An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis
- Conditions
- lcerative colitisMedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-003123-57-PL
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
(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
OR
- 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)
OR
(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 documented history of failure to re
(12) have been diagnosed with indeterminate colitis, proctitis or CD
(13) have had surgery for treatment of UC
(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 beforescreening endoscopy
(15) have previous exposure to any biologic therapy targeting IL-23 licensed or investigational
(16) have been treated with any investigational drug for UC within 30 days before the initial screening visit
(17) have evidence of abdominal abscess or toxic megacolon during screening
(18) have colonic resection, subtotal or total colectomy
(19) have evidence of active or latent TB
(20) have had any malignancy within 5 years of screening
(21) are investigator site personnel directly affiliated with this study or their families
(22) are Lilly employees or employees of third -party organizations (TPOs) involved with the study
(23) are currently enrolled in a clinical trial not compatible with this study
(24) have previously completed or withdrawn from this study or any other study investigating LY3074828
(25) have received live, attenuated vaccine(s) within 2 months of screening or intend to receive such during the study
(26) test positive for human immunodeficiency virus antibodies at screening
(27) test positive for hepatitis B virus at screening
(28) test positive for hepatitis C virus at screening
(29) had Clostridium difficile infection within 30 days of screening endoscopy or test positive at screening, or other intestinal pathogen with 30 days before screening endoscopy. Subject must not have signs of an ongoing infection related to an intestinal pathogen
(30) have any clinically significant extra-intestinal infection or opportunistic, chronic, or recurring infection within 6 months before screening
(31) are unsuitable for inclusion in the study in the opinion of the investigator or sponsor for any reason that may compromise the subject’s safety or confound data interpretation
(32) Exclusion Criterion (32) applies to study sites in Japan only. For study sites in Japan, see the Japan protocol addendum
(33) are pregnant, lactating, or planning pregnancy (either men or women) while enrolled in the study or within 4 months after receiving the last dose of study agent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method