Acute Severe Ulcerative ColitisPhase 4NCT07550673
Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）
A Phase 4 study testing upadacitinib and Infliximab in people with Acute Severe Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases at 4 sites in China.
Trial summary
This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Severe Ulcerative Colitis
- What is being tested?
- upadacitinib and Infliximab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 4 sitesChina
- Study dates
- 20 Apr 2026to 1 Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with ASUC
- Aged 18 years or older.
- No gender restriction.
Who cannot join
- Presence of contraindications, allergy, or intolerance to upadacitinib or infliximab.
- Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.
- Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.
- Pregnant or breastfeeding women.
- Unwilling to participate in the clinical study.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Ankang Central Hospital
Ankang, Shaanxi, 725000
PengFei Yin, Ph. D, 86-0915-3214355, 943030513@qq.com
- Recruiting
3201 Hospital
Hanzhong, Shaanxi, 710005
Kun Liu, Ph. D, 86-0916-2383201, lk00086@sina.com
- Recruiting
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710005
Yongquan Shi, Ph. D, 86-029-84771535, shiyquan@fmmu.edu.cn
- Recruiting
Shaanxi Provincial Nuclear Industry 215 Hospital
Xianyang, Shaanxi, 712000
Lei Lei, Ph. D, 86-029-32088156, jiaozexuandll@163.com
About this study
Official title: Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.
- Conditions
- Acute Severe Ulcerative Colitis
- Being tested
- upadacitinib, Infliximab
- Keywords
- Acute severe ulcerative colitis, Upadacitinib, second-line treatments, infliximab, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upadacitinibDrug
receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily
InfliximabDrug
receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib group | Experimental | Upadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. Receives: Drug: upadacitinib |
| Infliximab group | Active comparator | receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response by day 7
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).
Measured: 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.
Secondary outcomes (12)
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.
Measured: day 14
clinical remission by day 28, day 42, and day 90
Total Mayo score ≤2 points and no individual subscore >1 point.
Measured: 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.
Measured: day 90
Endoscopic remission by day 90
MES score ≤1
Measured: day 90
Endoscopic+clinical response
Partial Mayo score ≤1 and MES ≤1
Measured: day 90
Clinical +FcP remission
Partial Mayo score ≤1 and FcP≤250mg/kg
Measured: day 90
Clinical +CRP remission
Partial Mayo score ≤1 and CRP≤5mg/L
Measured: 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.
Measured: 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.
Measured: day 90
Adverse Reactions
Adverse Reactions
Measured: day 90
IBD questionnaire scores
IBDQ and fatigue questionnaire scores，The total score ranges from 32 to 224 points. The closer the score is to 224, the less the patient is troubled by the disease and the higher their quality of life.
Measured: day 0 and day 90
PROMIS-Fatigue SF-7a
Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a.The total score ranges from 7 to 35 points. The higher the score, the more severe the fatigue caused by the disease, and timely attention to the patient's condition is needed.
Measured: day 0 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start20 Apr 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Severe Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550673
- Sponsor's protocol ID
- KY20252556-F-1-2
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Honap S, St-Pierre J, Colwill M, Patel K, Le Berre C, Caron B, Nogami A, Kobayashi T, Altwegg R, Laharie D, Hebuterne X, Nachury M, Roblin X, Uzzan M, Kotze PG, Lukas M, Vieujean S, D'Amico F, Albshesh A, Guillo L, Fumery M, Nancey S, Ye BD, Bergemalm D, Halfvarson J, Buisson A, Karmiris K, Rubin DT, Vicaut E, Peyrin-Biroulet L; ATTRACT Study Group. Comparative Effectiveness of Tofacitinib vs Upadacitinib for the Treatment of Acute Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Mar;24(3):784-793. doi: 10.1016/j.cgh.2025.07.025. Epub 2025 Jul 26.
PubMed 40721074Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):981-996. doi: 10.1016/S2468-1253(24)00200-0. Epub 2024 Sep 2.
PubMed 39236736
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07550673
- Acronym / sponsor ID
- KY20252556-F-1-2
- Conditions
- Acute Severe Ulcerative Colitis
- Keywords
- Acute severe ulcerative colitis, Upadacitinib, second-line treatments, infliximab, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib group | Experimental | Drug: upadacitinibUpadacitinib extended-release tablets 45 mg once daily for 8 weeks, then adjusted to 30 mg once daily. |
| Infliximab group | Active comparator | Drug: Infliximabreceiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with ASUC
- Aged 18 years or older.
- No gender restriction.
Key exclusion criteria (5 listed)
- Presence of contraindications, allergy, or intolerance to upadacitinib or infliximab.
- Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.
- Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.
- Pregnant or breastfeeding women.
- Unwilling to participate in the clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upadacitinibreceiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily | Drug | Upadacitinib group |
| Infliximabreceiving an initial dose of 5 mg/kg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose | Drug | Infliximab group |
Primary outcome
Clinical response by day 7
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 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).
12 secondary outcomes
clinical response by day 14
Time frame: day 14
clinical remission by day 28, day 42, and day 90
Time frame: day 28, day 42, and day 90
Endoscopic response by day 90
Time frame: day 90
Endoscopic remission by day 90
Time frame: day 90
Endoscopic+clinical response
Time frame: day 90
Clinical +FcP remission
Time frame: day 90
Clinical +CRP remission
Time frame: day 90
Histologic remission
Time frame: day 90
Histologic improvement
Time frame: day 90
Adverse Reactions
Time frame: day 90
IBD questionnaire scores
Time frame: day 0 and day 90
PROMIS-Fatigue SF-7a
Time frame: day 0 and day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 40721074Honap S, St-Pierre J, Colwill M, Patel K, Le Berre C, Caron B, Nogami A, Kobayashi T, Altwegg R, Laharie D, Hebuterne X, Nachury M, Roblin X, Uzzan M, Kotze PG, Lukas M, Vieujean S, D'Amico F, Albshesh A, Guillo L, Fumery M, Nancey S, Ye BD, Bergemalm D, Halfvarson J, Buisson A, Karmiris K, Rubin DT, Vicaut E, Peyrin-Biroulet L; ATTRACT Study Group. Comparative Effectiveness of Tofacitinib vs Upadacitinib for the Treatment of Acute Severe Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Mar;24(3):784-793. doi: 10.1016/j.cgh.2025.07.025. Epub 2025 Jul 26.
- Background: PubMed 39236736Choy MC, Li Wai Suen CFD, Con D, Boyd K, Pena R, Burrell K, Rosella O, Proud D, Brouwer R, Gorelik A, Liew D, Connell WR, Wright EK, Taylor KM, Pudipeddi A, Sawers M, Christensen B, Ng W, Begun J, Radford-Smith G, Garg M, Martin N, van Langenberg DR, Ding NS, Beswick L, Leong RW, Sparrow MP, De Cruz P. Intensified versus standard dose infliximab induction therapy for steroid-refractory acute severe ulcerative colitis (PREDICT-UC): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2024 Nov;9(11):981-996. doi: 10.1016/S2468-1253(24)00200-0. Epub 2024 Sep 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing upadacitinib and Infliximab in people with Acute Severe Ulcerative Colitis, run by Xijing Hospital of Digestive Diseases at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongquan Shi, Ph.D (86-029-84771535, shiyquan@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response by day 7 (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07550673, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.