if not available, the Screening endoscopy and histology may serve as such.
- •4. Active UC confirmed by endoscopy with = 10 cm rectal involvement. Participants with proctitis only at baseline who meet the other eligibility criteria for inclusion, including the endoscopic and rectal bleeding criteria for moderate to severe disease, will be capped at 10% of the total participants enrolled.
- •5. Moderately to severely active UC, defined as an MMS 5 to 9, including an endoscopic subscore (ES) = 2 and a rectal bleeding (RB) subscore = 1.
- •6. Surveillance colonoscopy (performed according to local standard) within 12 months before baseline to rule out dysplasia in participants with pancolitis > 8 years duration or participants with left sided colitis > 12 years duration. Participants without a surveillance colonoscopy within the prior 12 months will have a colonoscopy at Screening (ie, in place of Screening proctosigmoidoscopy). Any adenomatous polyps must be removed per local standard of care prior to the first dose of study drug.
- •7. Demonstrated inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies:
- •a. Conventional therapy:
- •i. Oral 5-aminosalicylic acid (5 ASA) compounds
- •ii. Corticosteroids
- •iii. Thiopurines (eg, azathioprine or 6 mercaptopurine)
- •b.Biologic therapy or JAK inhibitor therapy:
- •i. Anti-tumor necrosis factor alpha (TNFa) antibodies (eg, infliximab, adalimumab, or golimumab)
- •ii. Anti interleukin (anti-IL)12/23 (eg, ustekinumab)
- •iii. Anti integrin antibodies (eg, vedolizumab)
- •iv. JAK inhibitors (eg, tofacitinib, upadacitinib)
- •8. Adequate hepatic function, defined as a total bilirubin level of = 1.5 × upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels of = 2.0 × ULN. Participants with Gilbert’s syndrome who have an isolated total bilirubin and normal AST and ALT levels may participate.
- •9. Adequate renal function, defined as an estimated glomerular filtration rate = 60 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation at Screening
- •Inclusion criteria No.: 10- 11 can be found in study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 167
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Inflammatory Bowel Disease and Gastrointestinal Conditions
- •1. Severe extensive colitis as evidenced by:
- •a. Physician judgment that the participant is likely to require surgery (surgical intervention of any kind for UC [eg, colectomy]) within 12 weeks of baseline.
- •b. Current evidence of fulminant colitis or toxic megacolon, or recent history (within last 6 months) of toxic megacolon or bowel perforation.
- •c. Previous total colectomy.
- •2. Diagnosis of Crohn’s disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn’s disease.
- •3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.
- •4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile at Screening. Note: If C. difficile or pathogen test is positive, the subject may be treated and retested = 4 weeks after completing treatment.
- •5. Pregnancy, lactation, or a positive serum ß hCG measured during Screening.
- •6. Clinically relevant hematologic, hepatic, neurological, pulmonary, ophthalmological, endocrine, metabolic (including, but not limited to, hypo- and hyperkalemia), psychiatric, or other major systemic disease that will make implementation of the protocol or interpretation of the study difficult or will put the participant at risk.
- •7. Forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 70% of predicted values and FEV1/FVC ratio < 0.70 at Screening.
- •8. Have any of the following conditions or receiving treatments that may affect cardiovascular function:
- •a. Myocardial infarction, unstable angina, stroke/transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure within = 6 months prior to or during the Screening Period.
- •b. Screening or prerandomization vital signs (taken in the sitting position) with a heart rate (HR) < 50 bpm OR systolic blood pressure (BP) < 90 mmHg OR diastolic BP < 55 mmHg. Vital signs may be repeated up to 3 times during a visit to confirm abnormal readings.
- •c. Screening or prerandomization electrocardiogram (ECG) with PR interval > 200 msec or Fridericia’s corrected QT interval (QTcF) = 450 msec in men or = 470 msec in women
- •d. History of any of the following unless treated with an implanted pacemaker or an implanted cardioverter defibrillator with pacing:
- •i. History or presence of recurrent symptomatic bradycardia
- •ii. Second or third degree atrioventricular block
- •iii. Periods of asystole > 3 seconds
- •iv. History of sick sinus syndrome or recurrent cardiogenic syncope
- •e. Start, stop, or change in dosage of any Class I-IV anti-arrhythmic drugs = 1 week prior to dose titration starting at randomization and up to 1 week after titration to the assigned dose. This criterion also applies to the OLE Treatment Period titration: 1 week prior to and 1 week after the dose titration period.
- •9. Uncontrolled diabetes as determined by hemoglobin A1c (HbA1c) > 9%, or participants with diabetes with significant comorbid conditions, such as retinopathy.
- •10. History or presence of macular edema or retinopathy.
- •11. History of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved) or precancerous conditions such as colonic mucosal dysplasia, cervical dysplasia, and cervical intraepithelial neoplasia.
- •12. History of lymphoproliferative disorder, ly
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