Ulcerative Colitis Acute
Upadacitinib Plus Steroids for Acute Severe Ulcerative Colitis
This study is investigating the early efficacy and safety of upadacitinib plus corticosteroids versus corticosteroids alone in hospitalized and outpatient adults with acute severe ulcerative colitis.
Registry title: Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- Oral Upadacitinib or Intravenous Methylprednisolone
- Design
- Randomized · Triple
- Central study contact
- Queen Saunyama734-647-2564saunayma@umich.edu
- Sponsor
- Berinstein, Jeffrey
Research question
Does adding upadacitinib to corticosteroids improve early clinical response without rescue therapy or colectomy, compared with corticosteroids alone, and what safety events occur?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 75.
- The study is looking for people with ulcerative colitis confirmed by clinical history, endoscopy, and histology.
- The study is looking for people meeting its definition of acute severe ulcerative colitis, including at least six bloody bowel movements daily plus another specified clinical or laboratory feature.
- The study includes both hospitalized participants and outpatients who do not require hospital admission.
- Outpatient participants must be under the care of a University of Michigan-affiliated outpatient gastroenterologist.
Participation overview
What participation may involve
Participation has eligibility assessment, acute induction, post-acute induction through week 8, and maintenance through week 48. Assigned treatment depends on inpatient or outpatient status and randomized study group. What participation may involve: - During acute induction, participants receive corticosteroids plus either oral upadacitinib or oral upadacitinib placebo. - The acute induction phase lasts five days for outpatients and from day 0 until discharge, up to ten days, for inpatients. - If the condition does not improve or worsens after three days, the assigned treatment is revealed and rescue therapy is started. - After acute induction, participants take a prednisone taper; the upadacitinib groups also receive upadacitinib during post-acute induction and may continue it during maintenance. - Participants must be willing to complete scheduled visits, laboratory tests, daily bowel-movement symptom surveys, and other study procedures. The registry describes study phases through week 48 and safety follow-up outcomes through week 52, or day 365.
Study interventions
What participants may receive or do
- Oral Upadacitinib: Participants assigned to upadacitinib receive 45 mg during acute and post-acute induction. Unrescued participants who do not undergo colectomy may continue through week 48, with the dose adjusted among 45 mg, 30 mg, or 15 mg according to symptoms and inflammatory biomarkers.
- Intravenous Methylprednisolone: This corticosteroid is given intravenously at 60 mg daily, in divided or full doses. Inpatients receive it in the hospital, while outpatients may receive it at an infusion center.
- Oral Upadacitinib Placebo: This placebo is used during the blinded acute induction phase in the corticosteroid comparison groups. It is stopped at hospital discharge for inpatients or after day 5 for outpatients.
- Oral prednisolone Taper: After acute induction, participants taper oral prednisone. The corticosteroid-only groups start at 40 mg and reduce by 5 mg weekly; the upadacitinib groups follow a specified two-week taper from 40 mg to 5 mg.
- Oral Prednisone - Hospital Dose Steroids: Outpatients may receive oral prednisone 75 mg daily for five days instead of intravenous methylprednisolone at an infusion center, followed by a prednisone taper.
Study design
How the comparison works
This is a phase 4, single-center, randomized parallel-group treatment study with separate inpatient and outpatient groups. It is blinded during acute induction and open label after specified unblinding events. Participants are randomly assigned to parallel groups receiving upadacitinib plus corticosteroids or upadacitinib placebo plus corticosteroids within the inpatient or outpatient cohort. Participants, care providers, and investigators are blinded during acute induction. Treatment is revealed if rescue therapy begins, at discharge for unrescued inpatients, or on day 5 for unrescued outpatients; later phases are open label. The comparison groups receive corticosteroids plus upadacitinib placebo during acute induction, followed by a prednisone taper and maintenance therapy selected through usual care. An oral upadacitinib placebo is used only during the acute induction phase in the corticosteroid comparison groups and is stopped at discharge for inpatients or after day 5 for outpatients.
