Crohn Disease (CD)Phase 4CDNCT07510191
TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
A Phase 4 study testing Upadacitinib, Infliximab Dose Intensification and Adalimumab Dose Intensification in people with Crohn Disease (CD), run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- Upadacitinib, Infliximab Dose Intensification and Adalimumab Dose Intensification
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2029
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for enrollment:
- Age 18-65 years, regardless of sex.
- Established diagnosis of Crohn's disease (CD) based on a comprehensive assessment including clinical manifestations, imaging, endoscopy, histopathology, and other relevant evaluations, and meeting currently accepted domestic and international diagnostic criteria.
- Prior exposure to TNFα inhibitors (including infliximab, adalimumab, or its biosimilars) for at least 12 weeks, and currently receiving a standard-dose treatment regimen. After comprehensive evaluation by the investigators, the participant is considered to have partial response to TNFα inhibitor therapy with residual room for optimization. This is defined as failure to achieve the prespecified treatment target after standard induction and/or maintenance therapy, while still being considered by the investigator to have potential for further optimization. Eligible participants should meet either of the following: (1)Loss of response (LOR): The participant previously achieved clinical remission and/or objective improvement after TNFα inhibitor treatment, but subsequently developed recurrent disease activity during the maintenance phase. Based on the prior response trajectory, current objective evidence of disease activity, treatment adherence, and available reactive therapeutic drug monitoring (TDM) results, the investigator judges that the participant has not developed complete pharmacodynamic failure to TNFi, and still has room for further therapeutic optimization. (2)Primary inadequate response: After completion of standard induction therapy, the participant achieved some but insufficient improvement compared with pretreatment baseline, defined as meeting at least one of the following: ①CDAI decrease of ≥100 points, but CDAI remains ≥150, ②SES-CD decrease of ≥50%, but active ulcerative lesions persist or endoscopic remission has not been achieved, ③CRP and/or FCP decrease of ≥50%, but inflammatory markers have not normalized (e.g., FCP ≥250 μg/g), ④Based on a comprehensive assessment of symptoms, endoscopy, inflammatory biomarkers, and imaging, the investigator determines that the participant has achieved partial response to TNFi but has not reached the anticipated treatment target, with further room for optimization.
- Active Crohn's disease with objective evidence of active inflammation, defined as meeting all of the following: 150 ≤ CDAI < 450; at least one of the following objective indicators of active inflammation: (1)Endoscopy showing active ulcerative lesions, (2)Elevated inflammatory markers such as C-reactive protein (CRP), (3)Fecal calprotectin (FCP) ≥250 μg/g, (4)Imaging evidence of active intestinal inflammation, such as CTE, MRE, or intestinal ultrasound.
- At enrollment, the participant must simultaneously meet both requirements:
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- Partial response to TNFα inhibitor therapy with residual room for optimization, and
- Objective evidence of active inflammation at the current active stage of CD. Baseline TDM and pharmacokinetic assessment are feasible at enrollment, and relevant results may be used for baseline stratification, efficacy analysis, and exploratory research.
- The participant fully understands the study objectives, procedures, and potential risks, voluntarily agrees to participate, and has signed the written informed consent form.
Who cannot join
- Participants meeting any of the following criteria will be excluded from the study:
- No improvement at all after adequate induction therapy with a TNFα inhibitor, with investigator judgment indicating clear mechanistic non-response and minimal likelihood of benefit from further optimization.
- Documented immunogenic clearance confirmed by therapeutic drug monitoring (TDM), defined as positive anti-drug antibodies against a TNFα inhibitor with extremely low or undetectable trough drug levels, and judged by the investigator to be unsuitable for continued treatment with the original TNFα inhibitor.
- Current symptoms are judged, after comprehensive evaluation, to be caused primarily by non-inflammatory factors, with no objective evidence of active inflammation, such as irritable bowel syndrome, bile acid diarrhea, small intestinal bacterial overgrowth, or other non-inflammatory causes.
