EUCTR2020-001398-59-LV进行中（未招募）1 期
Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Provision of signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment.
- •2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •3. Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose.
- •4. Male or female 18 to 75 years of age, inclusive.
- •5. Diagnosis of moderate to severe active UC made at least 3 months before the screening visit. The diagnosis of UC must have been confirmed by endoscopy, with a minimal extent of 15 cm from anal margin and histology (i.e., histopathology report available in the patient’s file); however, a biopsy for a local histopathology assessment at screening can substitute this requirement.
- •6. No previous biologic therapy (i.e., TNF antagonists, vedolizumab or ustekinumab) and prior or current UC documented medication history that includes at least 1 of the following:
- •a) Corticosteroids:
- •i) No or insufficient response after at least 8 weeks treatment course by oral corticosteroids with initial dose at least 40 mg of prednisolone equivalent, or 4 weeks of 9 mg budesonide continuously;
- •ii) OR Inability to reduce oral corticosteroid dose below 10 mg of prednisolone equivalent after 6 weeks of continuous treatment;
- •iii) OR Experiencing UC relapse within 12 weeks of successful completion of corticosteroid treatment course;
- •iv) OR Intolerance to corticosteroids.
- •b) Immunosuppressive agents:
- •i) No or insufficient response after at least 12 weeks treatment course in a dose at least 1.5 mg/kg azathioprine or 0.75 mg/kg 6-mercaptopurine (6-MP);
- •ii) OR Intolerance to azathioprine or 6-MP.
- •Previous or current biologic therapy with documented history of an inadequate clinical response to, loss of response to, or intolerance to at least 1 of the following agents used at a dose and regimens approved for the treatment of UC for sufficient time:
- •Anti-TNF-a agents
- •Vedolizumab
- •Ustekinumab
- •7. Patient currently receiving 1 or more of the following medication(s) for UC is eligible, provided that he/she has been receiving such treatment(s) for at least 4 weeks and with no change in dose or frequency in the 2 weeks prior to screening:
- •a. Oral aminosalicylates anticipating that the dose at screening has to be maintained until Week 10.
- •b. Prednisone (stable doses = 20 mg/day) or equivalent, budesonide MMX (stable doses = 9 mg/day), or beclomethasone dipropionate (stable doses = 5 mg/day), anticipating that these stable doses have to be maintained until Week 10.
- •8. Patients who have been previously receiving anti-TNF-a therapy or vedolizumab or ustekinumab must have discontinued therapy = 8 weeks before the screening visit.
- •9. For patients with UC >8 years, results of a surveillance colonoscopy conducted within 2 years prior to screening are required to rule out dysplasia. This full colonoscopy might be done at screening instead of the procto-sigmoidoscopy to fulfill this requirement.
- •10. Either chest x-ray within the 3 months prior to screening and/or a negative quantiFERON TB Gold In Tube test according to local guidelines and standard of care to exclude active or latent TB infection.
- •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
排除标准
- •1. Stoma, proctocolectomy, or subtotal colectomy
- •2. Physician judgment that patient is likely to require any surgery for UC during the study duration, or double-blind phase duration at least
- •3. Evidence of fulminant colitis, toxic megacolon, or perforation
- •4. Current or recent (within 4 weeks prior to screening) hospitalization for UC care and/or treatment with IV steroids
- •5. The following laboratory results at screening:
- •a. Elevation at screening of aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 3 × the upper limit of normal (ULN) or total bilirubin > 2 × ULN (unless due to Gilbert’s disease) or evidence of chronic liver disease
- •b. Platelet count < 100,000/mm3
- •c. Hemoglobin (Hgb) < 8.5 g/dL
- •d. Neutrophils < 1500/mm3
- •e. Lymphocytes < 800/mm3
- •f. Absolute white blood cell (WBC) count < 3000/mm3
- •6. Crohn’s disease or indeterminate colitis or any other diagnosis not consisting with UC
- •7. History or evidence of incompletely resected colonic dysplasia or unconventional lesion at risk of colonic adenocarcinoma
- •8. Stool culture or other examination positive for enteric pathogen, including Clostridium difficile (C. diff) toxin. If positive, the patient should be treated and rescreening is allowed.
- •9. Men or women with childbearing potential not willing to use adequate birth control during the study. Adequate birth control includes surgical sterilization, intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, partner’s vasectomy, double-barrier method (condom, diaphragm with spermicide), or abstinence during study and 30 days following the last follow-up visit. Women of childbearing potential will enter the study after a negative pregnancy test.
- •10. Breastfeeding
- •11. Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) from screening through the end of the study
- •12. Use of topical steroids and/or topical 5-aminosalicylic acid preparations within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
- •13. Use of antidiarrheals within 2 weeks before the screening visit (all such medications should be withdrawn at least 2 weeks prior to the screening visit)
- •14. Treatment with azathioprine, 6-MP, methotrexate (MTX), cyclosporin, tacrolimus, sirolimus, leflunomide and/or mycophenolate mofetil within 4 weeks before the screening visit (all such medications should be withdrawn at least 4 weeks prior to the screening visit)
- •15. Previous treatment with more than 3 biologics including anti-TNF-a and/or anti-integrin and/or ustekinumab
- •16. Prior treatment with a JAK inhibitor
- •17. Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, pulmonary, endocrine, or other major systemic disease that would put the patient at risk by participating in the study in the opinion of the investigator
- •18. A recognized hereditary, congenital, or acquired immunodeficiency disease including human immunodeficiency virus (HIV) infection and other cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia
- •19. Known active viral, bacterial, fungal, mycobacterial infection, or other infection or any major infection that required hospitalization or treatment with IV antibiotics or antifungal within 30 days of screening or that required treatment with oral antibiotics within 14 days of screening
- •20. History or known presence of chronic or recurrent infection (hepatitis B, C, HIV)
研究者
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