Phase 2 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are aged 18 to 65 years old at the time of screening.
• Women who could become pregnant must agree not to donate eggs during the study and for 6 months after their last dose of the study drug.
• Women who could become pregnant must agree to use effective contraception throughout the study and for a set period after their last dose (15 weeks for one medication type, or 6 months for another, depending on which treatment group).
• Women who could become pregnant must have a negative pregnancy test (blood or urine) at screening.
• People with a confirmed diagnosis of ulcerative colitis (UC) made at least 3 months before screening, supported by a scope examination and, where available, a tissue sample result.
• People with moderate to severe UC, based on a specific scoring system called the Mayo scale (scores 7–12), where the disease has not responded well enough to standard treatments such as steroids or immunosuppressant medicines, or where the person could not tolerate those treatments, or where those treatments are not suitable for them.
• People already taking certain UC medicines (such as 5-ASA drugs, steroids, or immunosuppressants) may still be considered, provided the dose has been stable for at least 14 days before the study start date.
• All participants must provide signed, written consent to take part in the study and its planned procedures.

Who may not be able to join:

• People who have previously been treated with either of the study drugs (infliximab or ustekinumab).
• People with a known allergy or sensitivity to the study drugs or their ingredients.
• People with moderate or severe heart failure (classified as NYHA class III or IV).
• People with unstable coronary artery disease (a serious heart condition).
• People who have had a significant stroke, brain bleed, or mini-stroke within the past 24 weeks before screening.
• People with chronic (ongoing) respiratory failure.
• People with severe chronic kidney failure.
• People with severe chronic liver failure.
• People with a condition affecting the protective covering of nerve fibres (demyelinating syndrome), or symptoms that resemble such a condition.
• People with alcoholic liver disease or liver damage caused by alcohol use.
• People diagnosed with cancer at any point in the past 5 years (exceptions may apply for certain types of early-stage skin cancer or cervical carcinoma in situ — confirm with trial site).
• People whose UC has caused complications that require surgical or other urgent treatment.
• People who have had a severe flare of colitis, an abscess inside the abdomen, severe bowel distension, or a bowel perforation within the 12 weeks before the study start date.
• People who have previously had extensive removal of the large bowel, or who have a surgical pouch (J-pouch).
• People for whom surgery for their bowel disease is already indicated or suspected to be needed during the study.
• People with a history of unclassified colitis or colitis caused by reduced blood flow (ischemic colitis).
• People who have had an episode of bowel diverticulitis within 60 days before the study start date.
• People with currently active bowel polyps, or abnormal cell changes (dysplasia) in bowel tissue samples that have not been treated.
• People currently receiving nutrition through a tube or directly into a vein (enteral or parenteral nutrition).
• People who are pregnant or breastfeeding.
• People taking any medicines that are on the trial's prohibited medications list.
• People taking a daily steroid dose higher than 40 mg of prednisone (or equivalent) or budesonide MMX above 9 mg per day.
• People who have had a bone marrow transplant.
• People who have undergone a blood-filtering procedure called apheresis within the 12 months before the study start date.
• People who received certain other biological medicines and have not yet waited long enough for those medicines to clear from the body (confirm with trial site).
• People who have had an intestinal microbiota (gut bacteria) transplant within 8 weeks before signing consent to participate.
• People with active or latent tuberculosis (TB).
• People with HIV infection.
• People currently being treated for active chronic infections, including certain viral, bacterial, or fungal infections (such as CMV, HSV, HPV, or fungal infections).
• People who have had certain viral infections (including HSV, HPV, influenza, or COVID-19) within 12 weeks before the study start date, or who have a history of a severe or widespread HSV infection.
• People with a congenital (present from birth) or acquired immune deficiency condition.
• People who have received a live vaccine within 30 days before the study start date.
• People with hepatitis B (HBV) or hepatitis C (HCV) infection.
• People with significant abnormalities found on a chest X-ray or heart tracing (ECG).
• People with significantly abnormal blood test results, including problems with liver enzymes, bilirubin, kidney function, haemoglobin (a measure of anaemia), or counts of certain blood cells (white cells, lymphocytes, neutrophils, or platelets) — specific thresholds apply (confirm with trial site).
• People with a positive stool test showing a relevant bacterial or fungal infection, or a positive test for Clostridioides difficile bacteria.
• People taking any treatment not permitted under this study's rules.

Important: Always verify eligibility with the trial site directly before applying.