Phase 1 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 aged between 18 and 75 years (inclusive), of any gender
• People who have been diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) for at least 3 months, confirmed by tissue examination or a camera procedure looking inside the bowel
• People whose UC or CD is currently classified as moderately to severely active
• People whose condition has not responded to at least one previous treatment — such as anti-inflammatory tablets, steroid tablets, immune-suppressing medications, or biologic medicines — or who could not tolerate those treatments
• People who are currently taking certain UC or CD medications may still be eligible, provided those medications have been at a stable dose for a required period before the trial starts (confirm with trial site for specific timeframes)
• People who have recently stopped taking certain UC or CD medications must have stopped for at least 2 weeks before a pre-trial bowel examination
• People (and their partners) who are willing to use effective contraception from the start of screening until 3 months after the last dose of trial medication
• People who have read and understood the trial details — including its risks and benefits — and are willing to sign a consent form

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People whose bowel disease is limited only to the last 15 cm of the rectum near the anus
• People diagnosed with indeterminate colitis, radiation colitis, or colitis caused by reduced blood flow (ischemic colitis)
• People with serious bowel complications such as narrowing of the bowel, blockage, perforation, major bleeding from the lower bowel, abnormal tissue changes that could become cancerous, toxic megacolon, polyps in the rectum or colon, or anal conditions that the trial doctor believes could affect the trial results
• People who currently have a stoma, a surgically reconnected bowel after removal of part of the intestine, or a fistula, where the doctor believes surgery or medical intervention may be needed within 12 weeks of joining the trial
• People who have had a large portion of their small bowel removed (more than 100 cm), have been diagnosed with short bowel syndrome, or require feeding directly into a vein (total parenteral nutrition)
• People with a confirmed positive test for a bowel infection called Clostridium difficile (though rescreening may be possible after treatment — confirm with trial site)
• People with confirmed cytomegalovirus-related bowel inflammation who have not completed at least 3 months of adequate treatment and are not currently symptom-free
• People with certain active or chronic infections detected during screening, including active hepatitis, hepatitis B, hepatitis C, HIV, or syphilis (specific test result combinations apply — confirm with trial site)
• People with a history of active tuberculosis, or who test positive for latent (inactive) tuberculosis during screening, unless they agree to complete a preventive treatment course during the trial (certain medications such as rifampin must be avoided)
• People with a history of severe shingles or herpes simplex infections, such as herpes affecting the brain, widespread herpes simplex, or widespread shingles
• People who were hospitalised for a serious bacterial, fungal, or viral infection requiring intravenous antibiotics or antiviral treatment within the 2 months before the first dose
• People who received a live vaccine within 4 weeks before the first dose, or who plan to receive a live vaccine during the trial
• People who developed a significant infection during the screening period requiring antibiotic or antiviral treatment, including respiratory infections, herpes simplex, or shingles
• People with a serious or unstable major health condition affecting the kidneys, liver, blood, digestive system, hormones, lungs, mental health, nerves, immune system, or an active infection, where the trial doctor considers participation unsuitable
• People with chest pain (angina), irregular heart rhythm, or heart failure requiring medication, or with significant abnormalities found on a heart tracing (ECG) done during screening
• People with certain abnormal blood test results during screening, including liver enzyme levels, low blood counts (red cells, white cells, neutrophils, lymphocytes, or platelets), or raised bilirubin levels — specific thresholds apply (confirm with trial site)
• People with poorly controlled diabetes or diabetes that has led to serious complications such as eye or kidney damage
• People who have had a cancer diagnosis (including very early-stage cancer) or a blood or lymph system disorder within the 5 years before the first dose
• People who have received more than 2 classes of biologic medicines within 8 weeks or 5 half-lives (whichever is longer) before the first dose
• People who have taken certain immune-targeting medicines called JAK inhibitors or other small molecule inhibitors (other than those targeting TYK2 or TYK2/JAK1) within 4 weeks or 5 half-lives before the first dose, unless the required washout period has been met
• People who have previously been treated with a small-molecule drug that targets the same pathway (TYK2 or TYK2/JAK1) as the trial medication
• People who have received certain immune-modifying treatments — including faecal microbiota transplantation, cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, or similar medications — within 4 weeks before the first dose
• People who have taken any other experimental drug within 1 month or 5 half-lives (whichever is longer) before the first dose
• People who had surgery within 4 weeks before the first dose, or who are planning surgery during the trial
• People who received immunoglobulin or blood products within 4 weeks before the first dose
• People who used certain strong enzyme-affecting medications (such as rifampin, phenobarbital, carbamazepine, or phenytoin) within 4 weeks before the first dose
• People who are using certain local bowel treatments (enemas or suppositories), intravenous steroids, traditional Chinese medicine for UC or CD, anti-infective medicines, or anti-diarrhoea medications
• People who took anti-inflammatory pain medications (NSAIDs) within 1 week before the first dose, with exceptions for topical NSAIDs and low-dose aspirin taken for heart protection
• People who have had an organ transplant and require ongoing immune-suppressing medication
• People with a known allergy to any ingredient of the trial drug (TQH3906), or a history of severe drug allergies
• People with a history of substance misuse or a positive drug screening test
• People where the trial doctor identifies any other medical, psychological, or social reason that makes participation unsuitable

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