PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS. - ETRO UC5 (GA28950)

Hoffmann-La Roche0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月23日

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•* Treatment within 5 years prior to screening with one or two induction regimens that contain TNF inhibitors (including TNF inhibitor biosimilars)
•* 18-80 years of age inclusive, and able and willing to provide written informed consent.
•* Diagnosis of UC established at least 3 months prior to Day 1.
•* Moderately to severely active ulcerative colitis (UC) as determined by the Mayo Clinic Score assessment (MCS).
•* Washout of TNF inhibitor therapy for at least 8 weeks preceding Day 1
•* Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budenoside therapy, probiotics, AZA, 6-MP, or MTX if doses have been stable during the screening period.
•* Use of highly effective contraception as defined by the protocol.
•* Have received a colonoscopy within the past year or be wiling to undergo a colonoscopy in lieu of a flexible sigmoidoscopy at screening.

•* A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps.
•* Prior or planned surgery for UC.
•* Past or present ileostomy or colostomy.
•* Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, and efalizumab) as stated in the protocol.
•* Any prior treatment with anti-adhesion molecules (e.g., anti-MAdCAM-1)
•* Any treatment with tofacitinib during screening
•* Congenital or acquired immuno deficiency, chronic hepatitis B or C infection, Human Immonudeficiency Virus (HIV) positive, or history of tuberculosis (active or latent).
•* Evidence of or treatment for Clostridium difficile within 60 days prior to Day 1 or other intestinal pathogens within 30 days prior to Day 1
•* History of recurrent opportunisctic infections, severe disseminated viral infections and organ transplant
•* Any major episode of infection requiring treatment with intravenous (IV) antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to screening.
•* Received a live attenuated vaccine within 4 weeks prior to Day 1

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