IRB Study Number 25-007
Status Recruiting
Locations Cleveland Clinic Weston Hospital , Cleveland Clinic Main Campus
Institute Digestive Disease & Surgery Institute
Description
This study is for adults with moderately to severely active ulcerative colitis whose disease has not responded well enough to standard medications. It is testing an investigational medication (afimkibart) given first by IV and then by injections under the skin, compared with placebo, to see if it improves symptoms, heals the bowel, and is safe. Participants will be followed for about a year, with the option for longer treatment if they benefit and meet criteria.
Inclusion Criteria
Age 18–80 years
Weight 40 kg (88 lbs) or more
Doctor-confirmed diagnosis of ulcerative colitis for at least several months
Moderately to severely active UC at screening (ongoing symptoms and active disease on scope)
UC involving at least 15 cm of the colon
Has tried standard UC treatments (such as mesalamine, steroids, immunomodulators, or biologic/advanced therapies) and had inadequate response, loss of response, or intolerance
Able and willing to have colonoscopy/flexible sigmoidoscopy and all required study visits and tests
If of childbearing potential, willing to use reliable birth control during the study and for the required time after
Exclusion Criteria
Diagnosis of Crohn’s disease, indeterminate colitis, microscopic colitis, ischemic colitis, or other types of inflammatory bowel disease
History of colon removal, ileostomy/colostomy, or ileal pouch (J-pouch)
Known or suspected toxic megacolon, bowel perforation, severe strictures, or need for urgent bowel surgery
History of colorectal cancer or high-grade dysplasia in the colon, or other serious GI cancers
Significant uncontrolled medical conditions (e.g., severe heart, liver, or kidney disease)
Active serious infection, including tuberculosis, sepsis, CMV colitis, C. difficile, hepatitis B or C, or HIV
Recent use of certain prohibited medications that conflict with the study drug (per investigator review)
Prior treatment with afimkibart or known allergy to similar biologic drugs or study drug components
Pregnant, breastfeeding, or planning pregnancy during the study period
Any condition that, in the investigator’s opinion, would make participation unsafe or interfere with study assessments
