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 fully understand what the study involves, including its procedures and possible side effects, and are able to sign a written consent form agreeing to take part.
• Women who are not pregnant and not breastfeeding, and people of any gender who are willing to use reliable contraception from the screening stage until 3 months after the last dose, and who do not plan to donate sperm or eggs during the study or for 3 months after the last dose.
• People aged 18 to 75 years old (inclusive) at the time of signing the consent form.
• People who have been diagnosed with ulcerative colitis (a type of inflammatory bowel disease affecting the large intestine) for at least 3 months before the screening colonoscopy, and whose condition meets the specific criteria set out in the study protocol.
• People taking certain ongoing medications may still be eligible, provided their situation meets specific requirements set out in the study protocol (confirm with trial site).
• People who have stopped taking certain medications may still be eligible, provided the timing and circumstances meet specific requirements set out in the study protocol (confirm with trial site).

Who may not be able to join:

• People who have been diagnosed with, or are suspected of having, Crohn's disease, or certain other bowel or intestinal conditions such as ischemic colitis, toxic megacolon, bowel perforation, abdominal abscess, or bowel fistulas, among others (confirm full list with trial site).
• People who have been diagnosed with abnormal cell changes (dysplasia) in the gastrointestinal tract that have not been fully treated and cleared.
• People who have already had surgery specifically for ulcerative colitis, or any other major bowel surgery requiring general anaesthetic, or who are likely to need such surgery during the study.
• People who have a current active intestinal infection, or who had a Clostridium difficile infection (a type of bacterial gut infection) or other intestinal infection within 30 days before the screening procedure, or who tested positive for such infections during screening.
• People who have ongoing or long-term infections, or active viral infections, that the study doctor considers make participation unsafe.
• People who are unable to swallow or absorb oral (by-mouth) medications due to severe malnutrition, illness, or surgery, or who are currently receiving or plan to receive nutrition delivered directly into the bloodstream (called total parenteral nutrition) during the study.
• People who have previously received certain treatments specified in the study protocol (confirm with trial site).
• People who have had recurrent or widespread herpes zoster (shingles) infections, or cytomegalovirus infection, even if it only happened once.
• People who have certain tuberculosis-related risk factors as defined in the study protocol (confirm with trial site).
• People who have certain other infections as defined in the study protocol (confirm with trial site).
• People who are known to be allergic to the study drug or any of its ingredients, or who have a history of multiple drug or food allergies.
• People who have unstable or poorly controlled serious medical conditions affecting areas such as the blood, heart, liver, lungs, kidneys, mental health, or nervous system, among others, that the study doctor considers would make participation unsafe (confirm full list with trial site).
• People who have another illness that, in the study doctor's opinion, is likely to require treatment with steroid medications during the study (for example, moderate to severe asthma).
• People who have had major surgery (excluding minor procedures such as needle biopsies) or serious physical trauma within 28 days before being assigned to a study group, or who are likely to need such surgery during the study.
• People who have had any cancer diagnosis within the past 5 years, except for certain successfully treated skin cancers (specifically non-melanoma skin cancer, basal cell carcinoma, or localised cervical carcinoma in situ).
• People whose blood test or other screening results fall outside the acceptable ranges specified in the study protocol (confirm with trial site).
• People with high blood pressure that remains poorly controlled (at or above 160/100 mmHg) despite taking blood pressure medication at the time of screening.
• People with a significantly abnormal heart rhythm test (ECG) at screening, including a specific electrical measurement (QTcF) that is above 450 milliseconds for males or above 470 milliseconds for females.
• People who have difficulty with blood draws, or who have a history of fainting during injections or a fear of blood.
• People who have medical reasons that make a colonoscopy unsafe, such as bowel fistulas, recent abdominal surgery, severe blood clotting problems, large abdominal aneurysms, or other conditions the study doctor considers to significantly raise the risk of complications from the procedure.
• People who, in the study doctor's judgement, have had a problem with alcohol or drug use in the 3 months before screening. Alcohol misuse in this context is defined as drinking alcohol at least twice a day or more than 14 units of alcohol per week.
• People who have taken part in another clinical trial of a drug or medical device within 30 days before screening and have already received that study treatment, or who are currently participating in another clinical trial of a drug or medical device.
• People who the study doctor considers unsuitable for any other reason, including those unable or unwilling to follow the study requirements.

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