Phase 4 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 have signed a written consent form before any study procedures begin.
• People who are willing and able to attend all scheduled study visits, including camera examinations of the bowel (endoscopy) and filling in a daily diary.
• People who are willing to follow the contraception requirements set out by the trial (confirm with trial site for details).
• People aged between 18 and 75 years.
• People who have never previously taken the medicines azathioprine or 6-mercaptopurine (6-MP).
• People who have never previously been treated with "advanced therapies" such as biologics or similar newer medicines (confirm with trial site for specifics).
• People who were first diagnosed with ulcerative colitis (a type of inflammatory bowel disease) less than 12 months ago.
• People with active ulcerative colitis whose symptoms have not been controlled well enough by standard medicines (5-ASA or steroids), where those medicines have stopped working, or where those medicines caused unacceptable side effects.
• People who, if taking steroid tablets, have been on a stable dose of prednisone of 20 mg per day or less (or an equivalent steroid) for at least two weeks before the study start.
• People who, if taking a 5-ASA medicine by mouth, have been taking it for at least 8 weeks and at a stable dose for at least 2 weeks before the study start.
• People whose disease activity falls within a specific scoring range on a bowel disease activity scale called the Modified Mayo Score (a score of 5 to 9) (confirm with trial site).
• People whose bowel lining, as seen during an endoscopy, shows a certain level of inflammation on a scoring scale called the Endoscopic Mayo Score (a score of 2 or higher).
• People whose bowel tissue sample shows a certain level of inflammation on a scoring scale called the Robarts Histopathology Index (a score above 4).
• People who have raised levels of certain inflammation markers in their blood (CRP) or stool (faecal calprotectin above 250 µg/g).
• People whose ulcerative colitis affects at least the rectum and the lower part of the large bowel (at least 15 cm of the bowel).

Who may not be able to join:

• People with a very severe ("fulminant") form of ulcerative colitis that is not responding to steroids, or who need more than 20 mg of prednisolone (or equivalent) per day, or who need to be hospitalised due to their condition.
• People with complicated ulcerative colitis who have previously needed medicines called cyclosporine or tacrolimus.
• People who have taken a medicine called methotrexate (MTX) within the 8 weeks before the study start.
• People who have used rectal (inserted via the back passage) 5-ASA or rectal steroid treatments within 2 weeks before the study start.
• People with a history of cancer, except for certain common types of skin cancer (non-melanoma skin cancer).
• People who have planned or expected surgery around the time of joining the trial.
• People known to have a deficiency of an enzyme called thiopurine methyltransferase (TPMT), which affects how certain medicines are processed by the body.
• People with known inherited conditions affecting the way the body handles certain sugars, including galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
• People who have been diagnosed with Crohn's disease (a different type of inflammatory bowel disease).
• People who have been diagnosed with certain serious infections, including hepatitis B, hepatitis C, HIV/AIDS, or active tuberculosis (TB).
• People in whose blood active hepatitis B or hepatitis C virus is detected.
• People diagnosed with latent (inactive) tuberculosis who are not willing to complete the appropriate TB treatment.
• People who plan to receive a BCG vaccination or any live vaccine during the study period.
• People diagnosed with widespread fungal infections or parasitic infections.
• People with serious or unstable health conditions affecting the heart, brain, lungs, liver, kidneys, blood, hormone system, nerves, or other organs (not including ulcerative colitis), or with other cancers, that could affect safety or make it difficult to assess how well the treatment is working.
• People with a known allergy or serious sensitivity to any ingredient in the study medicine (mirikizumab), or who have previously had a severe allergic reaction to it.
• People who are pregnant, currently breastfeeding, or planning to become pregnant during the study.
• People who are employees of the pharmaceutical company running this study (Lilly) or employees of organisations involved in the study, or their immediate family members.
• People who have taken part in another clinical trial using an experimental medicine in the 12 weeks before screening, or who are currently enrolled in another clinical or medical research study that may conflict with this one.
• People who are unwilling or unable to use the data recording device to log daily information, or who are unable to complete other study procedures.
• People who are in institutional care under a legal or governmental order.

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