CTRI/2023/03/050181进行中（未招募）2 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 a wholly owned subsidiary of Ventyx Biosciences Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •(1) Diagnosed with UC = 3 months prior to Screening. The diagnosis of UC must be confirmed
- •by endoscopic and histologic evidence.
- •(2) Active UC confirmed by endoscopy with = 10 cm rectal involvement.
- •Moderately to severely active UC, defined as an MMS of 5 to 9, including an ES = 2 and an
- •RB subscore = 1
- •(3) Surveillance colonoscopy within 12 months before baseline or at screening to rule out dysplasia, pancolitis, left-sided colitis. Any adenomatous polyps must be removed prior to the first dose of study drug.
- •(4) Demonstrated inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies: Conventional therapy, Oral 5-ASA compounds, Corticosteroids, Thiopurines, Biologic therapy/ JAK inhibitor therapy, TNFa antibodies, Anti-interleukin (anti-IL)12/23, Anti-integrin antibodies,
- •(5) Adequate hepatic function
- •(6) Adequate renal function, with estimated glomerular filtration rate = 60 mL/min/1.73 m2 at Screening
- •(7) Patients are permitted to receive the following concomitant medications:
- •a.Oral 5-ASA compounds at a stable dose or discontinued for = 2 weeks prior to Screening
- •b.Oral corticosteroid therapy at a stable dose or discontinued for = 2 weeks prior to Screening endoscopy
- •c.Probiotics, provided the dose has been stable for = 2 weeks prior to Screening endoscopy
排除标准
- •1. Severe extensive colitis as evidenced by:
- •a. Physician judgment that the patient is likely to require surgical intervention of any kind for UC within 12 weeks of baseline.
- •b. Current evidence of fulminant colitis or toxic megacolon, or recent history of toxic megacolon or bowel perforation
- •c. Previous total colectomy
- •2. Diagnosis of Crohn’s disease or indeterminate colitis.
- •3. Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
- •4. Positive assay or stool culture for pathogens or positive test for Clostridium difficile toxin at Screening.
- •5. Pregnancy, lactation, or a positive serum ß-hCG measured during Screening
- •6. Clinically relevant hematologic, hepatic, neurological, pulmonary, ophthalmological, endocrine, metabolic, psychiatric, or other major systemic disease that will make implementation of the protocol or interpretation of the study difficult or will put the patient 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
- •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 pre-randomization vital signs taken in the sitting position with a HR < 50 bpm
- •OR systolic BP < 90 mmHg OR diastolic BP < 55 mmHg.
- •c. Screening or pre-randomization 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 animplanted cardioverter-defibrillator with pacing:
- •i. History or presence of recurrent symptomatic bradycardia
- •ii. Second- or third-degree AV 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 patients 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 or precancerous conditions such as colonic mucosal dysplasia, cervical dysplasia, and cervical intraepithelial neoplasia
- •12. History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder,
- •or multiple myeloma
- •13. History of alcohol or drug abuse within 1 year prior to randomization
- •14 . Active or latent TB infection at Screening. History of untreated or inadequately treated latent
- •TB infection. The following are EXCEPTIONS to this exclusion criterion:
- •a. Patients with latent TB, who have been ruled out for active TB, have completed an
- •appropriate
研究者
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