- Prior exposure to JAK inhibitors (including but not limited to upadacitinib), known hypersensitivity to any component of the investigational treatment, or other clear contraindications to study treatment.
- Presence of severe intestinal complications rendering the participant unsuitable for this study, including but not limited to inadequately controlled active intra-abdominal abscess, intestinal perforation, severe stricture requiring urgent surgical intervention, or severe active intestinal fistula.
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- Major bowel resection, stoma creation, or other major abdominal surgery within 3 months prior to enrollment, if judged by the investigator to affect efficacy assessment or safety evaluation.
- Active infection or high risk of severe infection, including but not limited to active tuberculosis, uncontrolled serious bacterial/fungal/viral infection, active herpes zoster, HBV reactivation, HIV infection, or other clinically significant immunodeficiency states.
- Severe dysfunction of major organs, such as significant hepatic impairment, severe renal insufficiency, severe cardiac insufficiency, or other serious underlying diseases judged by the investigator to make participation inappropriate.
- History of gastrointestinal malignancy, or presence of any other malignant disease that may significantly affect study safety or efficacy assessment.
- Pregnant or breastfeeding women, or women planning pregnancy who are unwilling to use effective contraception during the study period.
- Severe psychiatric or neurologic disorders that may impair the ability to provide informed consent, adhere to treatment, or complete study follow-up.
- Participation in another interventional clinical study within 30 days prior to enrollment, where the prior intervention may affect the efficacy or safety assessment of this study.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Wei Wang, MD, 86-18702046420, wangw239@mail.sysu.edu.cn
About this study
Official title: Efficacy and Safety of Standard-Dose TNF Inhibitor Plus Low-Dose Upadacitinib Versus TNF Inhibitor Intensification for Crohn's Disease With Suboptimal Response to Standard-Dose TNF Inhibitors: A Multicenter, Randomized, Controlled Trial
This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy. Eligible participants are adults with active Crohn's disease receiving standard-dose infliximab or adalimumab who remain inadequately controlled despite ongoing treatment. Participants will be randomly assigned in a 1:1 ratio to either continue standard-dose TNFi with oral upadacitinib 15 mg once daily, or receive TNFi dose intensification according to the protocol. Clinical assessments will be performed at baseline and during follow-up, with the primary endpoint assessed at Week 14. The primary outcome is the proportion of participants achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score <150 at Week 14. Secondary outcomes include clinical response, endoscopic response and remission, changes in inflammatory biomarkers such as C-reactive protein and fecal calprotectin, quality of life, and safety outcomes including adverse events and serious adverse events. Participants will continue follow-up after Week 14 to evaluate treatment durability and longer-term safety. This study is designed to determine whether a dual-target strategy with standard-dose TNFi plus low-dose upadacitinib provides superior short-term efficacy and acceptable safety compared with conventional TNFi intensification in Crohn's disease patients with insufficient benefit from standard-dose TNFi therapy.
- Conditions
- Crohn Disease (CD)
- Being tested
- Upadacitinib, Infliximab Dose Intensification, Adalimumab Dose Intensification, Standard-Dose infliximab, Standard-Dose Adalimumab
- Keywords
- Crohn Disease, TNF inhibitor, Infliximab, Adalimumab, Upadacitinib, Dose intensification, Dual-target therapy, Multicenter randomized controlled trial
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Upadacitinib will be administered orally in combination with ongoing standard-dose TNF inhibitor therapy in the experimental arm. The initial dose is 15 mg once daily for 14 weeks. If inflammatory biomarkers, including C-reactive protein or fecal calprotectin, do not decrease by at least 30% from baseline at Week 4 and treatment is well tolerated, the dose may be increased to 30 mg once daily according to the study protocol
Infliximab Dose IntensificationDrug
In the active comparator arm, infliximab dose intensification will be performed by shortening the dosing interval from every 8 weeks to every 4 weeks at 5 mg/kg, according to the study protocol.
