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临床试验/EUCTR2015-001942-28-ES
EUCTR2015-001942-28-ES进行中（未招募）1 期

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis

Arena Pharmaceuticals, Inc.0 个研究点目标入组 240 人开始时间: 2015年10月5日最近更新:
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适应症

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
240
研究概览入排标准研究者记录与标识符相似试验

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. Men or women of age 18 to 80 years, inclusive
  • •2. Able to give signed informed consent
  • •3. Willing and able to comply with the study requirements
  • •4. Considered to be in stable health in the opinion of the investigator, as determined by:
  • •- A pre-study physical examination with no clinically significant abnormalities unrelated to ulcerative colitis
  • •- Vital signs (VS) at screening: pulse rate >= 55 bpm, systolic blood pressure (SBP) >= 90, and diastolic blood pressure (DBP) >= 55
  • •- Liver function tests (ALT/AST, bilirubin and alkaline phosphatase) <2X the upper limit of normal [ULN]
  • •- All other pre-study clinical laboratory findings within normal range, or if outside of the normal range are not deemed clinically significant in the opinion of the investigator
  • •- 12-lead electrocardiogram (ECG) showing no clinically significant abnormalities (for confirmation please refer to exclusion criteria n23)
  • •- A chest x-ray showing no evidence of active pulmonary disease (a chest x-ray taken within the previous 12 months from the screening visit may also be used)
  • •- Ophthalmology evaluation (by an ophthalmologist) without evidence of macular edema, supported with OCT where available (dependent on site capability)
  • •5. Diagnosis of ulcerative colitis established at least 6 months prior to screening by clinical and endoscopic evidence and corroborated by histopathology report.
  • •6. Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic score of 4 to 9 that includes an endoscopic subscore of >=2 and a rectal bleeding score of >=1 (using 3 of the 4 components of the complete Mayo Clinic score [endoscopic findings, rectal bleeding, and stool frequency]). These values will be obtained from patient diary entries of rectal bleeding and stool frequency within the 10 days prior to randomization and flexible proctosigmoidoscopy results as determined by a blinded central reader within 7 days prior to randomization
  • •7. Evidence of colonic ulcerative colitis activity on endoscopy (i.e., UC extending >=15 cm proximal to the rectum)
  • •8. Patients with history of extensive colitis or pancolitis of > 8 years duration or left-sided colitis of > 12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (if not, the patient should undergo a colonoscopy in lieu of a flexible proctosigmoidoscopy during screening).
  • •9. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one of the following agents below as defined in Section 4.2 of the protocol:
  • •- Oral 5-aminosalicylates (5-ASAs)
  • •- Corticosteroids
  • •- Immunosuppressives
  • •- TNF-alpha antagonists
  • •- Integrin antagonists
  • •10. May be receiving a therapeutic dose of the following drugs:
  • •a. Oral 5-ASA compounds provided that the dose has been stable for the 2 weeks immediately prior to randomization
  • •b. Oral corticosteroid therapy (prednisone at a stable dose <= 20 mg/day, budesonide at a stable dose <= 9 mg/day, or equivalent steroid) provided that the dose has been stable for the 4 weeks immediately prior to randomization if corticosteroids have just been initiated
  • •c. Azathioprine or 6-mercaptopurine provided that the dose has been stable for the 8 weeks immediately prior to screening. (These immunosuppressive agents must be discontinued at the time of randomization.)
  • •d. Probiotics (e.g., Culturelle, Saccharomyces boulardii) provided that the dose has been stab

排除标准

  • •1. Evidence of abdominal abscess or toxic megacolon at the initial screening visit
  • •2. Previous extensive colonic resection (subtotal or total colectomy)
  • •3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  • •4. Within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease:
  • •a. Non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide) other than those specifically listed in Section 6.12.1 of the protocol.
  • •b. A non-biologic investigational therapy
  • •c. An approved non-biologic therapy in an investigational protocol
  • •5. Within 60 days prior to randomization, receipt of any of the following:
  • •a. Infliximab, adalimumab, golimumab, certolizumab, vedolizumab
  • •b. Any other investigational or approved biologic agent
  • •6. Any prior exposure to natalizumab, efalizumab, or rituximab
  • •7. Previous treatment with more than 2 biologic agents
  • •8. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug
  • •9. Evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to randomization
  • •10. Currently require or are anticipated to require surgical intervention for UC during the study
  • •11. History or evidence of adenomatous colonic polyps that have not been removed
  • •12. History or evidence of colonic mucosal dysplasia
  • •13. Diagnosis of Crohn?s colitis or indeterminate colitis
  • •14. Infection with the Hepatitis B or C virus
  • •15. Active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
  • •a. History of tuberculosis (that has not been acceptably treated)
  • •b. A positive diagnostic tuberculosis (TB) test within one month of randomization defined as:
  • •i. a positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests OR
  • •ii. a tuberculin skin test reaction >=10 mm ( >=5 mm in patients receiving the equivalent of > 15 mg/day prednisone).
  • •c. Chest X-ray within 12 months of randomization in which active or latent pulmonary tuberculosis cannot be excluded
  • •16. Any known history of congenital or acquired immunodeficiency (e.g., common variable immunodeficiency, human immunodeficiency virus [HIV] infection [ELISA and Western blot] test result, organ transplantation)
  • •17. Clinically significant extra-intestinal infection (e.g., pneumonia, pyelonephritis) within 30 days prior to randomization
  • •18. Prior participation in any study of APD334
  • •19. History of any clinically significant medical condition that, in the investigator's opinion, would preclude participation in the study
  • •20. Recent history (within 6 months of screening visit) of cardio or cerebrovascular disease, ACS, MI, unstable angina, CVA, TIA at screening
  • •21. Any surgical procedure requiring general anesthesia within 30 days prior to randomization or plans to undergo major surgery during the study period
  • •22. History of retinal macular edema
  • •23. History of or signs and symptoms of progressive multifocal leukoencephalopathy (PML) as assessed by the PML Checklist
  • •24. History of cardiac arrhythmia, conduction system disease (including AV node dysfunction, 2nd or 3rd degree heart block, and sick sinus syndrome), or use of Class 1a and Class III anti-arrhythmic agents, or baseline QTc >=500 msec.
  • •25. FEV1 or FVC < 80% of predicted values (i.e., abnormal)
  • •26. Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunist

研究者

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