Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis

The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis/diarrhoea will reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis. The main question it aims to answer is: • Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis/diarrhoea compared to corticosteroids alone. Participants will be randomised 1:1: Arm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2. Study patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.

NCT Number	NCT05947669
Lead Sponsor	Odense University Hospital Collaborators: Aalborg University Hospital, Royal Marsden NHS Foundation Trust
Conditions	Colitis
Enrollment	195 participants
Start Date	2023-08-22
Primary Completion	2026-09 (estimated)
Study Completion	2028-09 (estimated)
Updated on ClinicalTrials.gov	2023-08-24