Reported activities
Procedures and tests
- Screening includes confirming ulcerative colitis through clinical history, endoscopic appearance, and histology.
- Recent bowel-movement frequency and visible rectal bleeding are assessed to confirm the study's acute severe ulcerative colitis definition.
- Clinical or laboratory evidence used for the severity definition may include temperature, pulse, hemoglobin, erythrocyte sedimentation rate, C-reactive protein, fecal calprotectin, or recent oral corticosteroid use.
- People of childbearing potential require a negative laboratory-based urine or serum pregnancy test.
- Participants complete daily bowel-movement symptom surveys.
- Laboratory testing and clinical symptom assessments are used during the study, including C-reactive protein and inflammatory biomarkers.
- Adverse events, serious infections, and specified adverse events of special interest are assessed during acute induction and later follow-up.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 75 years old when they consent.
- Ulcerative colitis must be supported by a typical clinical history and characteristic endoscopy and histology findings.
- Participants must have at least six bowel movements daily with visible blood during the seven days before day 0, plus at least one specified clinical, laboratory, biomarker, or corticosteroid-use feature.
- A person of childbearing potential must have a negative laboratory-based urine or serum pregnancy test.
- A person with reproductive and childbearing potential must intend to use at least one effective birth-control method for the specified study period.
- Outpatient participants must be under the care of a University of Michigan-affiliated outpatient gastroenterologist.
- Participants must be able to take oral medication and agree to follow the study regimen.
- Participants must be willing and able to complete scheduled visits, treatment, laboratory tests, daily symptom surveys, and other study procedures.
Possible reasons someone may not be able to join
- More than 72 continuous hours of intravenous corticosteroids immediately before enrollment is exclusionary.
- Previous upadacitinib exposure is exclusionary, although prior use of other Janus kinase inhibitors is allowed.
- An ongoing severe active infection or active serious infection requiring anti-infective treatment may prevent enrollment; infectious-disease clearance may be considered.
- Active tuberculosis or untreated latent tuberculosis is exclusionary as specified in the protocol.
- A stroke, heart attack, coronary stent, or coronary bypass surgery within the past six months is exclusionary.
- People who are currently pregnant or breastfeeding cannot participate.
- Receiving a live vaccine within 30 days before the first study dose, or expecting to need one during participation or within 30 days afterward, is exclusionary.
- People meeting the study team's diagnostic criteria for toxic megacolon are excluded.
- A total or subtotal colectomy, ileoanal pouch, Kock pouch, ileostomy, or planned bowel surgery is exclusionary; prior partial colectomy is allowed.
- Active hepatitis B or hepatitis C meeting the registry's laboratory definitions is exclusionary, with stated exceptions for resolved or suppressed hepatitis B.
- Strong CYP3A4 inducers or inhibitors, including grapefruit and grapefruit juice, cannot be used before the first dose or during the study.
Important unknowns
What the record does not make clear
- The registry requires scheduled visits but does not provide their number, timing, length, or whether any can occur remotely.
- The study is randomized and includes placebo groups, but the chance of assignment to placebo is not stated.
- The corticosteroid groups transition to maintenance therapy selected through usual care, but the registry does not identify which therapies may be used or who pays for them.
- The registry says rescue therapy begins if the condition fails to improve or worsens after three days, but it does not identify the rescue treatments or subsequent study participation.
- Eligibility requires ulcerative colitis verified by endoscopy and histology, and baseline tissue findings affect the cytomegalovirus criterion, but the registry does not clarify whether a new study endoscopy or biopsy is required.
- The registry does not state which study drugs, tests, hospital care, usual-care treatments, or other services are billed to participants or insurance.
- The registry does not state whether participants are paid or reimbursed.
- The registry does not state whether transportation, parking, lodging, or other travel support is available.
- The registry identifies a single site in Ann Arbor but does not say whether any visits, surveys, or follow-up can be completed remotely.
- The registry does not state whether upadacitinib remains available through the study after study treatment ends.
- The Ann Arbor site is listed as recruiting, but the registry does not separately report whether both inpatient and outpatient cohorts are currently open.
