Phase 2 Crohn's Disease and Colitis Trial, Not Yet Recruiting

Written by an AI model from the 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 able to understand the trial and are willing to give their consent and follow the trial's procedures.
• People who were assigned male or female at birth, of any gender identity, aged 18 to 75 years old at the time of giving consent.
• People who are postmenopausal, have had a sterilisation procedure, are not sexually active, or are using two approved forms of contraception (including one physical barrier method plus one highly effective method). Women who could become pregnant must also not be pregnant or breastfeeding at the time of the trial.
• People who have a confirmed diagnosis of ulcerative colitis (UC), backed up by camera examination of the bowel and tissue samples, made at least 4 months before the screening visit.
• People whose UC is classed as moderately to severely active, based on a specific scoring system used in this trial (confirmed during a central review of the screening bowel examination).
• People whose UC affects an area of the bowel that extends more than 15 cm from the back passage, as seen during the screening bowel examination.
• People whose UC has not responded well enough to between 1 and 2 previously approved biological or advanced UC medicines — at least one of which must have been an anti-TNF therapy — either because the medicine stopped working or never worked well enough at the doses approved for UC.
• People who have previously had an inadequate response to, lost response to, or could not tolerate standard UC medicines such as corticosteroids, 5-ASA medicines, or other immune-suppressing treatments.
• People who have stopped any previous treatment (including any experimental medicines) at least 4 weeks or 5 half-lives before screening, whichever is the longer period, or who have no active trace of that medicine remaining in their system at the start of screening.
• People whose blood test results at screening fall within the following ranges: haemoglobin at least 8 g/dL; white blood cell count at least 3×10³/μL; neutrophil count at least 1.5×10³/μL; platelet count at least 100,000/μL; kidney function markers within acceptable limits; liver enzyme levels no more than twice the upper limit of normal; and bilirubin levels within specified limits depending on whether or not the person has a condition called Gilbert's syndrome (confirm with trial site).

Who may not be able to join:

• People with significant abnormal medical history or abnormal results from physical examination, heart trace (ECG), or blood tests at screening that the investigator considers likely to affect the trial's safety or results.
• People who have had surgery (such as stomach bypass) or have a medical condition that may significantly affect how oral medicines are absorbed into the body.
• People who have been hospitalised for a severe UC flare requiring intravenous corticosteroids within the 12 weeks before screening.
• People who currently have, or have recently had (within 6 months before screening), a very severe bowel condition such as fulminant colitis, toxic megacolon, or a hole in the bowel wall.
• People where the investigator believes a surgical removal of the colon (colectomy) is likely to be needed within 12 weeks of starting the trial medicine.
• People whose UC is limited to only the rectum or the right side of the colon.
• People who have, or have had, a bowel fistula (an abnormal channel) consistent with a condition called Crohn's disease.
• People with a history of ischemic colitis (reduced blood flow to the bowel).
• People with a history of indeterminate colitis or microscopic colitis.
• People with a history of radiation colitis (bowel inflammation caused by radiation treatment).
• People with a history of Crohn's disease.
• People with a history of colonic stricture (a narrowing of the bowel).
• People who test positive for a bowel infection called Clostridioides difficile, a bacterial infection requiring antibiotic treatment, or parasites at screening.
• People who have had extensive removal of the colon or a full or near-full colectomy that would prevent the trial team from properly assessing the effect of the trial medicine.
• People who currently have or have had bowel polyps or abnormal cell changes (dysplasia) in the colon that have not been fully removed and confirmed clear — although people with a past history of polyps that have been completely removed and are confirmed clear at screening may still be considered eligible (confirm with trial site).
• People with any current cancer that the investigator does not consider to be in full remission, except for certain fully removed and resolved skin cancers. Any previous cancer must have been in remission for more than 2 years before screening.
• People who have previously been treated with more than 2 approved biological or advanced UC therapies at doses approved for UC.
• People who have received medicines that deplete certain immune cells (B or T cells, such as rituximab) within 12 months before the first dose of trial medicine.
• People who have active or at-risk hepatitis B virus infection, hepatitis C virus infection (unless fully cleared and documented for more than 2 years), or HIV antibodies detected at screening.
• People with severe, progressive, or uncontrolled disease affecting the kidneys, liver, blood, hormones, lungs, heart, nerves, or brain.
• People with a history of, or current, unstable heart disease or severe heart failure.
• People with a history of alcohol or drug misuse within 1 year before screening that the investigator believes would affect their ability to follow the trial requirements.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
• People who are receiving nutrition through a tube or through a drip into the bloodstream.
• People with bleeding disorders or recent use of blood-thinning medicines that the investigator considers would make it unsafe to perform the bowel examination and tissue sampling required by the trial.
• People who are currently taking certain medicines that interact with specific drug transport proteins in the body (including medicines such as amiodarone, clarithromycin, cyclosporine, ketoconazole, ritonavir, verapamil, tacrolimus, or gefitinib) (confirm with trial site).
• People with any other condition that would prevent them from safely and properly participating in the trial, including any known allergy to the trial medicine.

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