Adalimumab Dose IntensificationDrug
In the active comparator arm, adalimumab dose intensification will be performed by increasing the dose from 40 mg every 2 weeks to 80 mg every 2 weeks, according to the study protocol.
Standard-Dose infliximabDrug
In the experimental arm, participants will continue standard-dose infliximab at 5 mg/kg every 8 weeks.
Standard-Dose AdalimumabDrug
In the experimental arm, participants will continue standard-dose adalimumab at 40 mg every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Standard-Dose TNFi Plus Low-Dose Upadacitinib | Experimental | Participants will continue their current standard-dose TNF inhibitor therapy and receive oral upadacitinib. Standard-dose TNF inhibitor therapy includes infliximab 5 mg/kg intravenously every 8 weeks or adalimumab 40 mg subcutaneously every 2 weeks, with no dose intensification or switching during the study. Upadacitinib will be initiated at 15 mg orally once daily for 14 weeks. If inflammatory biomarkers such as C-reactive protein or fecal calprotectin do not decrease by at least 30% from baseline at Week 4 and treatment is well tolerated, the dose may be increased to 30 mg once daily according to the protocol. Receives: Drug: Upadacitinib; Drug: Standard-Dose infliximab; Drug: Standard-Dose Adalimumab |
| TNFi Dose Intensification | Active comparator | Participants will continue their current TNF inhibitor with protocol-defined dose intensification. For infliximab, the dosing interval will be shortened from every 8 weeks to every 4 weeks at 5 mg/kg intravenously. For adalimumab, the dose will be increased from 40 mg every 2 weeks to 80 mg every 2 weeks by subcutaneous injection. No switching to another TNF inhibitor, no additional biologic therapy, and no new JAK inhibitor will be permitted during the intervention period. The treatment period is 14 weeks. Receives: Drug: Infliximab Dose Intensification; Drug: Adalimumab Dose Intensification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
The proportion of participants achieving clinical remission at Week 14, defined as a Crohn's Disease Activity Index (CDAI) score <150.
Measured: Week 14
Secondary outcomes (12)
Clinical response rate
Clinical response is defined as a decrease of at least 100 points from baseline in the Crohn's Disease Activity Index (CDAI) score.
Measured: Weeks 14 and 52
Endoscopic remission rate
The proportion of participants achieving endoscopic remission, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) <3.
Measured: Weeks 14 and 52
Endoscopic response rate
The proportion of participants achieving endoscopic response, defined as a ≥50% reduction in SES-CD from baseline.
Measured: Weeks 14 and 52
Mucosal healing rate
The proportion of participants achieving mucosal healing, defined as complete absence of ulceration in all examined bowel segments. This outcome will be evaluated among participants who undergo ileocolonoscopy at the specified time points.
Measured: Weeks 14 and 52
C-reactive protein (CRP) response rate
The proportion of participants achieving a ≥50% reduction in CRP levels from baseline or normalization to within the upper limit of normal.
Measured: Weeks 14 and 52
Fecal calprotectin (FCP) response rate
The proportion of participants achieving a ≥50% reduction in fecal calprotectin levels from baseline or normalization (<250 μg/g).
Measured: Weeks 14 and 52
Imaging response rate
Cross-sectional imaging response is defined as improvement from baseline on CTE or MRE in the affected bowel segment, including at least one of the following: a ≥25% reduction in bowel wall thickness, reduction in mural hyperenhancement or mural edema, or reduction in associated inflammatory changes.
Measured: Weeks 14 and 52
Imaging remission rate
Proportion of participants achieving radiologic remission at Week 12, assessed primarily by CTE and, when available, MRE, defined as minimal or absent active transmural inflammatory findings on cross-sectional imaging, including absence or near-complete resolution of mural hyperenhancement, mural stratification and/or mural edema, comb sign, and perienteric inflammatory change, without radiologic progression or new penetrating inflammatory complications. In participants undergoing MRE, radiologic remission may additionally be defined as a MaRIA score <7.
