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:

• Adults who are not pregnant or breastfeeding and have been diagnosed with ulcerative colitis (UC) that extends at least 15 cm inside the bowel, confirmed by a camera examination of the bowel and tissue sample, at least 3 months before the screening visit.
• People whose UC is moderately to severely active, based on specific scoring measures used by doctors to rate disease severity (confirm with trial site).
• People who may need a full bowel camera examination (colonoscopy) at screening if they have had widespread UC for more than 8 years, or left-sided UC for more than 12 years, and have not had a colonoscopy within the past year; those who have had one within the past year may use a shorter camera examination instead.
• People whose UC has not responded well enough to, or who could not tolerate, at least one of the following treatments at approved doses: certain anti-inflammatory tablets (5-ASA compounds or sulfasalazine), steroid tablets (such as prednisone or budesonide), immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate), or approved biological or targeted medicines including vedolizumab, ustekinumab, risankizumab, guselkumab, mirikizumab, ozanimod, or etrasimod — but who have not failed more than one of these advanced biological or targeted therapies.
• People who are currently taking certain UC medicines at stable doses may still be eligible, including anti-inflammatory tablets (stable for at least 2 weeks or stopped at least 2 weeks before the screening examination), low-dose steroid tablets (stable for at least 2 weeks or stopped at least 2 weeks before the screening examination), or immune-suppressing medicines (stable for at least 8 weeks or stopped at least 8 weeks before the screening examination).
• People of childbearing potential who are not pregnant, not breastfeeding, and who agree to use an acceptable form of contraception during the trial and for at least 28 days after the last dose of the trial medicine, and who have a negative pregnancy test within 24 hours before the first dose.
• People of childbearing potential who agree not to donate eggs for assisted reproduction during the trial and for 28 days after the last dose of the trial medicine.
• People who are able to fully participate in all parts of the trial and who understand and provide informed consent, or whose legal representative does so on their behalf.

Who may not be able to join:

• People with very severe UC involving at least 6 episodes of bloody diarrhoea per day along with certain other signs of serious illness, or where hospitalisation for UC may be imminent in the doctor's view.
• People who have had a large portion of their large bowel surgically removed (subtotal or total colectomy).
• People with short bowel syndrome, a stoma (ileostomy or colostomy), an ileoanal pouch, bowel fistulas, or a known fixed narrowing of the bowel causing symptoms.
• People with a history of toxic megacolon (a dangerous swelling of the bowel) or bowel perforation within the past 6 months.
• People diagnosed with Crohn's disease, indeterminate colitis, or other specific types of colitis that are not ulcerative colitis (such as ischaemic, radiation-related, microscopic, or infectious colitis), or who have abnormal precancerous changes in the bowel lining, or untreated bile acid malabsorption.
• People with uncontrolled liver disease related to primary sclerosing cholangitis.
• People who have had a cancer diagnosis within the past 5 years, with the exception of certain fully treated or removed skin cancers or cervical pre-cancer (confirm with trial site).
• People with a history of adenomatous polyps in the bowel that have not been removed.
• People with a history of, or signs suggesting, lymphoma or other diseases of the lymph system.
• People with severe heart disease classified as Class III or IV (confirm with trial site).
• People with significantly abnormal vital signs, physical examination findings, or heart rhythm test (ECG) results at screening, including certain heart rhythm abnormalities or conditions that increase the risk of heart rhythm problems.
• People with a history of bleeding disorders such as haemophilia or uncontrolled bleeding.
• People with a history of major neurological conditions including stroke, epilepsy, or diseases affecting the brain or nervous system.
• People at increased risk of serious infections, such as those with a known immune deficiency (including HIV), recent serious bacterial infections, or a history of organ or stem cell transplantation.
• People who test positive for tuberculosis (TB) at screening, unless they have a history of latent TB and are receiving or have completed appropriate treatment for it (specific rules apply — confirm with trial site).
• People who test positive for active hepatitis B virus infection (specific rules apply for certain test results — confirm with trial site).
• People who test positive for active hepatitis C virus infection (specific rules apply for certain test results — confirm with trial site).
• People with a confirmed bowel infection caused by Clostridioides difficile or other intestinal bacteria within 4 weeks before screening.
• People with a clinically active cytomegalovirus (a type of viral) infection.
• People with any other significant infection inside or outside the bowel, or a history of opportunistic infections, within 6 months before joining the trial.
• People with autoimmune conditions that require immune-suppressing treatment.
• People whose blood test results at screening fall outside certain ranges for red blood cells, white blood cells, platelets, or liver function markers (confirm with trial site for specific values).
• People whose UC has not responded adequately to more than one of the following advanced therapies: vedolizumab, ustekinumab, anti-IL-23 medicines, or S1PR modulators.
• People whose UC has not responded adequately to TNF inhibitors or JAK inhibitors.
• People currently taking certain UC medicines too close to the start of the trial, including biological therapies within 8 weeks or 5 half-lives (whichever is longer), S1PR modulators within 4 weeks or 5 half-lives (whichever is longer), intravenous antibiotics within 8 weeks, rectal treatments for UC within 2 weeks before the screening examination, regular high-dose anti-inflammatory pain medicines (NSAIDs), or products that may affect bowel movement within 2 weeks before joining.
• People who are unwilling to stop medications prohibited by the trial protocol during the study.
• People who have had a faecal microbiota transplant within 4 weeks before joining.
• People who have received a live or live-attenuated vaccine within 4 weeks before joining, or who plan to receive one during the trial.
• People who have had or plan to have major surgery requiring general anaesthesia within 8 weeks before or during the trial.
• People who have taken part in another clinical trial and received an investigational medicine within 4 weeks or 5 half-lives (whichever is longer) before joining.
• People who have previously enrolled in this same trial and received the trial medicine.
• People with a history of significant alcohol or drug misuse that, in the doctor's view, may affect their ability to follow study procedures.
• People with a known allergy or sensitivity to the trial medicine or any of its ingredients.
• People currently performing mandatory military service, deprived of their liberty, living in a residential care institution, or legally prevented from participating in a clinical trial.
• People who are an immediate family member or dependent of a staff member at the trial site who is involved in running this study.
• People with other serious medical or psychiatric conditions, or abnormal test results, that the doctor believes would increase risk or affect the reliability of the study results.

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