A comparative study on how well upadacitinib performs compared to oral prednisolone in treating and sustaining remission in moderate to severe ulcerative colitis

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)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15078551

Enrollment

126

Registered

2024-03-13

Start date

2024-09-01

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe ulcerative colitis Digestive System

Interventions

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-thro

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

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Kuwait

Contacts

Public ContactRaghad AlYousefi

raghadalyousefi@gmail.com+965 99692090

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026