Measured: Weeks 14 and 52
Bowel ultrasound response rate
Proportion of participants achieving bowel ultrasound response at Week 12, defined as a reduction in bowel wall thickness and/or a decrease in bowel wall vascularity (Limberg score) compared with baseline.
Measured: Weeks 14 and 52
Incidence of adverse events and serious adverse events
Safety will be assessed by the incidence of adverse events (AEs) and serious adverse events (SAEs) during the study period. All AEs and SAEs will be recorded and graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Weeks 14 and 52
Proportion of participants discontinuing study treatment due to adverse events
Treatment tolerability will be assessed by the proportion of participants who discontinue study treatment due to adverse events during the study period.
Measured: Weeks 14 and 52
Incidence of treatment-related adverse events
Treatment-related adverse events will be assessed during the study period based on investigator attribution
Measured: Weeks 14 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants with Crohn's disease and suboptimal response to standard-dose TNF inhibitor therapy will be randomized in a 1:1 ratio to one of two parallel treatment arms: continuation of standard-dose TNF inhibitor therapy plus low-dose upadacitinib, or TNF inhibitor dose intensification. Participants will remain in their assigned treatment arm throughout the study, and outcomes will be compared between groups at prespecified follow-up visits.2
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Min, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510191
- Sponsor's protocol ID
- 2026ZSLYEC-158
- Acronym
- CD
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a multi-center study involving detailed clinical, imaging, endoscopic, surgical, and pathology data from patients with complicated Crohn's disease, and there is a potential risk of participant re-identification despite de-identification. Data sharing is also subject to local ethics approval, institutional policy, and participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Standard-Dose TNF Inhibitor Plus Low-Dose Upadacitinib Versus TNF Inhibitor Intensification for Crohn's Disease With Suboptimal Response to Standard-Dose TNF Inhibitors: A Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07510191
- Acronym / sponsor ID
- CD / 2026ZSLYEC-158
- Conditions
- Crohn Disease (CD)
- Keywords
- Crohn Disease, TNF inhibitor, Infliximab, Adalimumab, Upadacitinib, Dose intensification, Dual-target therapy, Multicenter randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 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 multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy. Eligible participants are adults with active Crohn's disease receiving standard-dose infliximab or adalimumab who remain inadequately controlled despite ongoing treatment. Participants will be randomly assigned in a 1:1 ratio to either continue standard-dose TNFi with oral upadacitinib 15 mg once daily, or receive TNFi dose intensification according to the protocol. Clinical assessments will be performed at baseline and during follow-up, with the primary endpoint assessed at Week 14. The primary outcome is the proportion of participants achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score <150 at Week 14. Secondary outcomes include clinical response, endoscopic response and remission, changes in inflammatory biomarkers such as C-reactive protein and fecal calprotectin, quality of life, and safety outcomes including adverse events and serious adverse events. Participants will continue follow-up after Week 14 to evaluate treatment durability and longer-term safety. This study is designed to determine whether a dual-target strategy with standard-dose TNFi plus low-dose upadacitinib provides superior short-term efficacy and acceptable safety compared with conventional TNFi intensification in Crohn's disease patients with insufficient benefit from standard-dose TNFi therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with Crohn's disease and suboptimal response to standard-dose TNF inhibitor therapy will be randomized in a 1:1 ratio to one of two parallel treatment arms: continuation of standard-dose TNF inhibitor therapy plus low-dose upadacitinib, or TNF inhibitor dose intensification. Participants will remain in their assigned treatment arm throughout the study, and outcomes will be compared between groups at prespecified follow-up visits.2
