Actively Recruiting
Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2026-02-23
214
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of dual-target therapy (Ustekinumab combined with Upadacitinib) versus intensified Ustekinumab monotherapy in patients with Crohn's disease who have an inadequate response to standard doses of Ustekinumab. The main questions it aims to answer are: Is dual-target therapy more effective than intensified Ustekinumab monotherapy in achieving endoscopic remission in Crohn's disease patients? Is dual-target therapy as safe as intensified Ustekinumab monotherapy in terms of adverse events? Participants will: Receive either dual-target therapy (Ustekinumab combined with Upadacitinib) or intensified Ustekinumab monotherapy. Attend regular clinic visits for monitoring and assessments. Complete questionnaires about their symptoms and quality of life. Undergo routine blood tests and endoscopic evaluations to assess disease activity. Researchers will compare the dual-target therapy group to the intensified Ustekinumab monotherapy group to see if dual-target therapy is more effective in achieving endoscopic remission and is as safe in terms of adverse events.
CONDITIONS
Official Title
Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 70 years at baseline (week 0)
- Active Crohn's disease at baseline with CDAI > 150 and specific endoscopic activity criteria
- Evidence of inflammation with CRP > 10 mg/L, fecal calprotectin > 250 bcg/g, or active disease confirmed by imaging
- Previous primary non-response or loss of response to TNFi and at least 16-24 weeks of standard-dose ustekinumab treatment with ongoing active disease
- Ability and willingness to provide written informed consent and follow study protocol
- Good general health as determined by medical history, lab tests, physical exam, chest X-ray, and ECG during screening
You will not qualify if you...
- Known allergies to Ustekinumab or Upadacitinib excipients or components
- Untreated or unresolved high-grade dysplasia or colon cancer
- Active infections at screening or baseline including pneumonia, pyelonephritis, or herpes zoster, or chronic infections making the participant unsuitable
- Need for surgical intervention for Crohn's disease during the study period
- Thrombosis detected by limb venous Doppler ultrasound or D-dimer screening
- History or signs of lymphoproliferative disorders such as lymphoma, lymphadenopathy, or splenomegaly
- Known congenital or acquired immunodeficiency including HIV or organ transplantation
- Positive pregnancy test at screening or baseline
- Breastfeeding or planning pregnancy during the study
- History of drug or alcohol abuse within 1 year prior to screening
- Any other reason deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wei Wang
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
W
Wei Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here