A comparative study on how well upadacitinib performs compared to oral prednisolone in treating and sustaining remission in moderate to severe ulcerative colitis
| ISRCTN | ISRCTN15078551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15078551 |
| Secondary identifying numbers | 5262 |
- Submission date
- 02/03/2024
- Registration date
- 13/03/2024
- Last edited
- 24/07/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
The purpose of this study is to investigate and compare the effectiveness and safety of two different treatment options (Upadacitinib vs Prednisolone) which are currently available for the induction and maintenance of remission in patients with moderate-to-severe ulcerative colitis (UC).
Who can participate?
The sample population will include all patients between the ages of 18 – 60 years with moderate-to-severe UC.
What does the study involve?
The study consists of two phases: an induction trial lasting 8 weeks, followed by a maintenance trial lasting 40 weeks, totaling 48 weeks.
During the induction trial, participants will either receive Upadacitinib at a daily dose of 45mg or oral Prednisolone at a daily dose of 40mg, which will then be tapered by 5mg each week. If a good response is observed by week 8, participants will continue or switch to Upadacitinib for the maintenance trial, lasting an additional 40 weeks. The maintenance dose depends on prior exposure to biologic therapy: biologic-naïve participants will receive Upadacitinib 15mg daily, while those previously exposed to biologic therapy will receive Upadacitinib 30mg daily.
Participants not showing a clinical response by week 8 will be withdrawn from the study and offered alternative treatment options. Although treatments are randomly assigned, both participants and researchers will be aware of the assigned treatment, and participants will receive an information sheet detailing their treatment.
Before treatment, participants will undergo blood tests for Hepatitis B, Hepatitis C, TB, and HIV. Positive results will lead to withdrawal from the study. Eligible participants will undergo baseline colonoscopy and repeat colonoscopy at weeks 8 and 48. Stool and blood samples will be collected at weeks 0, 8, and 48 for testing. Participants will keep a symptom diary and complete questionnaires to assess the impact of ulcerative colitis on their quality of life.
During the induction trial, participants will attend the IBD clinic at weeks 2, 4, and 8. If eligible for the maintenance trial, clinic visits will occur every 8 weeks until week 48, allowing for reporting of adverse events and monitoring of drug levels.
What are the possible benefits and risks of participating?
The main benefit will be that derived directly from receiving one of the treatment options offered by the study. The treatment is expected to lead to an overall improvement in your symptoms and thus, overall improvement in your health-related quality of life.
Furthermore, other indirect benefits will involve those derived from utilizing the results of this study to contribute to the scientific knowledge that is known about the efficacy and safety of the treatment options that are currently available for ulcerative colitis.
The physical risks may include those related to the side effects of your allocated treatment. More specific details about each treatment will be provided to you once the random assignment of treatment is complete. Other risks may include the risks of undergoing a colonoscopy which include the risk of bleeding, infection, perforation, abdominal pain, and reaction to the sedative given during the procedure. Moreover, you may experience some mild discomfort when getting your blood drawn for the laboratory tests mentioned above. You may develop some bruising and minor tenderness around the site of needle insertion.
Where is the study run from?
Ministry of Health Kuwait
When is the study starting and how long is it expected to run for?
February 2024 to June 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mohammad Shehab, dr_mshehab@hotmail.com
Contact information
Scientific, Principal Investigator
Haya Al-Habeeb Gastroenterology Center, Mubarak AlKabeer Hospital, Jabriya, Block 4, Street 109.
Kuwait City
046304
Kuwait
 ORCID ID |
0000-0003-2084-3956 |
|---|---|
| Phone | +96599633181 |
| moshehab@moh.gov.kw |
Public
Mubarak AlKabeer Hospital, Department of Internal Medicine
Kuwait City
046306
Kuwait
| ORCID ID |
0009-0007-9749-0796 |
|---|---|
| Phone | +965 99692090 |
| raghadalyousefi@gmail.com |
Scientific
Kuwait University, Health Sciences Center, College of Pharmacy, Office 146
Kuwait City
-
Kuwait
| ORCID ID |
0000-0003-4020-5978 |
|---|---|
| Phone | +965 99006134 |
| Fatema.alrashed@ku.edu.kw |
Study information
| Study design | Prospective multicenter open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety, Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Comparative efficacy and safety of upadacitinib versus oral prednisolone for the induction and maintenance of remission in moderate to severe ulcerative colitis: a prospective, multicenter, open-label, randomised controlled trial (PREDUPA Trial) |
| Study acronym | PREDUPA |
| Study objectives | Upadacitinib is more efficacious and safe than oral prednisolone at inducing and maintaining remission in moderate-to-severe ulcerative colitis. |
| Ethics approval(s) |
