Phase 2 Crohn's Disease and Colitis Trial, 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 willing to take part voluntarily and sign a consent form.
• People aged 18 to 75 years old at the time of signing the consent form.
• People who have been diagnosed with ulcerative colitis (UC) for at least 3 months, with the diagnosis supported by colonoscopy and tissue sample results.
• People whose UC is currently active, based on a specific scoring system that measures bleeding, bowel movement frequency, and colonoscopy findings, reaching a defined level of disease activity (confirm with trial site).
• People whose UC affects an area of the bowel beyond just the rectum, starting at least 15 cm from the back passage, as confirmed by colonoscopy.
• People whose UC has not responded well enough to at least one previous treatment, or who had to stop a previous treatment due to side effects — previous treatments may include aminosalicylates (such as sulfasalazine or 5-ASA), oral steroids, azathioprine or 6-mercaptopurine, certain biologic medicines (such as infliximab, adalimumab, or vedolizumab), JAK inhibitor medications, certain interleukin inhibitors, or S1P receptor modulator medications.
• People currently taking steroid tablets for UC at a stable, low dose for at least 2 weeks before the screening colonoscopy, where the dose meets specific limits (confirm with trial site).
• People currently taking aminosalicylate medicines (such as sulfasalazine or 5-ASA) at a stable dose for at least 2 weeks before the screening colonoscopy, with the expectation that the dose remains stable throughout the study.
• People who are able and willing to use reliable contraception throughout the study and for 3 months after the last dose — this applies to women who are able to become pregnant and to men who have not had a vasectomy.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People with a known allergy to any ingredient in the study drug INT-210.
• People who are suspected or confirmed to have Crohn's disease, unclassified colitis, severe sudden-onset colitis, toxic megacolon, a hole in the bowel wall, microscopic colitis, colitis caused by reduced blood flow, or colitis caused by radiation treatment.
• People who have already had surgery for UC, or who are planning UC-related surgery such as removal of part or all of the large bowel or creation of a stoma.
• People found to have certain types of pre-cancerous growths or abnormal cells in the colon, including large polyps (10 mm or more), polyps with a certain tissue structure, or growths with high-grade abnormal cell changes.
• People with a liver condition called primary sclerosing cholangitis.
• People who have had problems with alcohol or drug misuse or dependence within the past year.
• People who have had major surgery within the past 6 months, or who are planning surgery during the study period.
• People who have had a heart attack, stroke, mini-stroke, serious blood clots, significant heart rhythm problems, unstable chest pain, heart bypass surgery, or severe lung-related heart or blood pressure conditions within the past 6 months.
• People with serious medical conditions affecting the heart, liver, hormonal system, digestive system, metabolism, nervous system, lungs, or mental health that could affect safety or the study results.
• People who have previously tried two or more types of biologic or targeted small molecule treatments for UC (such as anti-TNF medicines, anti-integrin medicines, anti-IL-12/23 medicines, JAK inhibitors, or S1P receptor modulators) and whose UC was assessed by the treating doctor as having failed to respond to both.
• People who have recently taken certain medicines that may interfere with the study, including anti-inflammatory drugs (other than low-dose aspirin for heart protection or short-term paracetamol), probiotics, fish oil supplements, JAK inhibitors, Chinese herbal medicines, or bowel-related immune therapies — specific time periods before joining apply to each medicine (confirm with trial site for exact timeframes).
• People who have recently used immune-suppressing medicines such as azathioprine, 6-mercaptopurine, cyclosporine, methotrexate, mycophenolate, tacrolimus, or sirolimus within 4 weeks before joining.
• People who have recently used steroid injections into a vein within 4 weeks, or steroid or 5-ASA enemas or suppositories within 2 weeks before joining.
• People who have recently used TNF-blocking medicines or interferon within 8 weeks, or S1P receptor modulators within 10 weeks, or vedolizumab or IL-12/23 blocking medicines within 12 weeks before joining.
• People who have used the medicine rituximab within the past year.
• People who have recently used any other experimental or approved immune-suppressing medicines within 8 weeks or 5 drug half-lives before joining (whichever is longer).
• People who test positive for tuberculosis (TB), or whose chest scan or other test suggests possible active TB infection.
• People with a history of recurring serious fungal infections or other ongoing infections; those who have had shingles or cytomegalovirus infection within the past 8 weeks; those with a confirmed bowel infection (such as C. difficile) within the past 30 days; or those who currently need infection-treating medicines.
• People who have a condition likely to require steroid tablet treatment during the study, such as moderate to severe asthma, severe eczema, or rheumatoid arthritis.
• People who have had a cancer diagnosis within the past 5 years, except for certain types of fully treated skin cancer; or those whose cancer screening results did not clearly rule out cancer.
• People with conditions that may affect how the body absorbs oral medicines, such as having had part of the stomach removed or certain types of weight-loss surgery (though people who have had only a gastric band procedure may still be considered eligible — confirm with trial site).
• People who have had small bowel or colon surgery and have signs of abnormal cell changes or bowel narrowing.
• People whose blood test results during screening fall outside acceptable ranges — this includes low red blood cells, low white blood cells, low platelets, abnormal liver function markers, abnormal kidney function, or evidence of active hepatitis B, hepatitis C, or HIV infection.
• People with a positive stool test for bowel infection-causing organisms during screening.
• People with a significant abnormality on their heart tracing (ECG) during screening that the treating doctor considers a safety concern.
• People who have received a live vaccine within the past 3 months before joining, or who plan to receive a live vaccine during the study.
• People whom the trial doctor considers unsuitable for participation for any other reason.

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