Before contacting the site
Questions for the study team
- What is the complete schedule and expected length of visits, laboratory testing, and daily symptom surveys through week 52?
- Within my inpatient or outpatient cohort, what is the chance of assignment to upadacitinib placebo?
- What specific rescue therapies are available, and what happens to study participation if rescue therapy is needed?
- Is a new endoscopy or biopsy required during screening, or can prior results establish the diagnosis and cytomegalovirus status?
- Which maintenance treatments may be used after the acute induction phase in the corticosteroid group?
- Which study drugs, tests, hospital services, and usual-care treatments are covered, and which may be billed to me or my insurance?
- Are compensation, parking reimbursement, transportation help, or lodging support available?
- Are both inpatient and outpatient cohorts currently open, and can any follow-up be completed remotely?
Before changing care
Questions for your gastroenterologist
- How would the study's corticosteroid and upadacitinib schedules interact with my current ulcerative colitis medicines?
- Would changing or pausing any current medicine to meet the protocol create concerns given my present disease activity?
- What approved treatment alternatives should I understand before deciding whether to contact the study team?
- How stable or unstable is my ulcerative colitis now, and what symptoms should prompt urgent hospital evaluation rather than waiting for study screening?
- Which risks of upadacitinib and high-dose corticosteroids are most relevant to my infections, cardiovascular history, laboratory results, and other health conditions?
- How would you coordinate monitoring, rescue-treatment decisions, and maintenance therapy with the University of Michigan research team?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This trial is being conducted to learn more about the optimal sequence of various medications in the management of acute severe ulcerative colitis (ASUC). This research is studying multiple drugs already approved by the Food and Drug Administration (FDA). The goal of this study is to test the early efficacy and safety of upadacitinib (Rinvoq) and corticosteroids compared to corticosteroids alone as induction therapy for both inpatients and outpatients with ASUC.
This study will have four phases: eligibility assessment, the acute induction phase (inpatient 0-10 days, outpatient 5 days), post-acute induction phase (end of acute induction phase to day 56 (week 8)), and maintenance phase (week 8-week 48).
Study design and administration
- Organization
- University of Michigan
- Organization class
- Other
- Organization study ID
- HUM00266952
- Lead sponsor
- Berinstein, Jeffrey
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Triple
- Who is masked
- Participant, Care Provider, Investigator
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Upadacitinib plus steroids-Outpatient cohort
This will include patients who meet acute severe ulcerative colitis criteria who are seen in clinic, that contact the clinic, or are sent to the ambulatory, diagnostic and treatment unit (ADTU) without requiring an admission to the hospital. Participants will receive upadacitinib 45mg and hospital dose steroids (IV Methylprednisolone 60mg in an infusion center or ADTU or PO Prednisone 75mg) up to Day 5. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded on Day 5 when the Acute Induction Phase is complete. Upon completion of the Acute Induction Phase, participants will receive upadacitinib 45 mg for 8 weeks concomitant with a 2-week prednisone course. Upadacitinib therapy may continue through week 48, with dosage (45 mg, 30 mg, or 15 mg) titrated based on clinical symptoms and inflammatory biomarkers.
Interventions: Drug: Oral Upadacitinib, Drug: Intravenous Methylprednisolone, Drug: Oral prednisolone Taper, Drug: Oral Prednisone - Hospital Dose Steroids
Active Comparator
Steroids plus Upadacitinib Placebo-Outpatient cohort
This will include patients who meet acute severe ulcerative colitis criteria who are seen in clinic, that contact the clinic, or are sent to the ambulatory, diagnostic and treatment unit (ADTU) without requiring an admission to the hospital. Participants will receive upadacitinib placebo and hospital dose steroids (IV Methylprednisolone 60mg in an infusion center or ADTU or PO Prednisone 75mg) up to Day 5. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded on Day 5 to guide selection of maintenance therapy. Upon completion of the Acute Induction Phase, participants will receive taper prednisone by 5mg per week starting at 40mg with maintenance therapy initiation per usual care.
