Phase 2 Crohn's Disease and Colitis Trial, Not Yet 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 given written agreement to participate in the trial
• People aged between 18 and 75 years old
• People who have been diagnosed with Crohn's disease for at least 6 months, whose symptoms have not improved (or came back) after trying at least one advanced treatment such as adalimumab, infliximab, or similar medicines, or who cannot tolerate these treatments, and whose doctors are considering surgery or a change in medication as the next step
• People whose Crohn's disease is currently active, as measured by specific disease activity scores used by the trial team
• People who have previously used certain medicines for Crohn's disease may still be considered, as long as enough time has passed since stopping them (for example, at least 8 weeks since stopping certain injected or infused medicines)
• People currently taking certain immune-suppressing medicines (such as azathioprine, mercaptopurine, or methotrexate) may be eligible if they have been on a stable dose for at least 4 weeks before the trial starts
• People who recently stopped azathioprine, mercaptopurine, or methotrexate, as long as it has been stopped for at least 4 weeks before the trial starts
• People taking oral anti-inflammatory medicines (such as 5-ASA compounds) or low-dose oral steroids (no more than 20mg per day of prednisone or equivalent), provided the dose has been stable for at least 4 weeks before the trial starts
• People taking budesonide, provided the dose has been stable for at least 2 weeks before the trial starts
• People who recently stopped oral 5-ASA compounds or oral steroids (including budesonide), as long as they have been stopped for at least 2 weeks before the trial starts
• People who have stopped certain other medicines before the trial starts, including: biological medicines (at least 8 weeks prior), certain immune-suppressing medicines like cyclosporine or tacrolimus (at least 4 weeks prior), JAK inhibitor medicines like upadacitinib (at least 4 weeks prior), and various other treatments including rectal steroids, rectal 5-ASA, intravenous steroids, intravenous nutrition, and antibiotics used for Crohn's disease (at least 2 weeks prior)
• People who have had a colonoscopy within the past 90 days showing no signs of abnormal cell changes or cancer in the colon
• People who are able to have children and are willing to use reliable contraception throughout the trial

Who may not be able to join:

• People who have not given informed consent
• People who are pregnant, breastfeeding, or women of childbearing potential without a confirmed negative pregnancy test
• People who have had a significant heart or other serious medical condition within the six months before the trial starts (confirm with trial site)
• People with confirmed HIV, Hepatitis B, or Hepatitis C infection
• People with certain abnormal liver blood test results at the time of screening
• People with certain abnormal results on routine blood tests, including very low haemoglobin (low red blood cells), abnormal platelet counts, reduced kidney function, or poorly controlled blood sugar levels (confirm with trial site for specific cut-off values)
• People with abnormal blood clotting test results at screening
• People with significantly abnormal vital signs before the trial starts, such as very high or low blood pressure, abnormal heart rate, abnormal breathing rate, fever, or low blood oxygen levels (confirm with trial site for specific values)
• People with a history of cancer, including melanoma, within the past 5 years (except for certain minor skin cancers)
• People diagnosed with ulcerative colitis or indeterminate colitis (a type of bowel disease that is not clearly defined)
• People with a suspected or confirmed abscess (pocket of infection) inside the abdomen or around the anus
• People with certain other types of bowel inflammation, such as microscopic, ischemic, or infectious colitis
• People with abnormal or pre-cancerous tissue found in the colon on biopsy
• People with evidence of a hole (perforation) in the colon
• People with a narrowing in the colon that is too tight for a standard colonoscope to pass through
• People who have had three or more previous surgeries to remove part of the small bowel
• People who already have a stoma (an opening in the abdomen for waste removal)
• People who have had a severe episode of colon bleeding requiring emergency surgery in the six months before screening
• People with severe, rapidly worsening colitis that requires emergency surgery
• People with an active Clostridioides difficile (C. diff) bowel infection
• People with an active Cytomegalovirus (CMV) infection of the colon, confirmed by biopsy within the past 90 days
• People with active or latent (hidden/inactive) tuberculosis
• People who are unable to reduce or stop taking corticosteroids
• People with a liver condition called primary sclerosing cholangitis
• People with a history of, or current, alcohol or drug misuse, or use of medical marijuana within the 90 days before screening
• People with a known allergy to local anaesthetics
• People currently using blood-thinning medicines such as warfarin, heparin, or clopidogrel
• People with a known history of conditions that cause the blood to clot too easily
• People whose heart tracing (ECG) shows an abnormal heart rhythm (other than a mildly elevated heart rate within the allowed range)
• People who have participated in another clinical trial or used an experimental treatment within 6 months before the trial starts

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