EUCTR2015-003123-57-DK进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
入选标准
- •(1) have given written informed consent approved by the ERB (ethical review board) governing the site
- •(2) are male or female subjects =18 and =75 years of age at the time of initial screening
- •(2a) Male subjects agree to use a reliable method of birth control during the study and for 3 months, which is greater than 5 half-lives, after the last dose of investigational product.
- •(2b) female subjects:
- •- are women of childbearing potential whose serum pregnancy test results are negative and who agree to use a reliable method of birth control (eg, condom, sponge, or diaphragm combined with spermicidal foam, gel, or cream; ongoing hormonal contraception [oral, intramuscular, depot, or transdermal], such as Depo-Provera, Evra, or NuvaRing; an intrauterine device; or complete abstinence from sexual intercourse with men) during the study and for 3 months after the last dose of the investigational product
- •- are not women of childbearing potential, defined as having: bilateral oophorectomy, tubal ligation, or hysterectomy at least 6 weeks before screening; spontaneous amenorrhea for = 12 months, not induced by a medical condition or medications; or spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone level greater than 40 mIU/mL at screening
- •(3) venous access sufficient to allow blood sampling and IV administration (if applicable), as per the protocol
- •(4) have had a diagnosis of UC for =3 months before baseline (endoscopic evidence corroborated by a histopathology report); a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the baseline endoscopy procedure if a histopathology report is not available
- •(5) have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore =2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
- •(6) have evidence of UC extending proximal to the rectum (=15 cm of involved colon)
- •(7) have documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before baseline (may be performed during screening) for subjects with pancolitis of >8 years’ duration or left-sided colitis of >12 years’ duration
- •(7a) up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
- •(8) subjects must either:
- •(8a) be naive to biologic therapy (such as TNF antagonists, vedolizumab, or experimental UC biologics) and have at least 1 of the following:
- •- inadequate response or failure to tolerate current treatment with oral or IV corticosteroids or immunomodulators (6-MP or AZA) or
- •- history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC)
- •(8b) have received treatment with 1 or more biologic agents (such as TNF antagonists, vedolizumab, or experimental UC biologics) at doses approved for the treatment of UC with or without documented history of fa
排除标准
- •(12) have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or CD
- •(13) have had surgery for treatment of UC or are likely to require surgery for UC during the study
- •(14) have received any of the following for treatment of UC:
- •(14a) cyclosporine or thalidomide within 30 days of screening endoscopy
- •(14b) corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-ASA within 30 days of screening endoscopy
- •(14c) have used apheresis (eg, Adacolumn apheresis) =2 weeks before screening endoscopy
- •(15) have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational
- •(16) have been treated with any investigational drug for UC within 30 days or 5 half-lives of the drug (whichever is longer) before the initial screening visit (Visit 1), OR with interferon therapy within 8 weeks before baseline
- •(17) have evidence of abdominal abscess or toxic megacolon during screening
- •(18) have extensive colonic resection, subtotal or total colectomy, ileostomy, colostomy, or fixed symptomatic stenosis of the intestine
- •(19) have evidence of active or latent TB (refer to Section 10.3.2.2 of the protocol for details on full TB exclusion criteria)
- •(20) have had any malignancy within 5 years of screening, except for basal cell or squamous epithelial carcinoma of the skin that has been resected with no evidence of metastatic disease for at least 3 years OR cervical carcinoma in situ with no evidence of recurrence within 5 years of screening
- •(21) are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •(22) are Lilly employees or employees of third -party organizations (TPOs) involved with the study
- •(23) are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device, OR are concurrently enrolled in any other type of medical research not scientifically or medically compatible with this study, per investigator judgment
- •(24) have previously completed or withdrawn from this study or any other study investigating LY3074828. This criterion does not apply to subjects undergoing rescreening procedures.
- •(25) have received live, attenuated vaccine(s) within 2 months of screening or intend to receive such during the study; vaccines should be avoided for 2 months after the last dose of study drug. Uses of nonlive (inactivated) vaccinations are allowed for all subjects
- •(26) have HIV/AIDS or test positive for human immunodeficiency virus antibodies at screening
- •(27) have hepatitis B or test positive for hepatitis B virus (HBV) at screening, defined as: (1) positive for hepatitis B surface antigen or (2) positive for anti–hepatitis B core antibody (HBcAb+) and positive confirmatory polymerase chain reaction (PCR) for HBV, regardless of anti–hepatitis B surface antibody status
- •(28) have hepatitis C or test positive hepatitis C virus at screening, defined as: positive result for hepatitis C antibody and posi
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