Interventions: Drug: Intravenous Methylprednisolone, Drug: Oral Upadacitinib Placebo, Drug: Oral prednisolone Taper, Drug: Oral Prednisone - Hospital Dose Steroids
Experimental
Upadacitinib plus steroids- Inpatient cohort
This will include patients seen in the Emergency Department or who are hospitalized. Participants will receive upadacitinib 45mg and hospital dose steroids (IV Methylprednisolone 60mg) until they are discharged. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded as soon as participants are discharged (completion of the Acute Induction Phase). Upon completion of the Acute Induction Phase, participants will receive upadacitinib 45 mg for 8 weeks concomitant with a 2-week prednisone course. Upadacitinib therapy may continue through week 48, with dosage (45 mg, 30 mg, or 15 mg) titrated based on clinical symptoms and inflammatory biomarkers.
Interventions: Drug: Oral Upadacitinib, Drug: Intravenous Methylprednisolone, Drug: Oral prednisolone Taper
Active Comparator
Steroids plus Upadacitinib Placebo- Inpatient cohort
This will include patients seen in the Emergency Department or who are hospitalized. Participants will receive upadacitinib placebo and hospital dose steroids (IV Methylprednisolone 60mg) until they are discharged. If the participant's condition does not improve or if it worsens after 3 days from starting assigned treatment, the participant will be unblinded and put on "rescue therapy". Unrescued participants will be unblinded as soon as participants are discharged (completion of the Acute Induction Phase) to guide maintenance therapy selection (outside of the trial protocol). Upon completion of the Acute Induction Phase, participants will taper prednisone by 5mg per week starting at 40mg with maintenance therapy initiation per usual care.
Interventions: Drug: Intravenous Methylprednisolone, Drug: Oral Upadacitinib Placebo, Drug: Oral prednisolone Taper
Interventions
Drug
Oral Upadacitinib
Doses start at 45milligrams (mg) during acute induction and post-acute induction phase (total of 8 weeks). During the Dose Optimization Maintenance Phase, unrescued participants not undergoing colectomy will continue upadacitinib therapy through week 48, with dosage (45 mg, 30 mg, or 15 mg) titrated based on clinical symptoms and inflammatory biomarkers.
Drug
Intravenous Methylprednisolone
Intravenous (IV) given 60mg daily (in divided or full doses). Inpatients will receive this in the hospital. Outpatient participants can get this at an infusion center. Following completion of the Acute Induction Phase (inpatient cohort: 0-10 days ending at discharge; outpatient cohort: 5 days), participants will be placed on a tapering dose of prednisone.
Drug
Oral Upadacitinib Placebo
The placebo will be discontinued at discharge for the inpatient cohort and after day 5 for the outpatient cohort.
Drug
Oral prednisolone Taper
Following completion of the Acute Induction Phase (inpatient cohort: 0-10 days ending at discharge; outpatient cohort: 5 days), participants will be placed on a tapering dose of prednisone. Participants randomized to the corticosteroid arm will be placed on prednisone at a dose 40mg to be tapered by 5mg/week. Participants randomized to the upadacitinib and corticosteroid arm will be placed on 2 weeks of prednisone (40mg x 2 days, 30mg x 2 days, 25mg x 2 days, 20mg x 2 days, 15mg x 2 days, 10mg x 2 days, and 5mg x 2 days).
Drug
Oral Prednisone - Hospital Dose Steroids
Oral Prednisone 75mg daily can be given for 5 days to participants enrolled in the Outpatient Cohort as an alternative to getting IV methylprednisolone 60mg in an infusion center. Following completion of the Acute Induction Phase, participants will be placed on a tapering dose of prednisone.
