EUCTR2015-001942-28-PL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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 156
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 # 24)
- •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 10 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
- •TNFa 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 screening - endoscopy assessment 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) pr
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 3 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. Current evidence of adenomatous colonic polyps that have not been removed
- •12. Current 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:
- •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 opportunistic infection within 4 weeks of screening
- •27. History of more than one episode of herpes zoster or any episode of disseminated zoster
- •28. Without documented positive varice
研究者
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