Inflammatory Bowel Disease (IBD)NCT07697547
Efficacy and Safety of Low-Dose Upadacitinib Combined With Ustekinumab in the Treatment of Refractory Crohn's Disease
An observational study of Inflammatory Bowel Disease (IBD) and Crohn's Disease, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
A multicenter retrospective study evaluating the effectiveness and safety of ustekinumab combined with low-dose upadacitinib in patients with refractory Crohn's disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD), Crohn's Disease
- What is being tested?
- Upadacitinib and Ustekinumab (UST)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with refractory Crohn's disease from multiple inflammatory bowel disease centers in China who had prior anti-TNF therapy failure, intolerance, or contraindication and inadequate response to ustekinumab or upadacitinib monotherapy. Eligible patients received low-dose upadacitinib in combination with ustekinumab in routine clinical practice between July 1, 2023 and May 31, 2025, and were included in this retrospective real-world cohort study.
Who may be able to join
- Aged 18 to 65 years.
- Patients with a confirmed diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) criteria.
- Patients with prior failure, loss of response, intolerance, or contraindication to anti-TNF therapy, who subsequently had inadequate response to ustekinumab or upadacitinib monotherapy between July 1, 2023 and May 31, 2025.
- Active Crohn's disease defined by Harvey-Bradshaw Index (HBI) >4, or endoscopic disease activity with at least one segment having an SES-CD ulcer subscore ≥2. Postoperative endoscopic recurrence was defined as modified Rutgeerts score ≥i2b. For patients in whom the small bowel anastomosis could not be reached endoscopically, disease activity was assessed by the treating physician based on clinical symptoms, elevated inflammatory markers, and imaging findings.
- Patients who required dose reduction during full-dose upadacitinib treatment because of adverse events, or who had persistent clinical symptoms, elevated C-reactive protein, active endoscopic disease, postoperative recurrence, or active disease on imaging despite upadacitinib treatment.
- Patients with inadequate response or loss of response to ustekinumab treatment, defined by persistent clinical symptoms, elevated C-reactive protein, active endoscopic disease, postoperative recurrence, imaging evidence of active disease, or recurrence after initial response during maintenance therapy.
- Availability of inflammatory markers and imaging results within 3 months before initiation of combination therapy.
Who cannot join
- Patients receiving upadacitinib in combination with biologics other than ustekinumab.
- Patients receiving full-dose upadacitinib 45 mg/day in combination with ustekinumab.
- Patients with contraindications to upadacitinib, including hypersensitivity to the active substance or excipients, active tuberculosis or severe infection, malignancy, thromboembolic events, or severe hepatic impairment.
- Patients with severe infection, malignancy, pregnancy, or lactation.
- Patients with severe intestinal stricture, perforation, or intra-abdominal abscess that might require surgery and interruption of drug therapy during the study period.
- Patients considered unsuitable for the above treatment by the treating physician.
- Patients with incomplete data, inability to complete follow-up, or loss to follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
The Tenth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, 201505
About this study
A multicenter retrospective study evaluating the effectiveness and safety of ustekinumab combined with low-dose upadacitinib in patients with refractory Crohn's disease.
Read the detailed description
This is a multicenter, retrospective, real-world observational study conducted at several inflammatory bowel disease centers in China. The study is designed to evaluate the effectiveness and safety of ustekinumab (UST) combined with low-dose upadacitinib (UPA; 15 mg/day or 30 mg/day) in patients with moderate-to-severe active refractory Crohn's disease. Eligible patients received combination therapy between July 1, 2023 and December 31, 2025. Patients were required to have previously failed, been intolerant to, or experienced adverse events with anti-tumor necrosis factor therapy, followed by an inadequate response or intolerance to UST monotherapy or UPA 45 mg/day administered for 12 weeks. The combination regimen consisted of intravenous re-induction with UST and oral low-dose UPA at 15 mg/day or 30 mg/day for 12 weeks. Clinical response and clinical remission are assessed at weeks 12 to 16, while endoscopic response and endoscopic remission are assessed between weeks 12 and 24. Maintenance treatment after the initial 12-week combination period and safety outcomes through week 24 are also evaluated. Data are obtained retrospectively from existing medical records, and no study-specific intervention is assigned to participants.