Eligibility
18 Years–75 Years
All
Not accepted
Inclusion criteria (12)
- Patient ≥ 18 to 75 years of age at the time of consentRegistry-derived · unreviewed
- Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)Registry-derived · unreviewed
- Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 6 bowel movements per day with visible blood in the 7 days prior to Day 0 plus at least one of the following:Registry-derived · unreviewed
- Temperature \> 37.8 Celsius(C) per patient report or documented in Electronic Health Record (EHR) in the 7 days prior to Day 0.Registry-derived · unreviewed
- ii. Pulse ≥ 90 beats per minute (BPM) per patient report or documented in EHR iin the 7 days prior to Day 0 iii. Hemoglobin ≤ 10.5 grams per deciliter (g/dL) in the 7 days prior to Day 0 iv. Erythrocyte sedimentation rate ≥ 30 millimeters per hour (mm/h) in the 7 days prior to Day 0 v. C-reactive protein ≥ 3.0mg/dL in the 7 days prior to Day 0 vi. Fecal calprotectin \>782 Milligrams per kilogram (mg/kg) in the 7 days prior to consent.Registry-derived · unreviewed
- vii. Oral corticosteroid use for ≥ 7 days in the month prior to consent at a dose equivalent to ≥ 20 milligrams per day (mg/day)Registry-derived · unreviewed
- For a person of reproductive/childbearing potential (i.e., presence of intact ovaries and fallopian tubes and are considered premenopausal by standard assessment), a negative lab-based (serum/urine) pregnancy test is required.Registry-derived · unreviewed
- For a person of reproductive potential (i.e., presence of intact ovaries and fallopian tubes) and has childbearing potential, intent to use at least one effective method of birth control from study Day 0 through the end of blinding or at least 30 days after the last dose of upadacitinib or week 48, whichever occurs most recently. A person without reproductive or childbearing potential does not require an intent to use effective birth control.Registry-derived · unreviewed
- Participants enrolled in the outpatient cohort must be under the care of an outpatient gastroenterologist affiliated with the University of Michigan.Registry-derived · unreviewed
- Ability to take oral medication and be willing to adhere to the study intervention regimen.Registry-derived · unreviewed
- Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily bowel movement symptoms surveys, and other study procedures.Registry-derived · unreviewed
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.Registry-derived · unreviewed
Exclusion criteria (27)
- On IV corticosteroids for \> 72 hours immediately prior to enrollment continuously (at any institution) which is equivalent to a cumulative dose of 180mg of IV Methylprednisolone in the 3 days prior to enrollment.Registry-derived · unreviewed
- Patients with a prior exposure upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (e.g., tofacitinib, baricitinib, or filgotinib) are permissible.Registry-derived · unreviewed
- History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline. (Note: A Urine Drug Screen does not need to be performed).Registry-derived · unreviewed
- A history of two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster.Registry-derived · unreviewed
- Patients with ongoing severe active infection (as determined by the study team) per investigator. Patients with active serious infection(s) requiring treatment with intravenous anti-infectives or oral/intramuscular anti-infectives may consider infectious disease clearance.Registry-derived · unreviewed
- Active tuberculosis (TB) or untreated latent TB as described in the protocol.Registry-derived · unreviewed
- In participants that tested positive for Coronavirus disease 2019 (COVID-19), at least 5 days must have passed between a COVID-19 positive test result and the baseline visit of asymptomatic participants. Participants with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if deemed appropriate by the investigator based upon the participant's health status.Registry-derived · unreviewed
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery.Registry-derived · unreviewed
- Known hypersensitivity to the following drugs or constituents (and its excipients): methylprednisolone, prednisone, upadacitinib, or upadacitinib placebo. The following ingredients can be found in upadacitinib and upadacitinib placebo: colloidal silicon dioxide, hypromellose, iron oxide yellow and iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. This includes a known or suspected hypersensitivity to cow's milk for patients expected to be in the inpatient cohort (component of methylprednisolone).Registry-derived · unreviewed
- Participants that are currently pregnant or breastfeeding. Participants with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result. Participants with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.Registry-derived · unreviewed
- Participants that have received any live vaccine with replicating potential within 30 days prior to the first dose of study drug or are expected to need a live vaccination with any replicating potential during study participation or within 30 days of study completion.Registry-derived · unreviewed
