CTRI/2025/02/080762尚未招募3 期
A Parallel-Group Treatment, Double-Blind, 2-Arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects Aged 18 to 80 Years Inclusive With Moderate to Severe Active Ulcerative Colitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 748
- 试验地点
- 25
- 主要终点
- To demonstrate equivalent efficacy of AVT16 to Entyvio.
研究概览
简要总结
The study is a parallel-group, active comparator, multicenter study in subjects with moderate to severe active UC. It is a double-blind study wherein subjects and investigators will be blinded to the Investigational Product.
The study consists of a screening period (4 weeks), an active period (46 Weeks), and an end-of-study (EoS) visit (Week 52). The study duration will be up to 56 weeks including a 4-week screening period. The EoS visit will be at Week 52.
The Data Safety Monitoring Board (DSMB) will be an independent committee that will review and analyze on a regular basis, safety and efficacy data throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects aged 18 to 80 years inclusive at the time of signing the informed consent form (ICF) who are voluntarily able to give informed consent.
- •Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least ONE of the following conditions applies: a. Is not a woman of childbearing potential (WOCBP), defined as:.
- •Surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the subject’s medical records, medical examination, or medical history interview), or.
- •Postmenopausal (defined as no menses for 12 months without an alternative medical cause). A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient). Female subjects on HRT and whose menopausal status is in doubt will be required to use 1 of the nonestrogen hormonal highly effective contraception methods from screening (signing the ICF) until at least 15 weeks after IP administration if they want to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment. b. Is a WOCBP who agrees to use a highly effective method of contraception consistently and correctly from screening (signing the ICF) until at least 15 weeks after the last IP administration.
- •Nonsterilized male subjects with female partners of childbearing potential are eligible to participate if they agree to 1 of the following from screening (signing the ICF) until at least 15 weeks after IP administration: a. Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. b. Agree to use a male condom and have their partner use a contraceptive method with a failure rate of less than 1% per year when having penile vaginal intercourse with a WOCBP who is not currently pregnant. c. Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration. d. In addition, male subjects must refrain from donating sperm from screening (signing the ICF) until at least 15 weeks after IP administration.
- •Diagnosis of UC established at least 3 months prior to baseline endoscopy by clinical and endoscopic evidence and corroborated by a histopathology report at Baseline.
- •Moderately to severely active UC as determined by a complete Mayo Score of 6 to 12 with an endoscopic subscore greater than or equal to 2 within 14 days prior to the first dose of IP.
- •Evidence of UC extending proximal to the rectum (greater than or equal to 15 cm from the anal verge) confirmed by endoscopy at least 3 months prior to baseline endoscopy.
- •Subjects with extensive colitis or pancolitis of more than or equal to 8 years duration or left sided colitis of more than or equal to 12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit (may be performed during screening).
- •Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age more than or equal to 50 years, or another known risk factor must be up to date on colorectal cancer surveillance (may be performed during screening).
- •Demonstrated, over the previous 5-year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below: a. 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 IV for 1 week OR.
- •Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally OR.
- •History of intolerance of corticosteroids (including, but not limited to Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection). b. Immunomodulators.
- •Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine (greater than or equal to 1.5 mg/kg) or 6 mercaptopurine (greater than or equal to 0.75 mg/kg) OR.
- •History of intolerance of at least one immunomodulator (including, but not limited to, nausea/vomiting, abdominal pain, pancreatitis, liver function tests [LFT] abnormalities, lymphopenia, thiopurine methyltransferase [TPMT] genetic mutation, infection).
- •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 immediately prior to baseline endoscopy. b. Oral corticosteroid therapy (prednisone at a stable dose less than or equal to 20 mg/day, or equivalent steroid) provided that the dose has been stable for 2 weeks prior to baseline endoscopy and must be stable for atleast two weeks after dosing. c. Probiotics (eg, Culturelle, Saccharomyces boulardii) provided that the dose has been stable for the 2 weeks immediately prior to baseline endoscopy. d. Antidiarrheals at a stable dose (eg, 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 baseline endoscopy. Initiation or increase in dose leads to subject discontinuation.
