An Adaptive Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY3471851 (NKTR-358) in Patients with Moderately to Severely Active Ulcerative Colitis - INSTRUCT-UC

Eli Lilly and Company0 个研究点目标入组 200 人开始时间: 2020年12月29日最近更新: 2022年5月16日

研究概览

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•Are male or female patients =18 and =80 years of age at the time of initial screening
•Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) =2, with endoscopy performed within 14 days before baseline
•Have an established diagnosis of UC of =3 months in duration before baseline (Week 0)
•Have evidence of UC extending proximal to the rectum (with =15 centimeter (cm) of involved colon)
•Have up-to-date colorectal cancer surveillance performed according to local standard
•Participants are either one of the following:
•-Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence and neither failed or demonstrated intolerance to advanced OR,
•-Have failed or demonstrated intolerance to advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor [TNF} antagonists, anti-integrin therapies, anti- IL12/23p40 therapies, Janus kinase [JAK] inhibitor)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 190
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the rectum only; less than 15 centimeter (cm) from the anal verge or Crohn’s disease
•Have had or will need abdominal surgery for UC (for example, subtotal colectomy)
•Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg, tumor necrosis factor [TNF] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase [JAK] inhibitor)
•Have evidence of active tuberculosis (TB), or have a past history of active TB, regardless of treatment, or are diagnosed with latent tuberculosis infection (LTBI) at screening
•Have human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), or acute or chronic hepatitis B infection or current hepatitis C infection
•Have had recent clostridium difficile , cytomegalovirus or other intestinal infection
•Have had lymphoma, leukemia, or any malignancy within the past 10 years
•Are pregnant, breastfeeding, or planning pregnancy (women only), or within 20 weeks after receiving the last dose of study agent

发起方