- Patients that meet diagnostic criteria for toxic megacolon as determined by the study and treatment team. Patients are expected to have dilation of the transverse colon \> 6 centimeters (cm) or cecum/right colon \> 9cm and three of the following signs of systemic toxicity (Temperature \> 38◦C, Heart rate (HR) \> 120 beats per minute (BPM), white blood cells (WBC) \> 10500/microliter (µL), Hemoglobin \< 10.5mg/dL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, or hypotension)Registry-derived · unreviewed
- Patients with active Cytomegalovirus (CMV) colitis as defined as having \> 5 CMV inclusion bodies per high powered field in any one ulcer at baseline. If CMV colitis is confirmed, the patient can remain in the trial if permissible by the infectious disease and primary treatment team and if concomitant anti-viral therapy is initiated.Registry-derived · unreviewed
- Patients that had received any investigational agent or procedure within 30 days or five half-lives prior to baseline, whichever is longer, or were enrolled in an interventional study.Registry-derived · unreviewed
- Patients with an active malignancy with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.Registry-derived · unreviewed
- Patients that had a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or were planning bowel surgery (partial colectomy is permissible)Registry-derived · unreviewed
- Patients with certain laboratory abnormalities suggestive of moderate or severe renal, hematological, or gastrointestinal/liver impairment (per protocol).Registry-derived · unreviewed
- History of or clinical evidence of liver cirrhosisRegistry-derived · unreviewed
- History of inherited or acquired conditions that predispose to hypercoagulability (per protocol). Please note, that patients with a remote history of provoked thromboembolic event or recent thromboembolic event on systemic anticoagulation are NOT exclusionary.Registry-derived · unreviewed
- Active Hepatitis B Infection: Hepatitis B surface antigen (HBsAg) positive with detectable deoxyribonucleic acid (DNA) not on therapy. Patients with serologic evidence of a resolved prior hepatitis B virus (HBV) infection (i.e., HBsAg-negative and anti-HB Core-positive) or patients with HBsAg positive on suppressive HBV therapy with low DNA (\<105 copies/milliliter (mL) or \<104 IU/mL negative) are not exclusionary.Registry-derived · unreviewed
- Active Hepatitis C Infection: Hepatitis C Virus (HCV) ribonucleic acid detectable in any patient with anti-HCV antibody.Registry-derived · unreviewed
- Acquired Immunodeficiency Syndrome: Confirmed positive anti-human immunodeficiency virus (HIV) antibody with cluster of differentiation 4 (CD4) counts \<350 cells/microliter (uL) or Acquired Immune Deficiency Syndrome (AIDS)- defining opportunist infection.Registry-derived · unreviewed
- Solid organ or bone marrow transplant within 1 year or expected transplant within 6 months of randomization.Registry-derived · unreviewed
- Patients that had a history of spontaneous GI perforation (other than appendicitis or mechanical injury) or are at significantly increased risk of GI perforation per investigator's judgment.Registry-derived · unreviewed
- Actively receiving strong CYP3A4 inducers or inhibitors prior to the first dose of study drug or are expected to receive any of these medications during the study period. This includes grapefruit and grapefruit juice.Registry-derived · unreviewed
- The presence of any condition possibly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery) as determined by the investigator. Procedures such as gastric banding that simply divide the stomach into separate chambers are not exclusionary.Registry-derived · unreviewed
- Patients that had a history of a clinically significant medical condition per protocol.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
The proportion of participants with an initial clinical response without rescue therapy or colectomy by treatment Day 5 after initiating induction therapy in the upadacitinib and corticosteroid arm compared to the corticosteroid monotherapy arm
Time frame: Treatment 5 days
Initial Clinical Response Definition: * A reduction in liquid bowel movements per 24 hours by ≥ 60% from randomization AND a C-reactive protein (CRP) \< 1.5 milligrams per deciliter (mg/dL) AND no more than trace blood in stool, or * 4 liquid bowel movements or less per 24 hours AND a C-reactive protein (CRP) \< 1.5 mg/dL AND no more than trace blood in stool. Liquid bowel movements are defined as completely liquid (Bristol stool chart type 7) or mostly liquid (Bristol stool chart type 8). If the patient is discharged prior to outcome assessment on treatment Day 5, the most recent CRP prior to treatment Day 5 will be to evaluate primary outcome (carry forward manner). If a patient has not experienced CRP improvement to \<1.5mg/dL prior to discharge, patient will be requested to obtain a treatment Day 5 CRP as an outpatient lab on treatment Day 5.