| Arm | Type | Receives |
|---|---|---|
| Standard-Dose TNFi Plus Low-Dose Upadacitinib | Experimental | Drug: Upadacitinib, Drug: Standard-Dose infliximab, Drug: Standard-Dose AdalimumabParticipants will continue their current standard-dose TNF inhibitor therapy and receive oral upadacitinib. Standard-dose TNF inhibitor therapy includes infliximab 5 mg/kg intravenously every 8 weeks or adalimumab 40 mg subcutaneously every 2 weeks, with no dose intensification or switching during the study. Upadacitinib will be initiated at 15 mg orally once daily for 14 weeks. If inflammatory biomarkers such as C-reactive protein or fecal calprotectin do not decrease by at least 30% from baseline at Week 4 and treatment is well tolerated, the dose may be increased to 30 mg once daily according to the protocol. |
| TNFi Dose Intensification | Active comparator | Drug: Infliximab Dose Intensification, Drug: Adalimumab Dose IntensificationParticipants will continue their current TNF inhibitor with protocol-defined dose intensification. For infliximab, the dosing interval will be shortened from every 8 weeks to every 4 weeks at 5 mg/kg intravenously. For adalimumab, the dose will be increased from 40 mg every 2 weeks to 80 mg every 2 weeks by subcutaneous injection. No switching to another TNF inhibitor, no additional biologic therapy, and no new JAK inhibitor will be permitted during the intervention period. The treatment period is 14 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-65 years, regardless of sex.
- Established diagnosis of Crohn's disease (CD) based on a comprehensive assessment including clinical manifestations, imaging, endoscopy, histopathology, and other relevant evaluations, and meeting currently accepted domestic and international diagnostic criteria.
- Prior exposure to TNFα inhibitors (including infliximab, adalimumab, or its biosimilars) for at least 12 weeks, and currently receiving a standard-dose treatment regimen. After comprehensive evaluation by the investigators, the participant is considered to have partial response to TNFα inhibitor therapy with residual room for optimization. This is defined as failure to achieve the prespecified treatment target after standard induction and/or maintenance therapy, while still being considered by the investigator to have potential for further optimization. Eligible participants should meet either of the following: (1)Loss of response (LOR): The participant previously achieved clinical remission and/or objective improvement after TNFα inhibitor treatment, but subsequently developed recurrent disease activity during the maintenance phase. Based on the prior response trajectory, current objective evidence of disease activity, treatment adherence, and available reactive therapeutic drug monitoring (TDM) results, the investigator judges that the participant has not developed complete pharmacodynamic failure to TNFi, and still has room for further therapeutic optimization. (2)Primary inadequate response: After completion of standard induction therapy, the participant achieved some but insufficient improvement compared with pretreatment baseline, defined as meeting at least one of the following: ①CDAI decrease of ≥100 points, but CDAI remains ≥150, ②SES-CD decrease of ≥50%, but active ulcerative lesions persist or endoscopic remission has not been achieved, ③CRP and/or FCP decrease of ≥50%, but inflammatory markers have not normalized (e.g., FCP ≥250 μg/g), ④Based on a comprehensive assessment of symptoms, endoscopy, inflammatory biomarkers, and imaging, the investigator determines that the participant has achieved partial response to TNFi but has not reached the anticipated treatment target, with further room for optimization.
- Active Crohn's disease with objective evidence of active inflammation, defined as meeting all of the following: 150 ≤ CDAI < 450; at least one of the following objective indicators of active inflammation: (1)Endoscopy showing active ulcerative lesions, (2)Elevated inflammatory markers such as C-reactive protein (CRP), (3)Fecal calprotectin (FCP) ≥250 μg/g, (4)Imaging evidence of active intestinal inflammation, such as CTE, MRE, or intestinal ultrasound.
- At enrollment, the participant must simultaneously meet both requirements:
Key exclusion criteria (14 listed)
- No improvement at all after adequate induction therapy with a TNFα inhibitor, with investigator judgment indicating clear mechanistic non-response and minimal likelihood of benefit from further optimization.
