A randomized, double-blind, multicenter phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE) - PB016-03-01

Polpharma Biologics S.A.0 个研究点目标入组 679 人开始时间: 2023年2月21日最近更新: 2024年7月22日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Polpharma Biologics S.A.
入组人数: 679

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

年龄范围: 18 至 65+（—）
性别: All

入选标准

•1.Age =18 and =80 years at Screening., 10.Demonstrated an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents: Corticosteroids Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone 30 mg daily orally for 2 weeks or intravenously for 1 week. OR Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally (i.e., corticosteroid dependent patients). OR History of intolerance to corticosteroids (including, but not limited to Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection). Immunomodulators Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (=1.5 mg/kg) or 6-mercaptopurine mg/kg (=0.75 mg/kg). OR History of intolerance to at least one immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, LFT abnormalities, lymphopenia, TPMT genetic mutation, infection). Tumor Necrosis Factor alpha (TNFa) antagonists Non-responders/inadequate response despite a history of at least one induction regimen/loading dose of TNFa antagonists as per summary of product characteristics (SmPC). OR Recurrence of symptoms during maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not qualify). OR History of intolerance to TNFa antagonists (including, but not limited to site/infusion-related reaction, demyelination, congestive heart failure, infection)., 11.May be receiving a therapeutic dose of the following drugs: a.Oral 5-aminosalicylic acid (5-ASA) compounds provided that the dose has been stable for the 2 weeks prior to randomization. b.Oral corticosteroid therapy (at a dose of =30 mg/day prednisone equivalent) provided that the dose has been stable for the 4 weeks immediately prior to randomization (if corticosteroids have just been initiated), or for the 2 weeks immediately prior to randomization (if corticosteroids are being tapered). c.Probiotics (e.g., Culturelle, Saccharomyces boulardii) provided that the dose has been stable for the 2 weeks immediately prior to randomization. d.Antidiarrheals (e.g., loperamide, diphenoxylate with atropine) for control of chronic diarrhea. e.Azathioprine or 6-mercaptopurine provided that the dose has been stable for the 8 weeks immediately prior to randomization., 12.Able to participate in all aspects of this clinical study., 13.Male or female patient who is voluntarily able to give informed consent., 2.At Screening, females of childbearing potential must be non pregnant and non-lactating; or females should be of non childbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1 year post-menopausal [amenorrhea duration of 12 consecutive months]); non-pregnancy will be confirmed for all females of childbearing potential by a serum pregnancy test conducted at Screening., 3.Female patients of childbearing potential, with a fertile male sexual partner, must use highly effective contraception from Screening until 18 weeks after the last dose of study drug., 4.Male patients who are sexually active with women of childbearing potential agree they will use highly effective contraception from Screening until 30 days after the last dose of study drug if not surgically sterilized at least 6 months b

排除标准

•1.Previous exposure to vedolizumab (Entyvio® or any other investigational vedolizumab containing product)., 18.Has any live vaccination within 30 days prior to Screening or is planning to receive any live vaccination during participation in the study., 19.Has used a topical (rectal) treatment with (5-ASA) or corticosteroid enemas/suppositories within 2 weeks prior to randomization unless taken on stable dose for at least 2 weeks before randomization., 2.Female patients who are lactating or have a positive serum pregnancy test during the Screening Period or a positive urine pregnancy test on Day 0 prior to study drug administration., 20.Has a history of hypersensitivity or allergies to the ingredients of Entyvio®., 21.History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease that, in the opinion of the Investigator, would confound the study results., 22.Positive PML subjective symptom checklist prior to the administration of the first dose of study drug., 23.Current or recent history (within one year prior to randomization) of alcohol dependence or illicit drug abuse., 24.Active psychiatric problems that, in the Investigator’s opinion, may interfere with compliance with the study procedures., 25.Any of the following laboratory abnormalities during the Screening Period: a.Hemoglobin level <8 g/dL. b.WBC count <3 × 109/L. c.Lymphocyte count <0.5 × 109/L. d.Platelet count <100 × 109/L or >1200 × 109/L. e.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN). f.Alkaline phosphatase >3 × ULN. g.Serum creatinine >2 × ULN., 26.Has received total parenteral nutrition or albumin in the last 30 days prior to randomization., 10.Diagnosis of Crohn’s disease, microscopic colitis, ischemic colitis or indeterminate colitis., 27.Has any unstable or uncontrolled cardiovascular disorder, heart failure moderate to severe (New York Heart Association Class III or IV), any pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the Investigator, would confound the study results or compromise patient safety., 28.Any persons who are: a.An employee of the study site, Investigator, contract research organization (CRO) or Sponsor. b.A first-degree relative of an employee of the study site, the Investigator, CRO, or Sponsor. c.Unable to attend all the study visits or comply with study procedures., 3.Within 30 days prior to randomization, has received any of the following for the treatment of underlying disease: a.Non-biologic therapies (e.g., cyclosporine, thalidomide) other than those specifically listed in Inclusion Criterion 11. b.A non-biologic investigational therapy. c.An approved non-biologic therapy in an investigational protocol., 4.Has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives, prior to randomization (the choice is based on the Investigator’s discretion)., 5.Has had prior exposure to approved or investigational anti integrin antibodies (e.g., natalizumab, efalizumab, etrolizumab, AMG-181, anti-MAdCAM-1 antibodies) or anti-CD20 antibodies (e.g., rituximab)., 6.Evidence of abdominal abscess or toxic megacolon at the Screening Visit., 7.Extensive colonic resection, subtotal or total colectomy., 8.History of ileostomy, colostomy, or known fixed symptom

研究者

发起方

Polpharma Biologics S.A.

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