Secondary outcome
The proportion of participants in the outpatient cohort with a hospital admission by end of the acute induction phase (Day 5) in the upadacitinib and corticosteroid arm compared to the corticosteroid monotherapy arm.
Time frame: Day 5
Secondary outcome
The proportion of participants undergoing colectomy without rescue therapy by the end of the post-acute induction phase (week 8/day 56) in the upadacitinib and corticosteroid arm compared to the corticosteroid monotherapy arm
Time frame: Week 8 (day 56)
Secondary outcome
The proportion of participants undergoing colectomy without rescue therapy by week 12/Day 84 in the upadacitinib and corticosteroid arm compared to the corticosteroid monotherapy arm
Time frame: Week 12 (Day 84)
Secondary outcome
The proportion of participants undergoing colectomy without rescue therapy by Week 48/Day 336 in the upadacitinib and corticosteroid arm compared to the corticosteroid monotherapy arm
Time frame: Week 48 (Day 336)
Secondary outcome
The proportion of participants in clinical response without colectomy or rescue therapy by end of post-acute induction phase (week 8/day 56) in the upadacitinib and corticosteroid arm compared corticosteroid monotherapy arm
Time frame: Week 8 (day 56)
Clinical response is defined by having a C-reactive protein (CRP) \<0.8 mg/dL AND ≤ 4 liquid bowel movements per 24 hours and no more than trace blood in stool.
Secondary outcome
The proportion of participants in clinical response without colectomy or rescue therapy by week 12/Day 84 in the upadacitinib and corticosteroid arm compared corticosteroid monotherapy arm
Time frame: Week 12 (Day 84)
Clinical response is defined by having a C-reactive protein (CRP) \<0.8 mg/dL AND ≤ 4 liquid bowel movements per 24 hours and no more than trace blood in stool.
Secondary outcome
The proportion of participants in clinical response without colectomy or rescue therapy by week 48/Day 336 in the upadacitinib and corticosteroid arm compared corticosteroid monotherapy arm
Time frame: Week 48 (Day 336)
Clinical response is defined by having a C-reactive protein (CRP) \<0.8 mg/dL AND ≤ 4 liquid bowel movements per 24 hours and no more than trace blood in stool.
Secondary outcome
The proportion of participants in corticosteroid-free clinical remission without colectomy or rescue therapy by week 8/Day 56 in the upadacitinib and corticosteroid compared to corticosteroid monotherapy arm
Time frame: Week 8 (Day 56)
Clinical remission is defined as having ≤ 2 liquid bowel movements per 24 hours and having visible rectal bleeding score of 0. Corticosteroid-free clinical remission is defined as being in clinical remission without the use of corticosteroids ≥ 14 days prior to time-point
Secondary outcome
The proportion of participants in corticosteroid-free clinical remission without colectomy or rescue therapy by week 12/Day 84 in the upadacitinib and corticosteroid compared to corticosteroid monotherapy arm
Time frame: Week 12 (Day 84)
Clinical remission is defined as having ≤ 2 liquid bowel movements per 24 hours and having visible rectal bleeding score of 0. Corticosteroid-free clinical remission is defined as being in clinical remission without the use of corticosteroids ≥ 14 days prior to time-point
Secondary outcome
The proportion of participants in corticosteroid-free clinical remission without colectomy or rescue therapy by week 48/Day 336 in the upadacitinib and corticosteroid compared to corticosteroid monotherapy arm
Time frame: Week 48 (Day 336)
Clinical remission is defined as having ≤ 2 liquid bowel movements per 24 hours and having visible rectal bleeding score of 0. Corticosteroid-free clinical remission is defined as being in clinical remission without the use of corticosteroids ≥ 14 days prior to time-point
Secondary outcome
Incidence and severity of adverse events by end of the Acute Induction Phase (Inpatient Cohort: 0-10 days; Outpatient Cohort: 5 days)
Time frame: End of the acute induction phase (0-10 days) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence and severity of adverse events by the end of the post-acute induction phase (week 8/Day 56)
Time frame: Post-acute induction phase (week 8/Day 56) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence and severity of adverse events by week 12/Day 84