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn's Disease
- Being tested
- Upadacitinib, Ustekinumab (UST)
- Keywords
- Ustekinumab, Upadacitinib, refractory Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Upadacitinib was administered orally at a low dose of 15 mg/day or 30 mg/day for at least 12 weeks in combination with ustekinumab.
Ustekinumab (UST)Drug
Ustekinumab was administered as intravenous induction based on body weight, followed by subcutaneous maintenance therapy at 90 mg every 8 weeks, in combination with low-dose upadacitinib.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose upadacitinib plus ustekinumab cohort | Patients with refractory Crohn's disease who received low-dose upadacitinib in combination with ustekinumab in a multicenter retrospective real-world cohort study. Receives: Drug: Upadacitinib; Drug: Ustekinumab (UST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate at Week 12 to Week 16
The proportion of patients achieving clinical remission at Week 12 to Week 16 after initiation of low-dose upadacitinib plus ustekinumab combination therapy. Clinical remission is defined as a Harvey-Bradshaw Index (HBI) score <5, or clinical remission as judged by the treating physician.
Measured: Week 12 to Week 16 after initiation of combination therapy
Secondary outcomes (2)
Endoscopic healing rate at Week 12 to Week 24
The proportion of patients achieving endoscopic healing at Week 12 to Week 24 after initiation of combination therapy. Endoscopic healing is defined as SES-CD ≤2, or modified Rutgeerts score <i2b in postoperative patients.
Measured: Week 12 to Week 24 after initiation of combination therapy
Endoscopic response rate at Week 12 to Week 24
The proportion of patients achieving endoscopic response at Week 12 to Week 24. Endoscopic response is defined as a >50% decrease in SES-CD from baseline, a decrease of ≥2 points from baseline in patients with a baseline SES-CD of 4, or a decrease of ≥1 point in the modified Rutgeerts score.
Measured: Week 12 to Week 24 after initiation of combination therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jul 2023
- Primary completion31 Dec 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Second Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, Xiaolei Wang, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697547
- Sponsor's protocol ID
- SHSY-IEC-6.0/25K32/P01
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-Dose Upadacitinib Combined With Ustekinumab in the Treatment of Refractory Crohn's Disease
- ClinicalTrials.gov ID
- NCT07697547
- Acronym / sponsor ID
- SHSY-IEC-6.0/25K32/P01
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn's Disease
- Keywords
- Ustekinumab, Upadacitinib, refractory Crohn's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, Second Affiliated Hospital of Zhengzhou University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 13 Jul 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.
A multicenter retrospective study evaluating the effectiveness and safety of ustekinumab combined with low-dose upadacitinib in patients with refractory Crohn's disease.
Detailed description
This is a multicenter, retrospective, real-world observational study conducted at several inflammatory bowel disease centers in China. The study is designed to evaluate the effectiveness and safety of ustekinumab (UST) combined with low-dose upadacitinib (UPA; 15 mg/day or 30 mg/day) in patients with moderate-to-severe active refractory Crohn's disease. Eligible patients received combination therapy between July 1, 2023 and December 31, 2025. Patients were required to have previously failed, been intolerant to, or experienced adverse events with anti-tumor necrosis factor therapy, followed by an inadequate response or intolerance to UST monotherapy or UPA 45 mg/day administered for 12 weeks. The combination regimen consisted of intravenous re-induction with UST and oral low-dose UPA at 15 mg/day or 30 mg/day for 12 weeks. Clinical response and clinical remission are assessed at weeks 12 to 16, while endoscopic response and endoscopic remission are assessed between weeks 12 and 24. Maintenance treatment after the initial 12-week combination period and safety outcomes through week 24 are also evaluated. Data are obtained retrospectively from existing medical records, and no study-specific intervention is assigned to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-dose upadacitinib plus ustekinumab cohort | – | Drug: Upadacitinib, Drug: Ustekinumab (UST)Patients with refractory Crohn's disease who received low-dose upadacitinib in combination with ustekinumab in a multicenter retrospective real-world cohort study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with refractory Crohn's disease from multiple inflammatory bowel disease centers in China who had prior anti-TNF therapy failure, intolerance, or contraindication and inadequate response to ustekinumab or upadacitinib monotherapy. Eligible patients received low-dose upadacitinib in combination with ustekinumab in routine clinical practice between July 1, 2023 and May 31, 2025, and were included in this retrospective real-world cohort study.
