GA46438 Phase 1 study of Afimkibart in Patients with Ulcerative Colitis
Research type
Research Study
Full title
A Phase I, Multicenter, Open-Label, Single-Agent Study to Assess the Pharmacokinetics of Cytochrome P450 Substrates after Treatment with Afimkibart in Participants with Moderately to Severely Active Ulcerative Colitis
IRAS ID
1013482
Contact name
N/A N/A
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Research summary
Ulcerative colitis (UC) is a chronic condition that causes inflammation and sores in the lining of the large intestine (colon) and rectum. This inflammation can lead to symptoms like abdominal pain, diarrhoea, and rectal bleeding. UC is a type of inflammatory bowel disease (IBD) and can significantly impact a person's quality of life. The exact cause of UC is unknown, but it involves an abnormal immune response in the gut. Treatment typically includes medication to reduce inflammation and manage symptoms, and in severe cases, surgery may be necessary.
This study is testing a medicine called afimkibart. This study aims to understand how afimkibart affects the way certain drugs are processed in the bodies of people with UC. It will look at whether afimkibart changes the way these drugs work and if there are any side effects when afimkibart is used for 10 weeks.
People (males and females) of 18 to 60 years of age with moderately to severely active ulcerative colitis can take part in the study if they meet the inclusion criteria.
Approximately 25 participants will take part globally with around 6 across 3 UK sites
The study will last around 31 weeks for each participant if they do not opt for the Long Term Extension phase. If they do choose to take part in the extension this will last around 5 years.
The study is sponsored by F. Hoffmann- La Roche
Research Summary; Version 1 dated 13 Jan 2026REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
26/EE/0043
Date of REC Opinion
2 Apr 2026
REC opinion
Further Information Favourable Opinion