Phase 4 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:

• You are between 18 and 70 years old.
• You have been diagnosed with active Crohn's disease, confirmed by a specific type of camera examination of the gut (endoscopy) and blood or stool tests, or imaging scans.
• Your Crohn's disease symptoms score above a certain level on a standard measurement scale used by doctors (confirm with trial site for exact score details).
• You previously tried a type of medication called a TNF inhibitor, but it did not work well enough or stopped working over time.
• You have been taking a medication called ustekinumab at the standard dose for at least 16 to 24 weeks, but your Crohn's disease is still active.
• You are willing and able to sign a consent form and follow the study's requirements throughout the trial.
• A doctor has reviewed your overall health — including blood tests, a physical exam, a chest X-ray, and a heart tracing (ECG) — and considers you generally healthy enough to participate.

Who may not be able to join:

• You have a known allergy to upadacitinib (UPA) or ustekinumab (UST), or to any of their ingredients.
• You have untreated or unresolved pre-cancerous changes (high-grade dysplasia) or cancer of the colon.
• You have an active infection right now, such as pneumonia, a kidney infection, or shingles, or you have a long-term (chronic) infection that the doctor feels makes participation unsafe.
• You currently need surgery for your Crohn's disease, or it is expected that you will need surgery during the study.
• You have been found to have blood clots, based on an ultrasound scan of your legs or a blood test (D-dimer).
• You have a history of lymphoma or other diseases affecting the lymph system, or you currently have swollen lymph nodes or an enlarged spleen that may suggest such a condition.
• You have a condition that weakens your immune system, such as a condition you were born with, HIV infection, or you have received an organ transplant.
• You are pregnant, or a pregnancy test at the start of the study comes back positive.
• You are currently breastfeeding or planning to become pregnant during the study.
• You have used illegal drugs or misused alcohol within the past year before joining the study.
• The doctor running the trial decides, for any reason, that the study is not suitable for you.

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