Key inclusion criteria (7 listed)
- Aged 18 to 65 years.
- Patients with a confirmed diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) criteria.
- Patients with prior failure, loss of response, intolerance, or contraindication to anti-TNF therapy, who subsequently had inadequate response to ustekinumab or upadacitinib monotherapy between July 1, 2023 and May 31, 2025.
- Active Crohn's disease defined by Harvey-Bradshaw Index (HBI) >4, or endoscopic disease activity with at least one segment having an SES-CD ulcer subscore ≥2. Postoperative endoscopic recurrence was defined as modified Rutgeerts score ≥i2b. For patients in whom the small bowel anastomosis could not be reached endoscopically, disease activity was assessed by the treating physician based on clinical symptoms, elevated inflammatory markers, and imaging findings.
- Patients who required dose reduction during full-dose upadacitinib treatment because of adverse events, or who had persistent clinical symptoms, elevated C-reactive protein, active endoscopic disease, postoperative recurrence, or active disease on imaging despite upadacitinib treatment.
Key exclusion criteria (7 listed)
- Patients receiving upadacitinib in combination with biologics other than ustekinumab.
- Patients receiving full-dose upadacitinib 45 mg/day in combination with ustekinumab.
- Patients with contraindications to upadacitinib, including hypersensitivity to the active substance or excipients, active tuberculosis or severe infection, malignancy, thromboembolic events, or severe hepatic impairment.
- Patients with severe infection, malignancy, pregnancy, or lactation.
- Patients with severe intestinal stricture, perforation, or intra-abdominal abscess that might require surgery and interruption of drug therapy during the study period.
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 |
|---|---|---|
| UpadacitinibUpadacitinib was administered orally at a low dose of 15 mg/day or 30 mg/day for at least 12 weeks in combination with ustekinumab. | Drug | Low-dose upadacitinib plus ustekinumab cohort |
| Ustekinumab (UST)Ustekinumab was administered as intravenous induction based on body weight, followed by subcutaneous maintenance therapy at 90 mg every 8 weeks, in combination with low-dose upadacitinib. | Drug | Low-dose upadacitinib plus ustekinumab cohort |
Primary outcome
Clinical remission rate at Week 12 to Week 16
Time frame: Week 12 to Week 16 after initiation of combination therapy
The proportion of patients achieving clinical remission at Week 12 to Week 16 after initiation of low-dose upadacitinib plus ustekinumab combination therapy. Clinical remission is defined as a Harvey-Bradshaw Index (HBI) score <5, or clinical remission as judged by the treating physician.
2 secondary outcomes
Endoscopic healing rate at Week 12 to Week 24
Time frame: Week 12 to Week 24 after initiation of combination therapy
Endoscopic response rate at Week 12 to Week 24
Time frame: Week 12 to Week 24 after initiation of combination therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Disease (IBD)
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (IBD) and Crohn's Disease, run by Shanghai 10th People's Hospital at 1 site 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate at Week 12 to Week 16 (time frame: Week 12 to Week 16 after initiation of combination therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.