Approved 22/07/2024, Permanent Committee for Coordination and Health Research - Ministry of Health Kuwait (Sulaibkhat - Jamal Abdel Nasser Street, Kuwait City, PO Box 5, Zip code 13001, Kuwait; +965 1810005; appsupport@moh.gov.kw), ref: 1217 |
| Health condition(s) or problem(s) studied | Moderate-to-severe ulcerative colitis |
| Intervention | This study will be a prospective, multicenter, open-label, randomised controlled trial in Kuwait. It is comprised of an 8-week induction trial followed by a 40-week maintenance trial with a treat-through design. The sample population will include all patients between the ages of 18 – 60 with moderate-to-severe UC. To be enrolled, patients must have a Modified Mayo Score (MMS; range 0 – 9, with higher scores being indicative of greater severity of UC) between 4 – 9 with an endoscopic subscore of 2 – 3 at baseline (week 0). The endoscopic subscores will be based on images or videos taken during colonoscopies done by consultant gastroenterologists or endoscopists at multiple centres across Kuwait. The endoscopic Mayo scores will be validated by a single IBD specialist who will then be blinded to treatment allocation, clinical response and endoscopy time point throughout the whole 48-week study period. Eligible patients will then be randomly assigned in a 1:1 ratio to receive either Upadacitinib (45mg daily) or oral Prednisolone (40mg daily, tapered by 5mg every week) for a total duration of 8 weeks. Participants who achieve clinical response at week 8 will proceed into the maintenance trial whereby all responders will either continue or commence treatment with Upadacitinib at a maintenance dose for 40 additional weeks (15mg once daily and 30mg once daily for biologic-naïve and biologic-experienced patients, respectively). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Upadacitinib, prednisolone |
| Primary outcome measure | Primary outcomes for the induction trial (week 1 – 8): 1. Clinical response or clinical remission at week 8: 1.1. Clinical response – defined as a decrease in the MMS by ≥2 points with an overall decrease of ≥30% from baseline, in addition to either a rectal bleeding (RB) subscore of 0 or 1 or a decrease in RB subscore by ≥1 point from baseline. 1.2. Clinical remission – defined as a modified Mayo stool-frequency (SF) subscore of 0 or a SF subscore of 1 with a decrease of ≥1 point from baseline, in addition to a RB subscore of 0 and an endoscopic subscore (ES) of 0 or 1. Primary outcomes for the maintenance trial (week 9 – 48): 2. Clinical remission at week 40 (i.e. at 48 weeks overall) 2.1. Clinical remission – defined as a modified Mayo stool-frequency (SF) subscore of 0 or a SF subscore of 1 with a decrease of ≥1 point from baseline, in addition to a RB subscore of 0 and an endoscopic subscore (ES) of 0 or 1. |
| Secondary outcome measures | 1. Inflammatory bowel disease questionnaire (IBD-Q) score to assess health-related quality of life: This will be assessed at baseline (week 0) then repeated at week 8 and 48 of the study. 2. C-Reactive Protein (CRP) (<10): A blood sample will be taken to monitor the CRP level at baseline (week 0), week 8 and 48 of the study. 3. Fecal calprotectin (<200): A fecal sample will be collected to monitor the fecal calprotectin level at baseline (week 0), week 8 and 48 of the study. |
| Overall study start date | 01/02/2024 |
| Completion date | 01/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Males + Females with moderate-to-severe UC 2. Age 18 – 60 years 3. All durations of disease 4. All extents of disease (proctitis / left-sided colitis / pancolitis) 5. Previously failed to respond to conventional therapies and/or anti-TNF therapy 6. Biologic-naïve 7. On a stable dose of 5-ASA or immunomodulator four weeks prior to the start of the study |
| Key exclusion criteria | 1. Pregnant / lactating 2. Crohn’s colitis 3. Latent or active TB 4. Active infection 5. Current or past malignancy 6. Active or past thromboembolic disease |
| Date of first enrolment | 01/09/2024 |
| Date of final enrolment | 01/09/2025 |
Locations
Countries of recruitment
- Kuwait
Study participating centres
Kuwait City
046304
Kuwait
Kuwait City
PO Box 13373 Farwaniya 81004
Kuwait
Kuwait City
PO Box 240 Safat, Code 13003
Kuwait
Sponsor information
Government
Sulaibkhat - Jamal Abdel Nasser Street.
Kuwait City
13001
Kuwait
| Phone | +9651810005 |
|---|---|
| appsupport@moh.gov.kw | |
| Website | http://www.moh.gov.kw/en |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 25/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be published as a supplement to the results publication. |
Editorial Notes
24/07/2025: The completion date was changed from 01/12/2025 to 01/06/2026.
03/04/2025: The overall end date was changed from 01/04/2025 to 01/12/2025.
19/03/2025: Contact details updated.
06/08/2024: Ethics approval was added.
26/06/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/07/2024 to 01/09/2024.
2. The recruitment end date was changed from 01/04/2025 to 01/09/2025.
04/04/2024: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2024 to 01/07/2024.
2. The recruitment end date was changed from 01/05/2024 to 01/04/2025.
3. The overall end date was changed from 03/03/2025 to 01/04/2025.
4. The plain English summary was updated to reflect these changes.
13/03/2024: Trial's existence confirmed by Mubarak Al-Kabeer Hospital.
