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 who were male or female at birth, aged 18 to 75, who are able to understand and sign the consent form before any study procedures begin
• People who are able and willing to attend study visits and follow the study procedures as required
• People who have a confirmed diagnosis of Crohn's disease (CD), supported by camera examination of the gut (endoscopy) and tissue sample (biopsy) reports
• People whose Crohn's disease is moderately to severely active, based on specific scoring tools that measure symptoms and gut inflammation (confirm with trial site)
• People whose Crohn's disease has not responded well enough to at least one previous treatment — such as steroids, immune-suppressing medicines, biologic medicines, or JAK inhibitor medicines — or who could not tolerate those treatments (note: failing only a medicine called 5-ASA does not count)
• Women who could become pregnant, and men whose partners could become pregnant, who agree to follow the contraception requirements set out in the study protocol
• People who are covered by health insurance, where this is required by the country or region where the trial is taking place
• People who are able and willing to follow standard sun protection recommendations during the study

Who may not be able to join:

• Women who are pregnant or breastfeeding at the time of screening, who plan to become pregnant during the study, or men whose partners plan to become pregnant during the study
• People currently diagnosed with ulcerative colitis or indeterminate colitis (a related but different bowel condition)
• People whose Crohn's disease does not involve the small intestine (ileum) or large intestine (colon)
• People with an untreated active fistula (an abnormal channel from the bowel) or abscess (a pocket of infection) around the back passage or outside the body — though stable fistulas with minimal drainage and abscesses that have been properly drained and treated may be considered (confirm with trial site)
• People with a bowel narrowing (stricture or stenosis) that is causing symptoms and cannot be passed through with an endoscope
• People with a current stoma (a surgically created opening in the abdomen) or an ileoanal pouch
• People who are missing more than two of the five main sections of the bowel due to surgery
• People who have had more than 100 cm of small bowel removed in total across previous surgeries
• People who have had bowel surgery within the 3 months before the study start date
• People who may need bowel surgery while taking part in the study
• People currently taking medicines for Crohn's disease that are not allowed under the study protocol
• People who have previously been treated with natalizumab or similar medicines that work on the same pathway (α4β1 integrin)
• People who have tried and not responded to more than three advanced therapies for Crohn's disease, or more than two different types of advanced therapies
• People with a current or past cancer, including a type of skin cancer called nonmelanoma skin cancer — though people who have been cancer-free for 5 or more years may be considered (confirm with trial site)
• People with a history of colon cancer, abnormal precancerous growths (dysplasia) in the colon, or certain types of bowel polyps, or in whom these are found during the screening endoscopy
• People with a history of, or newly diagnosed with, certain liver conditions including primary sclerosing cholangitis, autoimmune hepatitis, or primary biliary cirrhosis
• People who have been hospitalised for a serious illness (not related to Crohn's disease) in the 4 weeks before screening
• People with ongoing serious or repeated infections, or a history of certain unusual infections while not on immune-suppressing treatment
• People who have had a reactivation of the shingles virus (herpes zoster) in the 2 months before screening
• People with an active infection at the time of screening, or who have been hospitalised or treated with intravenous antibiotics for an infection in the month before or during screening
• People with a positive stool test for certain gut pathogens or a positive test for a gut infection called Clostridioides difficile (C. difficile) at screening
• People living with HIV
• People with an active or ongoing hepatitis B infection detected through blood tests at screening
• People with an active or ongoing hepatitis C infection — though people who were successfully treated at least 1 year ago with no detectable virus may be considered (confirm with trial site)
• People with active tuberculosis (TB) or untreated latent (inactive) TB
• People with uncontrolled heart disease affecting blood supply to the heart, or a history of heart failure
• People with a personal or family history of a heart rhythm condition called long QT syndrome, or abnormal QT readings on a heart trace (ECG) at screening
• People with a history of a serious abnormal heart rhythm called torsade de pointes
• People with significant ongoing problems affecting the lungs, liver, kidneys, brain, or nervous system
• People who have received a live vaccine within 3 months before screening, or who plan to receive one during the study
• People with acute or chronic inflammation of the pancreas (pancreatitis)
• People whose blood test results during screening fall outside the required ranges — including low red blood cells, low white blood cells, low platelets, reduced kidney function, or raised liver markers (confirm specific values with trial site)
• People who have not completed the required washout period (a period of stopping certain medicines before joining) prior to the screening endoscopy
• People who have taken part in another clinical trial or used an experimental medicine within 3 months, or within 5 half-lives of that medicine, before the study start date — whichever is longer
• People who have previously been treated with the study medicine obefazimod, or who are known to be allergic to it or any of its ingredients
• People with a current problem with illicit drug or alcohol misuse or dependence
• People who are under a legal order that places them in an institution
• People who, in the opinion of the study doctor, have any condition that could affect their safety or ability to follow the study requirements

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