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NCT06573944
IUS Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study
trial in Crohn's Disease in 34 participants. Status unknown.
30 June 2025
Quick facts
| Lead sponsor | The Third Xiangya Hospital of Central South University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 34 |
| Start date | 16 January 2024 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 September 2025 |
| Sites | 1 location across China |
Conditions studied
- Crohn's Disease — all drugs for Crohn's Disease →
- Upadacitinib — all drugs for Upadacitinib →
- Intestinal Ultrasound — all drugs for Intestinal Ultrasound →
- Predictors — all drugs for Predictors →
Sponsor
The Third Xiangya Hospital of Central South University
Who can join
Adults 18 to 80, any sex, with Crohn's Disease or Upadacitinib. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Crohn's disease (CD) is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood, and can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. Currently, the main therapeutic drugs for CD include aminosalicylic acid preparations, glucocorticoids, immunosuppressants, and biological agents. With the development of medical technology, small molecule preparations have begun to be applied to moderate-to-severe Crohn's disease. Upadacitinib is a novel oral small molecule agent that is a highly selective JAK-1 inhibitor. A large real-world study showed that in refractory moderate-to-severe CD, upadacitinib showed a clinical response rate of 76.5% and a clinical remission rate of 70.6% at 8 weeks of treatment. Intestinal ultrasound (IUS) is a noninvasive, reproducible, convenient, and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making process.The 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD. There are no validated indicators to predict the efficacy of upatinib treatment in patients with moderate-to-severe CD in the currently available studies. Currently, there are no national or international studies in which intestinal ultrasound predicts the efficacy of upatinib therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to upadacitinib in CD patients, with the aim of providing evidence to guide the development of individualized treatment plans.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Other The Third Xiangya Hospital of Central South University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06573944 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Third Xiangya Hospital of Central South University
- Last refreshed: 27 August 2024
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