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 been diagnosed with ulcerative colitis (UC) for at least 3 months, confirmed by camera examination of the bowel and tissue samples.
• People whose UC is rated as moderately to severely active, based on specific scoring tools used by doctors during the screening process.
• People whose UC affects a section of the bowel at least 15 centimetres long, starting from the rectum and extending upward.
• People with long-standing UC covering most or all of the colon (more than 8 years) or the left side of the colon (more than 12 years) who have had a bowel cancer surveillance colonoscopy within the past 12 months.
• People with a family history of bowel cancer, personal risk factors for bowel cancer, age over 50, or other known risk factors who are up to date with bowel cancer screening.
• People who have tried at least one, but no more than two, TNFα blocker medications (a type of biologic treatment) and either did not respond well, stopped responding over time, or could not tolerate them — prior experience with this type of biologic is required (confirm with trial site regarding any exceptions).
• People taking corticosteroid tablets (such as prednisone up to 40 mg per day, or budesonide up to 9 mg per day) who have been on a stable dose for at least 2 weeks before their screening bowel examination, and who are willing to gradually reduce that dose during the trial.

Who may not be able to join:

• People experiencing a severe sudden flare of UC, or who have had large portions of the colon surgically removed.
• People with signs of an abdominal abscess, toxic megacolon (a dangerous swelling of the colon), a stoma bag, or a known fixed blockage of the intestine.
• People with short bowel syndrome.
• People whose bowel condition is not UC, but rather Crohn's colitis, indeterminate colitis, ischemic colitis, colitis caused by anti-inflammatory pain medications, radiation colitis, microscopic colitis, or other types of colitis not consistent with UC.
• People with a history of abnormal cell changes (dysplasia) in the lining of the colon, or untreated bile acid malabsorption.
• People with uncontrolled primary sclerosing cholangitis (a liver and bile duct condition).
• People who have signs of an active widespread infection at the time of screening (minor localised infections, such as a nail fungal infection, may be assessed individually by the doctor).
• People with active or latent tuberculosis (TB), including those with a history of TB or a positive TB test result during screening.
• People who test positive for hepatitis B virus.
• People who test positive for hepatitis C virus.
• People with a current or recent bowel infection (such as C. difficile) within 28 days before the first dose — although those who are treated and confirmed clear of infection may be reassessed (confirm with trial site).
• People with an active cytomegalovirus (CMV) infection at the time of screening.
• People who have taken certain immune-suppressing medications (such as azathioprine or methotrexate) within 4 weeks before the first dose, or stronger immunosuppressants (such as cyclosporine) within 8 weeks before the first dose.
• People who have taken medications, herbal products, or natural health products that affect a specific liver enzyme called CYP3A4 within 2 weeks before enrolment (confirm with trial site for exceptions).
• People who have received intravenous antibiotics within 8 weeks before enrolment, or rectal treatments for UC within 2 weeks before their screening bowel examination.
• People who regularly use anti-inflammatory pain medications (NSAIDs) daily for more than 2 consecutive weeks (occasional use and low-dose daily aspirin for heart protection may be permitted — confirm with trial site).
• People who have received a live virus or live bacterial vaccine within 4 weeks before enrolment, or who plan to receive one during the study or within 12 weeks after the last dose.
• People who have had a stroke, heart attack, or coronary stenting within the past 6 months.
• People with moderate to severe heart failure diagnosed within the past 6 months.
• People with a history of blood clots, such as deep vein thrombosis or pulmonary embolism.
• People with a known inherited condition that increases the risk of blood clotting.
• People with a history of lymphoma or other lymph system diseases, or symptoms suggesting such conditions (such as swollen lymph nodes or an enlarged spleen).
• People who have had major surgery requiring general anaesthesia within 3 months before screening, or who plan to have major surgery during the trial.
• People who have taken part in another investigational procedure within 4 weeks before screening that the doctor believes may affect the trial results.

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