Actively Recruiting
TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-04-22
312
Participants Needed
1
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, any sex
- Confirmed diagnosis of Crohn's disease based on clinical, imaging, endoscopy, and pathology evaluations
- Prior treatment with TNF-alpha inhibitors (infliximab, adalimumab, or biosimilars) for at least 12 weeks with partial response and room for optimization
- Active Crohn's disease with Crohn's Disease Activity Index (CDAI) between 150 and 450
- Objective evidence of active inflammation shown by endoscopy, elevated C-reactive protein, fecal calprotectin of 250 mcg/g or higher, or imaging
- Willingness and ability to provide informed consent and comply with study requirements
You will not qualify if you...
- No improvement after adequate TNF-alpha inhibitor induction therapy indicating mechanistic non-response
- Confirmed immunogenic clearance with anti-drug antibodies and low or undetectable drug levels
- Symptoms mainly caused by non-inflammatory conditions like irritable bowel syndrome or bile acid diarrhea
- Prior use of JAK inhibitors including upadacitinib or known allergy to study drugs
- Severe intestinal complications such as uncontrolled abscess, perforation, severe stricture, or fistula
- Major bowel surgery within 3 months before enrollment affecting safety or efficacy
- Active or high-risk infections including tuberculosis, herpes zoster, HIV, or other immunodeficiencies
- Severe dysfunction of major organs making participation unsafe
- History of gastrointestinal or other cancers affecting study safety
- Pregnant, breastfeeding, or unwilling to use contraception during the study
- Severe psychiatric or neurological disorders impairing consent or adherence
- Participation in another interventional study within 30 days
- Any other condition making the participant unsuitable as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
W
Wei Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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