RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Upadacitinib for Crohn Disease (CD)

This multicenter, randomly assigned, controlled trial aims to measure the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07510191 · Sixth Affiliated Hospital, Sun Yat-sen University · enrollment listed as 312

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Upadacitinib, Infliximab Dose Intensification, or Adalimumab Dose Intensification. The registry lists allocation as randomized. This multicenter, randomly assigned, controlled trial aims to measure the how well it works 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.

They plan to enroll about 312 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Upadacitinib, Infliximab Dose Intensification, Adalimumab Dose Intensification, Standard-Dose infliximab, Standard-Dose Adalimumab

Primary outcome (registry wording): Clinical remission rate

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
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
At enrollment, the participant must simultaneously meet both requirements:
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, how well it works analysis, and exploratory research

Who the registry excludes

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
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
Major bowel resection, stoma creation, or other major abdominal surgery within 3 months prior to enrollment, if judged by the investigator to affect how well it works 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 how well it works assessment

Public study contact (from the registry)

Wei Wang, MD

86-18702046420

wangw239@mail.sysu.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (recruiting)

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FAQ about this NCT record

Is NCT07510191 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07510191?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07510191?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary