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:

• People aged 18 to 65 years old at the time of enrolment.
• People who have been diagnosed with Crohn's disease (CD), ulcerative colitis (UC), or chronic granulomatous disease (CGD) colitis, confirmed by a camera examination of the bowel (endoscopy) or medical imaging, with active disease shown on a colonoscopy at the start of the study.
• People whose disease activity scores fall within a moderate-to-severe range, as measured by specific scoring tools used by doctors for each condition (confirm specific score thresholds with trial site).
• People whose disease has not been adequately controlled by, has stopped responding to, or who could not tolerate at least one standard treatment, which may include steroids (such as prednisone), immune-suppressing medications (such as azathioprine or methotrexate), TNF-blocking medicines (such as infliximab or adalimumab), anti-integrin medicines (such as vedolizumab), JAK inhibitor medicines (such as tofacitinib), or certain anti-inflammatory biologics (such as risankizumab or guselkumab).
• People who have a regular primary care doctor.
• Male participants who agree to use contraception to prevent pregnancy in female partners from the start of treatment until at least 3 months after treatment ends.
• Female participants who are able to become pregnant must not be breastfeeding or pregnant, must not have had unprotected sex in the month before the study drug is given, and must agree to use two forms of contraception together (a barrier method with spermicide plus one of: hormonal contraception, surgical sterilisation, or an intrauterine device) from enrolment until at least 6 months after treatment ends, or remain completely abstinent.
• People who are currently taking certain medications may still be considered, provided those medications have been at a stable dose for the required period before the study begins, or have been stopped for the required period — the trial site will assess this on an individual basis.

Who may not be able to join:

• People who have had a significant active infection (such as a urinary tract infection or respiratory infection) within the three months before screening.
• People with a history of recurring or ongoing infections, including hepatitis B, hepatitis C, HIV, bacterial infections, widespread fungal infections, or syphilis.
• People who test positive for tuberculosis (TB) on a specific blood test (QuantiFERON-Gold), or who have received a TB vaccine within the 12 months before the study starts.
• People with a history of active TB, or whose chest X-ray shows signs of past TB infection, or who have active or chronic hepatitis B, hepatitis C, HIV, or serious opportunistic infections.
• People with a significant heart conduction problem on an ECG (heart tracing), as judged by a heart specialist.
• People who have used certain unapproved immune-modifying medications (such as low-dose naltrexone) within 90 days of starting screening, or within the last 30 days of the screening period (confirm with trial site).
• People with certain abnormal blood test results, including low white blood cell counts, low haemoglobin (anaemia), low platelets, or abnormal kidney, liver, or clotting test results (confirm specific values with trial site).
• People who take blood-thinning (anticoagulant) medications regularly.
• People whose stool test shows the presence of an infectious organism that could be causing their bowel symptoms.
• People with an active cytomegalovirus (CMV) infection detected in bowel tissue samples.
• People with a history of abnormal pre-cancerous cell changes (dysplasia) in the lining of the colon.
• People who have had bowel surgery (other than certain minor procedures around the back passage) within 6 months before the screening period begins.
• People whose bowel anatomy has been surgically altered in a way that prevents the use of standard disease activity measures, such as those who have had a stoma (ileostomy or colostomy) or partial bowel removal with reconnection.
• People with known or suspected short bowel syndrome.
• People who require feeding through a tube or directly into a vein.
• People with a current or past history of cancer, with the exception of certain treated skin cancers (non-melanoma) — people over 60, those with a long history of immune-suppressing treatment, or those who have had certain light-based skin treatments will be monitored closely.
• People who are unwilling or unable to follow the study requirements.
• People whose bowel disease is only in the small bowel or upper digestive tract, or only around the back passage, in areas that cannot be reached by a standard colonoscopy.
• People who are unwilling to stop using anti-inflammatory pain medications (NSAIDs or COX-2 inhibitors) during the study treatment period.
• People with uncontrolled diabetes.
• People taking anti-seizure medications such as valproic acid (e.g. Depakote).
• People with any other condition that the lead doctor considers would make participation unsafe.
• People who have taken part in another clinical trial within 8 weeks (or within 5 half-lives of the study drug used in that trial, whichever is longer) before the screening visit.

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