Time frame: Week 12 (Day 84) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence and severity of adverse events by week 52/Day 365 (Study period + 4-week safety follow-up period) in the safety population
Time frame: Week 52 (Day 365) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence of serious infections by end of the acute induction phase (0-10 days)
Time frame: Acute induction phase (0-10 days) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence of serious infections by post-acute induction phase week 8/Day 56
Time frame: Week 8 (Day 56) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence of serious infections by end of week 12/Day 84
Time frame: Week 12 (Day 84) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence of serious infections by Week 52/Day 365 (Study Period + 4-week Safety Follow-up)
Time frame: Week 52 (Day 365) in the safety population
Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence and severity of adverse events of special interest (AESI) by end of the acute induction phase (0-10 days)
Time frame: Acute induction phase (0-10 days) in the safety population
Adverse events of special interest include serious infections, opportunistic infections, herpes zoster, active TB, malignancy (all types), adjudicated gastrointestinal perforations, adjudicated cardiovascular events (e.g., major adverse cardiac event (MACE)), anemia, neutropenia, lymphopenia, renal dysfunction, hepatic disorder, adjudicated embolic and thrombotic events (non-cardiac, non-central nervous system), serious hypersensitivity reactions, bone fracture, and retinal detachment. Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence and severity of adverse events of special interest by week 8/Day 56
Time frame: Week 8 (Day 56) in the safety population
Adverse events of special interest include serious infections, opportunistic infections, herpes zoster, active TB, malignancy (all types), adjudicated gastrointestinal perforations, adjudicated cardiovascular events (e.g., major adverse cardiac event (MACE)), anemia, neutropenia, lymphopenia, renal dysfunction, hepatic disorder, adjudicated embolic and thrombotic events (non-cardiac, non-central nervous system), serious hypersensitivity reactions, bone fracture, and retinal detachment. Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence and severity of adverse events of special interest by week 12/Day 84
Time frame: Week 12 (Day 84) in the safety population.
Adverse events of special interest include serious infections, opportunistic infections, herpes zoster, active TB, malignancy (all types), adjudicated gastrointestinal perforations, adjudicated cardiovascular events (e.g., major adverse cardiac event (MACE)), anemia, neutropenia, lymphopenia, renal dysfunction, hepatic disorder, adjudicated embolic and thrombotic events (non-cardiac, non-central nervous system), serious hypersensitivity reactions, bone fracture, and retinal detachment. Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Secondary outcome
Incidence and severity of adverse events of special interest for by week 52/Day 365 (Study period + 4-week Safety Follow-up Period) in the safety population
Time frame: Week 52 (Day 365) in the safety population.
Adverse events of special interest include serious infections, opportunistic infections, herpes zoster, active TB, malignancy (all types), adjudicated gastrointestinal perforations, adjudicated cardiovascular events (e.g., major adverse cardiac event (MACE)), anemia, neutropenia, lymphopenia, renal dysfunction, hepatic disorder, adjudicated embolic and thrombotic events (non-cardiac, non-central nervous system), serious hypersensitivity reactions, bone fracture, and retinal detachment. Adverse events will be graded to the 5 criteria as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5. Safety population includes all participants that received at least one dose of study drug
Recruiting locations in the United States
University of Michigan
RecruitingAnn Arbor, Michigan, 48109, United States
Syed Hassan734-232-5134hasyed@umich.edu
Jeffrey Berinstein, MD, MSc
Central study contacts
Registry dates
- First posted
- Dec 2, 2025
- Primary completion
- Dec 2029
- Overall completion
- Dec 2030
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.