排除标准
- •The exclusion criteria are divided into 3 categories as follows: • gastrointestinal exclusion criteria, • infectious disease exclusion criteria, and • general exclusion criteria. Subjects will be excluded from the study if any of the following criteria apply at any time starting from screening up to Day 0 prior to IP administration: Gastrointestinal Exclusion Criteria
- •Evidence of abdominal abscess or toxic megacolon or fulminant stage of disease during the screening period.
- •Extensive colonic resection, subtotal, or total colectomy.
- •Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- •Prior treatment with TNF antagonist and/or any other biological therapy for UC.
- •Have received any of the following for the treatment of underlying disease: a. Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those permitted in the study if last dose was given 8 weeks prior to the baseline endoscopy. b. A nonbiologic investigational therapy.
- •Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline endoscopy.
- •Evidence of or treatment for Clostridium difficile infection within 60 days or other intestinal pathogen (eg, Salmonella, Escherichia coli, etc.) within 30 days prior to baseline endoscopy.
- •Currently require or are anticipated to require surgical intervention for UC during the study.
- •History or evidence of adenomatous colonic polyps that have not been removed.
- •History or evidence of any grade of colonic mucosal dysplasia.
- •Diagnosis of Crohn’s colitis or indeterminate colitis. Infectious Disease Exclusion Criteria
- •Chronic hepatitis B or C infection.
- •Active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following: a. History of TB. b. A positive diagnostic TB test within 1 month of enrollment defined as:.
- •a positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests. c. Chest X-ray within 3 months of enrollment in which active or latent pulmonary TB cannot be excluded. Note: Subjects with an indeterminate QuantiFERON test are allowed if they have all of the following: d. No evidence of active TB on chest radiograph within 3 months prior to the first dose of IP. e. Documented history of at least 3 weeks of prophylaxis initiation prior to receiving IP in accordance with local recommendations and intend to complete its entire course during the study. f. No known exposure to active TB after most recent prophylaxis. g. Asymptomatic at Screening and Baseline. Investigators should check with the medical monitor before enrolling such subjects.
- •Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, HIV infection, organ transplantation).
- •Any live vaccinations within 30 days prior to IP administration except for an influenza vaccine.
- •Clinically significant extra-intestinal infection (eg, pneumonia, pyelonephritis) within 30 days prior to baseline endoscopy. General Exclusion Criteria
- •Previous exposure to vedolizumab.
- •Female subjects 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 IP administration.
- •Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise subject safety.
- •Have had any surgical procedure requiring general anesthesia within 30 days prior to baseline endoscopy or are planning to undergo major surgery during the study period.
- •Any history of malignancy, except for the following: (a) adequately treated nonmetastatic basal cell skin cancer; (b) any other type of nonmelanoma skin cancer that has been adequately treated and has not recurred for at least 5 years prior to baseline endoscopy; and (c) adequately treated in situ cervical cancer that has not recurred for at least 5 years prior to baseline endoscopy.
- •History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
- •Positive PML subjective symptom checklist prior to the administration of the first dose of IP.
- •Any clinically relevant laboratory abnormalities for hematology and for biochemistry tests of blood and urine during screening as judged by the principal investigator (PI).
- •Current or recent history (within 1 year prior to baseline endoscopy) of alcohol dependence or illicit drug use.
- •Active psychiatric problems that, in the investigator’s opinion, may interfere with compliance with the study procedures.
- •Any person for whom the following are true: 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.
结局指标
主要结局
To demonstrate equivalent efficacy of AVT16 to Entyvio.
时间窗: From baseline to Week 52
次要结局
- To further compare the efficacy of AVT16 with Entyvio.(From baseline to Week 52)
- To compare the safety of AVT16 with Entyvio.(From baseline to Week 52)
- To compare the immunogenicity of AVT16 with Entyvio.(From baseline to Week 52)
- To compare the PK of AVT16 with Entyvio.(From baseline to Week 52)
研究者
Rashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
研究点 (25)
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