A Phase 4 interventional study of Upadacitinib and Corticosteroid in Acute Severe Ulcerative Colitis, sponsored by Yongquan Shi. Recruiting at 4 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Yongquan Shi · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to learn comparative effectiveness and safety of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis. The main questions it aims to answer are:
Researchers will compare upadacitinib with corticosteroids to evaluate the efficacy of upadacitinib in the treatment of acute severe ulcerative colitis.Participants will:
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 46 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Yongquan Shi is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily.
Drug: Upadacitinib
Methylprednisolone for injection 60 mg/day. If clinical response is achieved, switch to oral prednisone acetate tablets after 5 days (calculated at 0.75 mg/kg/day), followed by a weekly prednisone taper of 5 mg. When the dose is reduced to 20 mg, taper by 2.5 mg weekly until discontinued, with mesalazine 4 g/day as maintenance therapy.
Drug: Corticosteroid
Safety and efficacy of the drug
Safety and efficacy of the drug
Primary Outcome Measure
clinical response by day 7 (defined as a reduction in Lichtiger score to \<10 points with a decrease of ≥3 points from baseline improvement in rectal bleeding, and decreased stool frequency to ≤4 per day).
Time frame: The primary outcome was assessed by the investigator between days 3 and 7, with patients recorded as clinical responders if they had the primary outcome on any day in this assessment window.
clinical response by day 14
Defined as mayo score decrease of ≥30% and ≥3 points from baseline, accompanied by a decrease in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1.
Time frame: day 14
clinical remission by day 28, day 42, and day 90
Total Mayo score ≤2 points and no individual subscore \>1 point.
Time frame: day 28, day 42, and day 90
Endoscopic response by day 90
A decrease in MES score of ≥1 point, or a decrease of ≥50% from baseline.
Time frame: day 90
Endoscopic remission by day 90
MES score ≤1
Time frame: day 90
Endoscopic+clinical response
Partial Mayo score ≤1 and MES ≤1
Time frame: day 90
Clinical +FcP remission
Partial Mayo score ≤1 and FcP≤250mg/kg
Time frame: day 90
Clinical +CRP remission
Partial Mayo score ≤1 and CRP≤5mg/L
Time frame: day 90
Histologic remission
typically defined as the absence of signs of neutrophilic infiltration. The specific criterion is a score below 2B.0, i.e., no increased neutrophils in the lamina propria.
Time frame: day 90
Histologic improvement
when assessing treatment efficacy, a score ≤ 3.1 (intraepithelial neutrophilic infiltration involving \< 50% of crypts) is used as the threshold for histologic improvement.
Time frame: day 90
Adverse Reactions
Adverse Reactions
Time frame: day 90
IBDQ and fatigue questionnaire scores
IBDQ and fatigue questionnaire scores
Time frame: day 0 and day 90
Plan to share: No
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.
Of 48 non-industry phase 4 interventional studies under Colitis, Ulcerative, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 66. This study's planned 12 months is below that.
Counting every sponsor, half of 63 studies reached it within 43 months; a quarter within 25 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Upadacitinib
Yongquan Shi