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临床试验/CTRI/2023/05/053176
CTRI/2023/05/053176招募中3 期

A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of ABX464 once daily for induction treatment in subjects with moderately to severely active ulcerative colitis - ABTECT-1

Abivax SA0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
招募中
发起方
Abivax SA
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

入排标准

入选标准

  • •A subject will be eligible to participate in this study if ALL the following criteria are met:
  • •1. Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects = 18 years old will be enrolled. To be eligible, adolescent subjects must weight = 40 kg and meet the definition of Tanner Stage 5 at the screening visit.
  • •2. Subjects must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures. For under-aged subjects, national requirements regarding consent should also be met.
  • •3. Documented diagnosis of UC confirmed by endoscopy and histology. Should histology results not be available at screening, results from biopsies taken at screening may be used.
  • •4. Active disease defined by modified Mayo score (MMS) = 5 with rectal bleeding subscore (RBS) = 1 and endoscopy subscore (MES) of 2 or 3 (confirmed by central reader).
  • •5. Subjects with documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids, immunosuppressant, biologic therapies, S1P receptor modulators and/or JAK inhibitors and/or new drugs approved during the study (note: failure to only 5-ASA is not accepted).
  • •a. Inadequate response to corticosteroids (CS) is defined as either a CS resistance (i.e., signs and symptoms of persistently active disease despite current or prior course of oral prednisone/prednisolone = 40 mg/d for at least 2 weeks, or to budesonide = 9 mg/d for at least 2 weeks, or to beclomethasone = 5 mg/d for at least 2 weeks) or a CS dependence (i.e., failure to taper to =10 mg of prednisone/prednisolone, < 9 mg/d of budesonide or < 5 mg of beclomethasone or relapse occurring within 3 months after stopping CS).
  • •Intolerance to CS includes (but not limited to) Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection.
  • •b. Inadequate response to immunosuppressants is defined as signs and symptoms of persistently active disease despite azathioprine treatment at 1.5 to 2.5 mg/kg/day for at least 8 weeks, or mercaptopurine 0.5 to 1.5 mg/kg/day for at least 8 weeks, or methotrexate 12.5 mg to 15 mg/week for at least 8 weeks
  • •Intolerance to immunosuppressant includes (but not limited to) nausea/vomiting, abdominal pain, pancreatitis, liver enzyme abnormalities, lymphopenia, infection.
  • •c. Inadequate response to biologics is defined as:
  • •Primary non responders to full induction course as in the USPI/SmPC of the following:
  • •- infliximab or biosimilars (= 5 mg/kg intravenously at 0, 2, and 6 weeks),
  • •- adalimumab or biosimilars (160 mg subcutaneous dose followed by 80 mg SC [or 80 mg SC dose in countries where this dosing regimen is allowed] followed by 40 mg SC dose at least 2 weeks apart),
  • •- golimumab (200 mg SC dose followed by 100 mg SC dose at least 2 weeks apart),
  • •- vedolizumab (300 mg IV at 0, 2, and 6 weeks),
  • •- ustekinumab (one single IV using weight-based dosing - 260 mg for subjects with body = 55 kg; 390 mg for subjects with body weight > 55 kg and = 85 kg; 520 mg for subjects with body weight > 85 kg),
  • •Loss of response is defined as recurrence of symptoms during maintenance course following primary response after full induction course (discontin

排除标准

  • •Subjects who meet ANY of the following exclusion criteria will be excluded from the study:
  • •1. Subjects with ulcerative colitis limited to an isolated proctitis (= 15cm from anal verge).
  • •2. Subjects with primary sclerosing cholangitis or autoimmune hepatitis.
  • •3. Subjects who have failed on 5-ASA therapy only.
  • •4. Subjects with CD or presence or history of fistula, indeterminate colitis, infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis).
  • •5. History or current evidence of toxic megacolon, fulminant colitis, bowel perforation.
  • •6. History of colon cancer, past or current evidence of low grade or high-grade colonic dysplasia and/or adenomatous polyps that have not been completely removed.
  • •7. Recent or planned bowel surgery or history of proctocolectomy or partial colectomy or current stoma.
  • •8. Subjects on antidiarrheals including those working on motility (e.g., loperamide, diphenoxylate with atropine, etc.).
  • •9. Subjects on probiotics (e.g., Culturelle® [Lactobacillus GG, i-Health, Inc.], Saccharomyces boulardii).
  • •10. Subjects who do not meet the washout period requirements prior to the screening endoscopy as described in the prohibited medication section (section 4.3.2) of the study protocol.
  • •11. Subjects with the following hematological and biochemical laboratory parameters obtained during the screening period:
  • •Hemoglobin = 8.0 g dL-1
  • •Absolute neutrophil count < 750 mm-3
  • •Platelets < 100,000 mm-3
  • •Creatinine clearance < 60 mL.min-1 (Cockroft-Gault formula)
  • •Total serum bilirubin > 1.5 x ULN
  • •Alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 x ULN
  • •12. Subjects with the following conditions (infection):
  • •Subjects with chronic or recurrent grade 3 or grade 4 infection within the last 2 months prior to screening or a history of opportunistic infection while not on immunosuppressive therapy.
  • •Herpes zoster reactivation within the last 2 months prior to screening.
  • •Subjects with active infection at screening or any major episode of infection that required hospitalization or treatment with intravenous antibiotics within 1 month of screening or during screening. Fungal infection of nail beds is allowed.
  • •Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridium difficile toxin at screening. If C. difficile is positive, subject may be treated and retested = 2 weeks after completing treatment.
  • •Subjects with HIV infection.
  • •Subjects having acute or chronic hepatitis B infection at screening (positive for hepatitis B surface antigen [HbsAg], or negative for HbsAg and positive for anti-hepatitis B core antibody in conjunction with detectable HBV DNA, or detectable HBV DNA).
  • •Subjects having acute or chronic hepatitis C infection at screening as defined by positive for hepatitis C antibody (subjects successfully treated and without recurrence = 1 year with no detectable HCV RNA [assessed centrally] are eligible).
  • •Active tuberculosis (TB) or untreated latent TB are ruled out. For subjects with positive or intermediate QuantiFERON test see section 5.3.8.1 of the current study protocol.
  • •13. Subjects with an uncontrolled ischemic heart disease and/or a history of congestive heart failure with New York Heart A

研究者

发起方
Abivax SA

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