Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000861459p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2025
Date registered
8/08/2025
Date last updated
8/08/2025
Date data sharing statement initially provided
8/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Upadacitinib versus Oral Corticosteroid for Induction of Transmural Remission in Moderate to Severe Ulcerative Colitis and Crohn’s Disease Flares - INDUCE
Scientific title
Upadacitinib versus Oral Corticosteroid for Induction of Transmural Remission in Moderate to Severe Ulcerative Colitis and Crohn’s Disease Flares - INDUCE
Secondary ID [1] 314705 0
Nil known
Universal Trial Number (UTN)
Trial acronym
INDUCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 337892 0
Ulcerative Colitis 338002 0
Crohn's Disease 338003 0
Condition category
Condition code
Oral and Gastrointestinal 334223 334223 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 334317 334317 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 331312 0
Treatment: Drugs
Comparator / control treatment
The control arm (randomised) will be prednisolone (oral tablet) 50mg standardised wean over 6 weeks
-2 weeks of 50mg daily
-1 week of 37.5mg daily
-1 week of 25mg daily
-1 week of 12.5mg daily
-1 week of 5mg daily
Control group
Active

Outcomes
Primary outcome [1] 341883 0
1. Proportion of participants with Ulcerative Colitis who meet criteria for clinical remission at week 6 post-randomisation
Timepoint [1] 341883 0
The primary outcome of clinical remission will be assessed at week 6 post randomisation.
Primary outcome [2] 342145 0
2. Proportion of participants with Crohn's Disease who meet criteria for clinical remission at week 6 post-randomisation
Timepoint [2] 342145 0
The primary outcome of clinical remission will be assessed at week 6 post-randomisation.
Secondary outcome [1] 448882 0
1. Proportion of participants with Ulcerative Colitis or Crohn's Disease who meet criteria for Clinical remission at week 2 post-randomisation
Timepoint [1] 448882 0
Week 2 post-randomisation
Secondary outcome [2] 449202 0
2. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Clinical Response at week 2 post-randomisation
Timepoint [2] 449202 0
Week 2 post-randomisation
Secondary outcome [3] 449203 0
3. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Clinical Response at week 6 post-randomisation
Timepoint [3] 449203 0
Week 6 post-randomisation
Secondary outcome [4] 449204 0
4. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Biochemical Remission at week 2 post-randomisation
Timepoint [4] 449204 0
Week 2 post-randomisation
Secondary outcome [5] 449205 0
5. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Biochemical Remission at week 6 post-randomisation
Timepoint [5] 449205 0
Week 6 post-randomisation
Secondary outcome [6] 449206 0
6. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Biochemical Remission at week 6 post-randomisation
Timepoint [6] 449206 0
Week 6 post randomisation
Secondary outcome [7] 449207 0
7. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Transmural response by Intestinal Ultrasound (IUS) at week 2 post-randomisation
Timepoint [7] 449207 0
Week 2 post randomisation
Secondary outcome [8] 449208 0
8. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Transmural response by IUS at week 6 post-randomisation
Timepoint [8] 449208 0
Week 6 post-randomisation
Secondary outcome [9] 449209 0
9. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Transmural remission by IUS at week 2 post-randomisation
Timepoint [9] 449209 0
Week 2 post-randomisation
Secondary outcome [10] 449210 0
10. Proportion of patients with Ulcerative Colitis or Crohn's Disease who meet criteria for Transmural remission by IUS at week 6 post-randomisation
Timepoint [10] 449210 0
Week 6 post-randomisation
Secondary outcome [11] 449211 0
11. Rate of adverse events
Timepoint [11] 449211 0
Week 12 post-randomisation
Secondary outcome [12] 449212 0
12. Change in quality of life using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) tool at week 2 post-randomisation
Timepoint [12] 449212 0
Week 2 post-randomisation
Secondary outcome [13] 449213 0
13. Change in quality of life using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) tool at week 6 post-randomisation
Timepoint [13] 449213 0
Week 6 post-randomisation
Secondary outcome [14] 449214 0
14. Change in quality of life using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) tool at week 12 post-randomisation
Timepoint [14] 449214 0
Week 12 post-randomisation
Secondary outcome [15] 449215 0
15. Change in quality of life using Depression, Anxiety and Stress Scale (DASS) tool at week 2 post-randomisation
Timepoint [15] 449215 0
Week 2 post-randomisation
Secondary outcome [16] 449735 0
16. Change in quality of life using Depression, Anxiety and Stress Scale (DASS) tool at week 6 post-randomisation
Timepoint [16] 449735 0
Week 6 post-randomisation
Secondary outcome [17] 449736 0
17. Change in quality of life using Depression, Anxiety and Stress Scale (DASS) tool at week 12 post-randomisation
Timepoint [17] 449736 0
Week 12 post-randomisation
Secondary outcome [18] 449737 0
18. Change in quality of life using Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) tool at week 2 post-randomisation
Timepoint [18] 449737 0
Week 2 post-randomisation
Secondary outcome [19] 449738 0
19. Change in quality of life using Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) tool at week 6 post-randomisation
Timepoint [19] 449738 0
Week 6 post-randomisation
Secondary outcome [20] 449739 0
18. Change in quality of life using Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) tool at week 12 post-randomisation
Timepoint [20] 449739 0
Week 12 post-randomisation
Secondary outcome [21] 449740 0
21. Feasibility of expanding this study to a larger multi-centre trial
Timepoint [21] 449740 0
Week 12 post-randomisation

