EUCTR2017-003703-22-PL进行中（未招募）1 期
A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Immunic AG
- 入组人数
- 240
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
- •Induction phase 1)Male and female patients, aged 18 - 80 years
- •2)UC diagnosed more than 3 months before Screening (Day-30) as documented in the medical chart 3)Previous treatment failure defined as a)Patient had an inadequate response with,lost response to or was intolerant to approved or experimental immunomodulators or biologics(no more than 2 treatment failures with biologic drugs i.e.anti-tumor necrosis factor a antibodies or b)Patient had an inadequate response to, was intolerant to, or is corticosteroid dependent(corticosteroid-dependent patients are defined as i)unable to reduce steroids below the equivalent of prednisolone 10 mg/day within 3 months of starting steroids, without recurrent active disease or ii) who have a relapse within 3 months of stopping steroids)
- •4)Active disease defined as a)Mayo stool frequency score of =2 at Screening Visit 1 b)Mayo rectal bleeding score of =1 at Screening Visit 1 c)modified Mayo endoscopy subscore of =2 at the screening flexible sigmoidoscopy (endoscopy assessed by an independent central reader blinded to screening center and patient information) 5)Endoscopic appearance typical for UC and extending >15 cm from the anal verge as confirmed by an independent central reader (blinded to screening center and patient information) 6) Laboratory values: Neutrophil count >1500 cells/µL (>1.5x10^9/L), platelet count =100 000/mm3 (=100 10^9/L), serum creatinine <1.5 x upper limit of normal (ULN), total bilirubin, alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) <1.5 x ULN 7) Female patients must a)Be of non-child-bearing potential i.e.surgically sterilized(hysterectomy,bilateral salpingectomy,bilateral oophorectomy at least 6 weeks before Screening)or post-menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause) or b) If of child-bearing potential,must have a negative pregnancy test at Screening (blood test) and before the first study drug administration (Day 0 urine test).They must agree not to attempt to become pregnant,must not donate ova,and must use a highly effective contraceptive method 2 months before Screening, during treatment with IMU-838 and at least 3 months after the last dose of study therapy Highly effective forms of birth control are those with a failure rate less than 1% per year and include: -oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation-oral, injectable or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation-intrauterine device or intrauterine hormone-releasing system-bilateral tubal occlusion-vasectomized partner -sexual abstinence (acceptable only if it is the patient’s usual form of birth control/lifestyle choice) 8) Male patients must agree not to father a child or to donate sperm starting at Screening and throughout the clinical trial and for 3 months after the last dose of study medication. Male patients must also either -abstain from sexual intercourse with a female partner (acceptable only if it is the patient’s usual form of birth control/lifestyle choice), Or -use adequate barrier contraception during treatment with IMU-838 and for at least 3 months after the last dose of study medication And o)if they have a female partner of childbearing potential,the partner should use a highly effective contraceptive method as outlined in inclusion criterion 7And if they have
排除标准
- •Gastrointestinal exclusion criteria:
- •1.Diagnosis of Crohn’s disease, inflammatory bowel disease type unclassified, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
- •2.Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •3.History of colectomy with ileorectal anastomosis or ileal-pouch anal anastomosis or imminent need for colectomy (i.e.colectomy is being planned)
- •4.Active therapeutically uncontrollable abscess or toxic megacolon
- •5.Malabsorption or short bowel syndrome
- •6.History of colorectal cancer or colorectal dysplasia(with the exception of dysplasia in polyps which have been removed)
- •Infectious disease exclusion criteria
- •7.Clostridium difficile(C. difficile)infection
- •oEvidence of, or treatment for C. difficile infection within 30 days before first randomization
- •oPositive C. difficile toxin B stool assay during the screening period
- •8.Treatment for intestinal pathogens other than C. difficile within 30 days prior to first randomization
- •9.Other chronic systemic infections
- •oHistory of chronic systemic infections including but not limited to tuberculosis, human immunodeficiency virus (HIV), hepatitis B or C, within 6 months before Screening
- •oPositive interferon-gamma release assay (IGRAs) for Mycobacterium tuberculosis at Screening
- •oPositive HBsAg(hepatitis B virus surface antigen),HBcAb(hepatitis B core antibody), positive hepatitis C virus and/or HIV-antigen-antibody (HIV-Ag/Ab) test at Screening*
- •10.Any live vaccinations within 30 days prior to study drug administration except for the influenza vaccine
- •Other medical history and concomitant disease exclusion criteria
- •11.Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis, including hereditary hyperoxaluria or hereditary hyperuricemia
- •12.Diagnosis or suspected liver function impairment which may cause, as assessed by the investigator, a potential for fluctuating liver function tests during this trial
- •13.Renal impairment i.e. estimated glomerular filtration rate =60 mL/min/1.73m²
- •14.Serum uric acid levels at Screening >1.2 x ULN (for women >6.8 mg/dL, for men >8.4 mg/dL)
- •15.History or clinical diagnosis of gout
- •16.Known or suspected Gilbert syndrome
- •17.Indirect (unconjucated) bilirubin =1.2 x ULN at Screening (i.e. = 1.1 mg/dL)
- •18.Concurrent malignancy or prior malignancy within the previous 10 years except for the following: adequately-treated non-melanoma skin cancer and adequately-treated cervical cancer
- •Therapy exclusion criteria:
- •19.Use of any investigational product within 8 weeks or 5 x the respective half-life before first randomization, whatever is longer
- •20.Use of the following medications within 2 weeks before first randomization:
- •a.Tofacitinib
- •b.Methotrexate,
- •c.Mycophenolate mofetil
- •d.Any calcineurin inhibitors (e.g. tacrolimus, cyclosporine, or pimecrolimus)
- •e.Oral systemic corticosteroids >20 mg/day prednisolone equivalent including beclomethasone diproprionate (at >5 mg/day) and budesonide (multi-matrix [MMX] at >9 mg/day)
- •f.Oral aminosalicylates (e.g. mesalazines) >4 g/day
- •21.Use of the following medications within 4 weeks before first randomization:
- •a.Use of intravenous corticosteroids
- •b.Use of thiopurines including azathioprine, mercaptopurine and 6-thioguanine
- •c.Use of any rectal and topical aminosalicylates and/or budesonide
- •22.Use of oral systemic corticosteroids =20 mg/day prednisolone equivalent including beclomethasone diproprionate (at =5 mg
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