Upadacitinib versus Oral Corticosteroid for Induction of Transmural Remission in Moderate to Severe Ulcerative Colitis and Crohn’s Disease Flares - INDUCE
Mater Misericordiae Ltd
80 participants
Oct 2, 2025
Interventional
Conditions
Summary
INDUCE is a multicentre prospective randomised controlled trial to compare the efficacy and safety (using standardised clinical outcomes plus non-invasive monitoring of mucosal healing using gastrointestinal ultrasound of Upadacitinib vs Corticosteroid in patients with Ulcerative Colitis and Crohn's Disease flares. We hypothesize that upadacitinib is non-inferior in terms of efficacy to prednisolone for disease flares, with no difference in rate of adverse event.
Eligibility
Inclusion Criteria6
- Aged between 18-65
- Have ability to give informed consent
- Moderately active disease flares evidenced by PRO-2 score of greater than or equal to 4
- Have confirmed objective evidence of UC or CD flares by C-reactive protein (CRP), Intestinal Ultrasound (IUS), Faecal Calprotectin (FCP) or Endoscopy
- Suitable to be prescribed a weaning course of oral corticosteroid for induction of remission
- Completed pre-screening tests (blood test and chest x-ray) for upadacitinib therapy, including hepatitis B, hepatitis C, human immunodeficiency virus, varicella zoster virus, tuberculosis, mumps, measles and rubella
Exclusion Criteria11
- Evidence of ASUC (by truelove and witts criteria)
- Pregnant or breastfeeding
- Evidence of gastrointestinal infection on clinical evaluation
- History of solid organ or haematological malignancy within 2 years, significant cardiorespiratory disease, thrombophilia or thromboembolic disorder
- Any absolute contraindication to corticosteroids
- Be part of any other interventional trial
- Current or prior upadacitinib use
- Greater than 7 days of oral corticosteroid prior to screening or greater than 24 hours of IV corticosteroid
- Chronic liver disease (Child Pugh B or C), chronic hepatitis B
- Active infections, including hepatitis B or C, human immunodeficiency virus, varicella zoster virus, tuberculosis, mumps, measles and rubella
- History of hypersensitivity or adverse events to other JAK inhibitor
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Interventions
Participants in this study will be adults attending hospital for inpatient or outpatient care with moderate to severely active Ulcerative Colitis or Crohn's Disease flares. Follow up with clinical, biochemical and intestinal ultrasound will occur at week 0, 2 and 6 with safety follow-up at week 12. The interventional arm (randomised) will be upadacitinib for a 6 week period for flare management. Upadacitinib will be dosed at 45mg oral tablet once daily.
Locations(1)
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ACTRN12625000861459