Phase 4 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 aged 18 to 75 years old at the time of giving consent.
• People who have been diagnosed with ulcerative colitis, confirmed by their medical history, a bowel camera examination (endoscopy), and tissue sample results (histology).
• People experiencing a severe flare of ulcerative colitis, meaning they have had 6 or more bloody bowel movements per day in the 7 days before the study start date, plus at least one of the following in that same period: a fever above 37.8°C; a heart rate of 90 beats per minute or higher; a low blood count (haemoglobin at or below 10.5 g/dL); a raised inflammation marker called ESR (at or above 30 mm/h); a raised inflammation marker called CRP (at or above 3.0 mg/dL); a raised stool inflammation marker called faecal calprotectin (above 782 mg/kg); or use of steroid tablets for 7 or more days in the month before consent at a dose of at least 20 mg per day.
• People who could become pregnant must have a negative pregnancy test (blood or urine) before joining.
• People who could become pregnant must intend to use at least one reliable method of contraception from the study start date through to at least 30 days after the last dose of the study drug or week 48, whichever is later.
• People joining the outpatient group must be under the care of a gastroenterologist connected to the University of Michigan.
• People who are able to swallow tablets and are willing to follow the study medication schedule.
• People who are willing and able to attend scheduled visits, complete daily bowel movement surveys, and follow all other study procedures.
• People who have read and signed a consent form confirming they understand what the study involves.

Who may not be able to join:

• People who have been receiving steroid medication through a drip (IV) continuously for more than 72 hours immediately before enrolment, equivalent to a total dose of 180 mg of IV methylprednisolone in the 3 days before enrolment.
• People who have previously taken the study drug upadacitinib (previous use of similar drugs such as tofacitinib, baricitinib, or filgotinib is permitted).
• People with a history of significant drug or alcohol misuse within the 6 months before the study start.
• People who have had two or more separate episodes of a painful nerve rash caused by the chickenpox virus (herpes zoster/shingles), or one or more episodes where the rash spread widely across the body.
• People who currently have a serious active infection, as assessed by the study team (confirm with trial site).
• People with active tuberculosis (TB) or untreated latent TB (inactive TB that has not been treated).
• People who have recently tested positive for COVID-19 must meet specific recovery criteria before joining — at least 5 days must have passed since a positive test for people with no symptoms, or for those with mild to moderate COVID-19, fever must have resolved for at least 24 hours without fever-reducing medication and other symptoms must have improved, or 5 days must have passed since the positive test, whichever is later (confirm with trial site).
• People who have had a stroke, heart attack, heart stent procedure, or heart bypass surgery within the past 6 months.
• People who have a known allergy or sensitivity to any of the following: methylprednisolone, prednisone, upadacitinib, or any of the ingredients in the study tablets (including colloidal silicon dioxide, hypromellose, iron oxide yellow and red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid, and titanium dioxide); people in the inpatient group who have a known sensitivity to cow's milk are also excluded, as cow's milk is a component of methylprednisolone.
• People who are currently pregnant or breastfeeding (borderline pregnancy test results require further testing as specified by the protocol).
• People who have received a live vaccine within 30 days before the first dose of the study drug, or who are expected to need a live vaccine during the study or within 30 days of completing it.
• People whose condition has progressed to toxic megacolon (a dangerous complication involving severe widening of the colon along with serious whole-body symptoms), as determined by the study and treatment team.
• People with an active CMV bowel infection (a viral infection affecting the bowel lining), unless the infectious disease team approves continued participation and antiviral treatment is started (confirm with trial site).
• People who have taken part in another clinical trial or received an experimental treatment within 30 days or five half-lives before the study start, whichever is longer.
• People with an active cancer, except for certain early-stage or localised skin cancers or cervical carcinoma in situ.
• People who have had their entire colon or most of their colon removed, have had certain bowel reconstruction surgeries (ileoanal pouch, Kock pouch, or ileostomy), or are planning major bowel surgery (partial colon removal is permitted).
• People with certain significant abnormalities in blood test results suggesting moderate or severe problems with the kidneys, blood, or liver (confirm with trial site for specific values).
• People with a history of liver cirrhosis (scarring of the liver) or current clinical evidence of it.
• People with inherited or acquired conditions that significantly increase the risk of blood clots (confirm with trial site for specific conditions); a past history of a blood clot that was triggered by a specific cause, or a recent blood clot currently being treated with blood thinners, does not automatically exclude someone.
• People with active hepatitis B infection where the hepatitis B surface antigen is detected along with detectable viral DNA and no treatment is in place (people with resolved past hepatitis B infection or those on suppressive therapy with low viral levels are not excluded).
• People with active hepatitis C infection, confirmed by detectable hepatitis C virus in the blood.
• People with HIV who have a CD4 immune cell count below 350 cells/µL, or who have AIDS (advanced immune deficiency with certain serious infections).
• People who have had a solid organ or bone marrow transplant within the past year, or who are expected to receive one within 6 months of joining the study.
• People with a history of a spontaneous tear or hole in the bowel wall (not caused by appendicitis or a physical injury), or those considered by the investigator to be at significantly increased risk of this happening.
• People who are currently taking, or expected to take during the study, certain medications that strongly affect how the body processes the study drug (known as strong CYP3A4 inducers or inhibitors); this also includes grapefruit and grapefruit juice.
• People with a condition that may affect how the body absorbs tablets taken by mouth, such as having had the stomach surgically removed or certain types of weight-loss surgery, as determined by the investigator (some procedures such as gastric banding are permitted).
• People with a history of certain other significant medical conditions as defined in the study protocol (confirm with trial site).

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