IM011-127 A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis - IM011-127

Bristol-Myers Squibb0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 10

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 99（—）

入选标准

•1.) Type of Participant and Target Disease Characteristics
•a. A diagnosis of Ulcerative Colitis (UC) at least (>=) 3 months* duration prior
•to screening and source documents must include (i) an endoscopy report, which
•shows features consistent with UC, and (ii) a histopathology report showing
•features consistent with UC.
•If an endoscopy report is not available prior to screening, the screening
•endoscopy can be used to confirm the diagnosis. If a histopathology report is
•not available prior to screening, endoscopic biopsies can be obtained at the
•screening endoscopy (with appropriate consent) and sent to a local
•histopathology laboratory for reporting, to meet the criteria described above
•prior to randomization.
•b. UC disease distribution extending proximal to the rectum (ie, left-sided
•colitis or pancolitis)
•c. Moderately to severely active UC, defined by a modified Mayo score of 5 to 9
•points inclusive, which includes all of the following:
•i. A stool frequency (SF) subscore of >= 2, and
•ii. A rectal bleeding (RB) subscore >= 1, and
•iii. An endoscopic (ES) subscore of >= 2
•d. Must be up to date with surveillance for dysplasia and screening for
•colorectal neoplasia, according to local standard of care
•2.) Age and Reproductive Status
•a. Males and Females, ages 18 (or local age of majority) to 65 years,
•inclusive, at the time of screening.
•b. Women who are not of child-bearing potential are exempt from contraception
•requirements. Female subjects must have documented proof that they are not of
•childbearing potential
•c. Women of Child Bearing Potential (WOCBP) must have a negative highly
•sensitive serum or urine pregnancy test.
•(minimum sensitivity 25 IU/L or equivalent units of human chorionic
•gonadotropin) within 24 hours prior to the start of study treatment. If a urine
•test cannot be confirmed as negative (eg, an ambiguous result), a serum
•pregnancy test is required. The participant must be excluded from participation
•if the serum pregnancy result is positive.
•d. A female subject is eligible to participate if she is not pregnant or
•breastfeeding and at least one of the following conditions applies:
•(1) Is not a WOCBP
•(2) a WOCBP and using a contraceptive method(s) as described in the protocol
•during the intervention period (at a minimum until after the last dose of study
•intervention)
•e. Males who are sexually active with WOCBP must agree to follow instructions
•for contraception as desribed in the protocol
•f. Azoospermic males are exempt from contraceptive requirements
•3. ) Prior UC Medication Failure Inclusion Criteria
•a. Documentation of an inadequate response, loss of response, or intolerance to
•a treatment course of 1 or more of the following standard of care medications:
•i. Oral 5-aminosalicylic acids (5-ASAs) (eg, mesalamine, sulfasalazine,
•olsalazine, or balsalazide)
•ii. Corticosteroids (eg, prednisone or budesonide MMX)
•iii. Immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], or
•methotrexate [MTX]
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排除标准

•1.) Medical Conditions
•a. Women who are pregnant or breastfeeding
•2.) Ulcerative Colitis (UC) Exclusion Criteria
•a. UC involving the rectum only (UC proctitis).
•b. Current diagnosis of Crohn*s disease, indeterminate colitis, ischemic
•colitis or microscopic.
•c. Current or recent (within 12 weeks prior to randomization) evidence of
•fulminant UC (also known as acute severe UC) or toxic megacolon.
•d. Current or recent (within 12 weeks prior to randomization) evidence of
•bowel perforation or intra-abdominal abscess.
•e. Current or recent colonic diverticulitis. Subject must be adequately
•treated and off antibiotics for diverticulitis for 60 days prior to
•randomization.
•f. Current colonic adenomas or mucosal dysplasia
•i. A subject with adenomatous polyps may be eligible if the polyps have been
•completely removed or eradicated (documented). The subject must be free of
•polyps at randomization.
•ii. A subject with mucosal dysplasia may be eligible if the dysplasia has been
•completely removed/resected/eradicated (as applicable, documented), and the
•subject is free of dysplasia at randomization. This should be discussed with
•the BMS Medical Monitor/designee prior to screening
•iii. Subjects with a history of UC greater than (>) 8 years* duration (who have
•not had a colonoscopy in the prior 12 months) must have a full colonoscopy at
•Subjects who require a colonoscopy to screen for dysplasia (based on local
•guidelines) must have a full colonoscopy at screening
•Subjects who require a colonoscopy to screen for colorectal cancer (based on
•local guidelines) must have a full colonoscopy at screening.
•3.) Gastrointestinal (GI) Surgery Exclusion Criteria
•a. History or evidence of extensive colonic resection, subtotal or total
•colectomy, with or without a stoma or pouch.
•b. Current need for, or anticipated need for, surgical intervention for UC
•during the study.
•c. GI surgery within 3 months prior to randomization Subject must have adequate
•wound healing prior to randomization.
•4.) Additional Gastrointestinal (GI) Exclusion Criteria
•a. Current or recent (within 12 weeks prior to randomization) GI disease that
•may confound efficacy assessment or any GI disease associated with poor
•absorption of the investigational product (for example, untreated celiac sprue,
•bile salt-mediated diarrhoea, or short bowel syndrome).
•b. Receiving enteral feeding, defined formula diets, or total parenteral
•alimentation.
•5.) Immune and Infectious Disease Exclusion Criteria
•a. History of congenital or acquired immunodeficiency
•b. Known serious infection, defined as any infection requiring hospitalization
•or treatment with parenteral (intramuscular [IM] or IV) antimicrobial agents
•(eg, antibiotics, antiviral, antifungal, or antiparasitic agents) within 30
•days of the first dose of study treatment. Completion of oral antimicrobial
•agents within 2 weeks of the first dose of study treatment.
•Antibiotics used to cover a procedure such as endoscopy would not exclude the
•c. Current or recent (within 12 weeks prior to randomization) herpes zoster,
另有 2 项未显示

研究者

发起方

Bristol-Myers Squibb

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