EUCTR2010-019558-42-SK进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- •2. Aged 18 to 65 years old, inclusive, at the time of informed consent.
- •3.Must have an established diagnosis of UC for at least 3 months and have at least 1 previous relapse.
- •4. Must have a flexible sigmoidoscopy (or colonoscopy if required) indicative of active UC as close to randomization as possible.
- •5. Must have >15 cm of active disease at Screening endoscopy.
- •6. Subjects diagnosed with UC for >10 years must have had a colonoscopy within 12 months of Week 0 to exclude dysplasia and neoplasia.
- •7. Must have active UC with a Total Mayo Score of 6 to 10 points and moderate to severe disease on endoscopy (Mayo endoscopic subscore of at least 2).
- •8. Subjects must complete a UC symptom collection diary as assessed during the Screening period.
- •9. Must have high sensitivity C-reactive protein (hsCRP) =2.87 mg/L.
- •10. All male subjects and female subjects of child bearing potential must be willing and able to continue contraception for 6 months after their last dose of study treatment.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with a diagnosis of indeterminate colitis or Crohn’s disease.
- •2. Subjects with an imminent need for surgery.
- •3. Subjects with toxic megacolon.
- •4. Subjects with primary sclerosing cholangitis.
- •5. Subjects with known colonic stricture.
- •6. Subjects with a history of colonic or small bowel obstruction or resection.
- •7. Stool culture positive with confirmatory re-test, for enteric infection, including parasitic infection, and C. difficile toxin
- •8. Subjects with a history of malignant disease, including solid tumors and hematologic malignancies
- •9. History of severe allergic or anaphylactic reactions
- •10. History of any clinically important cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease
- •11. Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring hospitalization or treatment with antibiotics within 4 weeks of Week 0.
- •12. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 6 months prior to Week 0.
- •13. Subjects with any laboratory test result at Screening considered clinically important (as determined by the Investigator) or:•alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.0 × upper limit of normal (ULN) •Hemoglobin =8.5 g/dL •Neutrophils <1.5 × 103/µL •Platelet count <150,000 cells/µL
- •14. Known history of, or positive test result for hepatitis B or C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb])
- •15. Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection
- •16. History of tuberculosis (TB) or positive PPD (positive Mantoux test defined as 10 mm of induration [size of raised lump, not redness]), or equivalent positive TB test result as per country clinical standards during the screening period.
- •17. Clinically important chest x-ray abnormality at Screening
- •18. If receiving corticosteroid treatment orally, subjects must have been on a stable dose (=20 mg prednisolone or equivalent per day) for at least 1 week prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 12.
- •19. If receiving 6-mercaptopurine or azathioprine (=2.5 mg/kg) treatment orally, subjects must have been on a stable dose for at least 8 weeks prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 24.
- •20. If receiving 5-aminosalicylic acid (5-ASA) treatment orally, subjects must be on a stable dose for at least 1 week prior to Mayo Score screening procedures, and must be willing to maintain the stable dose regimen through Week 12.
- •21. Treatment with another investigational product or approved therapy for investigational use within 8 weeks prior to Week 0.
- •22. Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins within 12 weeks prior to Week 0.
- •23. Treatment with an anti-TNF agent (including anti-TNF agents as part of an investigational study)
- •24. Treatment with methotrexate, cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil within 4 weeks prior to Week 0.
- •25. Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs)
研究者
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