- Documented immunogenic clearance confirmed by therapeutic drug monitoring (TDM), defined as positive anti-drug antibodies against a TNFα inhibitor with extremely low or undetectable trough drug levels, and judged by the investigator to be unsuitable for continued treatment with the original TNFα inhibitor.
- Current symptoms are judged, after comprehensive evaluation, to be caused primarily by non-inflammatory factors, with no objective evidence of active inflammation, such as irritable bowel syndrome, bile acid diarrhea, small intestinal bacterial overgrowth, or other non-inflammatory causes.
- Prior exposure to JAK inhibitors (including but not limited to upadacitinib), known hypersensitivity to any component of the investigational treatment, or other clear contraindications to study treatment.
- Presence of severe intestinal complications rendering the participant unsuitable for this study, including but not limited to inadequately controlled active intra-abdominal abscess, intestinal perforation, severe stricture requiring urgent surgical intervention, or severe active intestinal fistula.
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 will be administered orally in combination with ongoing standard-dose TNF inhibitor therapy in the experimental arm. The initial dose is 15 mg once daily for 14 weeks. If inflammatory biomarkers, including C-reactive protein or fecal calprotectin, do not decrease by at least 30% from baseline at Week 4 and treatment is well tolerated, the dose may be increased to 30 mg once daily according to the study protocol | Drug | Standard-Dose TNFi Plus Low-Dose Upadacitinib |
| Infliximab Dose IntensificationIn the active comparator arm, infliximab dose intensification will be performed by shortening the dosing interval from every 8 weeks to every 4 weeks at 5 mg/kg, according to the study protocol. | Drug | TNFi Dose Intensification |
| Adalimumab Dose IntensificationIn the active comparator arm, adalimumab dose intensification will be performed by increasing the dose from 40 mg every 2 weeks to 80 mg every 2 weeks, according to the study protocol. | Drug | TNFi Dose Intensification |
| Standard-Dose infliximabIn the experimental arm, participants will continue standard-dose infliximab at 5 mg/kg every 8 weeks. | Drug | Standard-Dose TNFi Plus Low-Dose Upadacitinib |
| Standard-Dose AdalimumabIn the experimental arm, participants will continue standard-dose adalimumab at 40 mg every 2 weeks. | Drug | Standard-Dose TNFi Plus Low-Dose Upadacitinib |
Primary outcome
Clinical remission rate
Time frame: Week 14
The proportion of participants achieving clinical remission at Week 14, defined as a Crohn's Disease Activity Index (CDAI) score <150.
12 secondary outcomes
Clinical response rate
Time frame: Weeks 14 and 52
Endoscopic remission rate
Time frame: Weeks 14 and 52
Endoscopic response rate
Time frame: Weeks 14 and 52
Mucosal healing rate
Time frame: Weeks 14 and 52
C-reactive protein (CRP) response rate
Time frame: Weeks 14 and 52
Fecal calprotectin (FCP) response rate
Time frame: Weeks 14 and 52
Imaging response rate
Time frame: Weeks 14 and 52
Imaging remission rate
Time frame: Weeks 14 and 52
Bowel ultrasound response rate
Time frame: Weeks 14 and 52
Incidence of adverse events and serious adverse events
Time frame: Weeks 14 and 52
Proportion of participants discontinuing study treatment due to adverse events
Time frame: Weeks 14 and 52
Incidence of treatment-related adverse events
Time frame: Weeks 14 and 52
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 9 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a multi-center study involving detailed clinical, imaging, endoscopic, surgical, and pathology data from patients with complicated Crohn's disease, and there is a potential risk of participant re-identification despite de-identification. Data sharing is also subject to local ethics approval, institutional policy, and participant consent.
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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.
1 site 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, Infliximab Dose Intensification and Adalimumab Dose Intensification in people with Crohn Disease (CD), run by Sixth Affiliated Hospital, Sun Yat-sen University 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 9 inclusion and 14 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 9 Jun 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.
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 Wei Wang, MD (86-18702046420, wangw239@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission rate (time frame: Week 14). 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 9 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.