A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)

Launched by PROMETHEUS BIOSCIENCES, INC., A SUBSIDIARY OF MERCK & CO., INC. (RAHWAY, NEW JERSEY USA) · Aug 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tulisokibart to see how safe and effective it is for people with moderately to severely active ulcerative colitis (UC), a condition that causes inflammation and ulcers in the digestive tract. The trial lasts for 12 weeks, and after that, participants have the option to continue for an additional 170 weeks. The study is currently active but not recruiting new participants.

To be eligible for this trial, individuals must have a confirmed diagnosis of ulcerative colitis and must experience moderate to severe symptoms. They should also have tried other treatments, like steroids or immunosuppressants, without success. Unfortunately, people with certain other conditions, like Crohn's disease or severe complications from UC, cannot participate. If someone joins the trial, they will receive tulisokibart and will be closely monitored for any side effects and how well the medication works for their symptoms. This study aims to find a better treatment option for those struggling with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• • Confirmed diagnosis of ulcerative colitis (UC)
• • Has moderately to severely active UC as defined by 3-component Modified Mayo score
• • Must have corticosteroid dependence or have had no response, insufficient response, loss of response, and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (anti-TNF), anti-integrin, anti-interleukin 12/23 (anti-IL12/23), Janus kinase (JAK) inhibitor, Sphingosine 1-phosphate receptor (S1PR) modulator.
• Exclusion Criteria:
• The main exclusion criteria include but are not limited to the following:
• • Has diagnosis of Crohn's disease or indeterminate colitis
• • Has current evidence of fulminant colitis, toxic megacolon, bowel perforation, total proctocoloectomy or partial colectomy
• • Has current or impending need for colostomy or ileostomy
• • Has had surgical bowel resection within 3 months before screening
• • Has past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed