TOPAZ-UC

Summary

Ulcerative colitis (UC) causes inflammation and sores (ulcers) in the lining of the lower large intestine (colon and rectum). UC usually starts between the ages of 15 and 30 years and often causes abdominal pain and blood or pus in diarrhea. Other symptoms of UC include rectal bleeding, loss of appetite, severe tiredness, and joint pain. In addition to surgical options, UC treatment usually involves medication to control inflammation. One medicine used currently to treat adults with moderately to severely active UC is mirikizumab. This drug blocks an immune-system protein (IL-23) that can become overactive and trigger excessive inflammation. About half of the people with UC have mild symptoms. However, some patients with UC need more inflammation control than what mirikizumab provides.

The TOPAZ-UC study asks whether giving the investigational drug LY4268989 with mirikizumab is effective in adults with moderately to severely active UC. Once a participant joins TOPAZ-UC, they're assigned randomly (50:50, like a coin toss) to receive either mirikizumab and LY4268989 or only mirikizumab. Neither the lead scientist nor the participants knows or can choose which treatment they get. Participation in TOPAZ-UC lasts approximately 118 weeks, including 104 weeks of treatment, and may include up to 21 clinic visits.

To be included in TOPAZ-UC, participants must be / have

• Adult (18-80 years old)

To be included in TOPAZ-UC, participants must not be / have

• Current diagnosis of Crohn disease, inflammatory bowel disease (IBD), or primary sclerosing cholangitis
• Had or need bowel resection or intestinal or intra-abdominal surgery
• Evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis

Keywords
KWAN; Mirikizumab; Ulcerative colitis