Phase 3 Crohn's Disease and Colitis Trial, Not Yet 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 18 or older, of any gender
• People who have had a confirmed diagnosis of Crohn's disease for at least 3 months, based on medical history, lab tests, endoscopy, and imaging
• People whose colonoscopy shows one or more ulcers in the small intestine or colon, with a disease activity score (SES-CD) of at least 3
• People who have previously tried and either did not respond to, or could not tolerate, at least one anti-TNF treatment (infliximab or adalimumab)
• People taking oral steroid tablets (such as prednisone) at a stable dose of up to 40 mg per day for at least 3 weeks before the study start, or who stopped taking steroids at least 3 weeks before the study start
• People who were taking infliximab must have stopped it at least 8 weeks before the study start; people who were taking adalimumab must have stopped it at least 4 weeks before the study start
• People who meet specific tuberculosis (TB) screening requirements, including no signs of active TB, a negative or appropriately managed TB test within 2 months before starting the study, and a clear chest scan within 3 months before starting (confirm with trial site for full details)
• Female participants who have a negative pregnancy test before the study and use reliable contraception throughout, or who are postmenopausal; male participants who also use reliable contraception
• People who have read, understood, and signed a consent form agreeing to take part in the study

Who may not be able to join:

• People whose Crohn's disease may require surgery, or who have conditions such as short bowel syndrome, significant bowel narrowing, or an active stoma that could affect how treatment results are measured
• People with a current or suspected abscess, unless a skin or perianal abscess was fully drained and treated at least 3 weeks before the study start, or an internal abdominal abscess was fully drained and treated at least 8 weeks before the study start with no further surgery expected
• People who have had bowel surgery or abdominal surgery within the 6 months before the study start, or who were hospitalised for a bowel blockage within the 3 months before the study start
• People who have used certain medications too close to the study start, including other experimental Crohn's treatments, intravenous steroids (within 3 weeks), immunosuppressant drugs such as azathioprine or methotrexate (within 4 weeks), or plasmapheresis (within 3 weeks)
• People who had a positive stool test for a bowel infection, including Clostridioides difficile, within the 4 months before screening, unless follow-up testing was negative and the infection has fully cleared
• People who received a BCG vaccine within the 12 months before screening, or any other live vaccine within 2 weeks after the study start
• People with a history of long-term or frequently recurring infections, such as chronic kidney infections, repeated chest or urinary tract infections, or persistent infected skin wounds
• People who currently have signs or symptoms of an infection, or who had a serious infection (including one requiring hospitalisation) or shingles (herpes zoster) within the 8 weeks before the study start
• People whose chest imaging shows signs of active tuberculosis or suspicious growths that could be cancer, unless clearly ruled out with supporting medical evidence
• People with a history of certain fungal infections (such as histoplasmosis or coccidioidomycosis) or serious opportunistic infections before screening
• People with a history of non-tuberculosis mycobacterial infection
• People with hepatitis B, hepatitis C, or HIV
• People with a diagnosis or history of heart failure or demyelinating disease (a condition affecting the nervous system)
• People with severe, progressive, or poorly controlled conditions affecting the kidneys, liver, blood, hormones, lungs, heart, nerves, or mental health, or those with lupus
• People who have had an organ transplant, except for a corneal transplant performed more than 3 months before screening
• People with lymphoma or other conditions affecting lymph tissue, or with signs that suggest such a condition may be present
• People with a current or past diagnosis of cancer of any kind
• People who have previously received allergy immunotherapy to prevent severe allergic reactions (anaphylaxis)
• People who are unable or unwilling to have multiple blood draws due to poor vein access or inability to tolerate the procedure
• People with a known allergy or sensitivity to ustekinumab, upadacitinib, or any of their ingredients
• People with significant substance misuse concerns (such as drugs or alcohol) at the time of screening or within the 12 months before the study start
• People who are currently taking part in, or plan to take part in, another clinical trial during the first 52 weeks of this study
• People where the trial doctor believes participation would not be in their best interest, or where a medical condition may interfere with the study assessments

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