Eligibility
Key inclusion criteria
Inclusion criteria
1. Aged between 18-65
2. Have ability to give informed consent
3. Moderately active disease flares evidenced by PRO-2 score of greater than or equal to 4
4. Have confirmed objective evidence of UC or CD flares by C-reactive protein (CRP), Intestinal Ultrasound (IUS), Faecal Calprotectin (FCP) or Endoscopy
5. Suitable to be prescribed a weaning course of oral corticosteroid for induction of remission
6. 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Evidence of ASUC (by truelove and witts criteria)
2. Pregnant or breastfeeding
3. Evidence of gastrointestinal infection on clinical evaluation
4. History of solid organ or haematological malignancy within 2 years, significant cardiorespiratory disease, thrombophilia or thromboembolic disorder
5. Any absolute contraindication to corticosteroids
6. Be part of any other interventional trial
7. Current or prior upadacitinib use
8. Greater than 7 days of oral corticosteroid prior to screening or greater than 24 hours of IV corticosteroid
9. Chronic liver disease (Child Pugh B or C), chronic hepatitis B
10. Active infections, including hepatitis B or C, human immunodeficiency virus, varicella zoster virus, tuberculosis, mumps, measles and rubella
11. History of hypersensitivity or adverse events to other JAK inhibitor

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by REDCap software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation software (REDCap)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/10/2025
Actual
Date of last participant enrolment
Anticipated
2/10/2028
Actual
Date of last data collection
Anticipated
2/01/2029
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319254 0
Hospital
Name [1] 319254 0
Mater Misericordiae Ltd
Country [1] 319254 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Ltd
Address
Country
Australia
Secondary sponsor category [1] 321728 0
None
Name [1] 321728 0
None
Address [1] 321728 0
Country [1] 321728 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317835 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 317835 0
Ethics committee country [1] 317835 0
Australia
Date submitted for ethics approval [1] 317835 0
24/06/2025
Approval date [1] 317835 0
Ethics approval number [1] 317835 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 142306 0
A/Prof Jakob Begun
Address 142306 0
Mater Hospital Brisbane, Raymond Terrace, South Brisbane, QLD 4101
Country 142306 0
Australia
Phone 142306 0
+61 423128933
Fax 142306 0
Email 142306 0
[email protected]
Contact person for public queries
Name 142307 0
Dr Robert Gilmore
Address 142307 0
Mater Hospital Brisbane, Raymond Terrace, South Brisbane, QLD 4101
Country 142307 0
Australia
Phone 142307 0
+61 07 3163 8196
Fax 142307 0
Email 142307 0
[email protected]
Contact person for scientific queries
Name 142308 0
Dr Robert Gilmore
Address 142308 0
Mater Hospital Brisbane, Raymond Terrace, South Brisbane, QLD 4101
Country 142308 0
Australia
Phone 142308 0
+61 07 3163 8196
Fax 142308 0
Email 142308 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.