Value of IUS in Predicting Vedolizumab Efficacy and Assessing Transmural Healing in Early Crohn's Disease: A Multicenter, Prospective Study

NCT ID: NCT07093294

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-09-30

Brief Summary

Crohn's disease(CD) is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood,characterized by transmural inflammation , can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. In recent years, the incidence of CD has increased rapidly, causing a heavy social and economic burden. 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, providing new treatment options for patients with Crohn's disease.

Vedolizumab, a humanized monoclonal antibody.the GEMINI study demonstrated its superior efficacy over placebo in inducing and maintaining clinical remission. And the VERSIFY study confirmed its advantage in achieving mucosal healing, with a transmural healing rate of 29.1% at week 52.

Intestinal ultrasound 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. Multiple studies have shown that most ultrasound markers normalize within 12 weeks of treatment initiation, and in particular, normalization of bowel wall thickness is highly correlated with clinical response at 12 weeks. There are no validated indicators to predict the efficacy of upadacitinib 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 and assesses the transmural healing of vedolizumab therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to vedolizumab in early CD patients, with the aim of providing evidence to guide the development of individualized treatment plans.

Detailed Description

Crohn's disease(CD) is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood,characterized by transmural inflammation , can present with serious complications such as intestinal obstruction, perforation, abdominal abscesses, and fistulae. In recent years, the incidence of CD has increased rapidly, causing a heavy social and economic burden. Patients often experience prolonged, relapsing disease courses , with approximately 30% developing irreversible damage such as intestinal strictures or perforation at diagnosis due to delayed detection, resulting in substantial disease burden.Currently, the main therapeutic drugs for CD include aminosalicylic acid preparations, glucocorticoids, immunosuppressants, and biological agents. With the development of medical technology, biologics have begun to be applied to moderate-to-severe Crohn's disease, providing new treatment options for patients with Crohn's disease.However, subclinical inflammatory activity persists in some patients , and long-term use carries risks of secondary infections, malignancies, and loss of response. Therefore, accurately predicting treatment response to biologics and assessing transmural healing in early CD patients remains an urgent clinical challenge.

Vedolizumab, a humanized monoclonal antibody,specifically targets α4β7 integrin to block lymphocyte migration to gut mucosa, thereby suppressing local inflammation and improving CD symptoms.The phase 3 GEMINI trial by Sands BE et al. demonstrated vedolizumab's superiority over placebo in inducing and maintaining clinical remission. The VERSIFY study further confirmed its efficacy in achieving mucosal healing, with a 29.1% transmural healing rate at week 52 versus placebo . However, vedolizumab may increase infection risk, with common adverse effects including nasopharyngitis, headache, and arthralgia. Approximately 30% of patients exhibit primary non-response, highlighting the importance of early response identification and longitudinal monitoring Intestinal ultrasound 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. Multiple studies have shown that most ultrasound markers normalize within 12 weeks of treatment initiation, and in particular, normalization of bowel wall thickness is highly correlated with clinical response at 12 weeks. There are no validated indicators to predict the efficacy of upadacitinib 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 and assesses the transmural healing of vedolizumab therapy. Therefore, we propose for the first time that intestinal ultrasound be used as a method to predict the response to vedolizumab in early CD patients, with the aim of providing evidence to guide the development of individualized treatment plans.

Conditions

Crohn Disease (CD); Vedolizumab; Intestinal Ultrasound; Predictor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years and ≤ 80 years;
• Early CD patients (disease duration ≤18 months, biologic-naïve and treatment-naïve for advanced therapies, without complications such as fistulas or strictures)
• Vedolizumab therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound,;
• No history of intestinal surgery;
• Clearly understand, voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria

• Contraindications to vedolizumab: allergy, active tuberculosis or other active infections, moderate-to-severe heart failure (NYHA grade III/ IV), demyelinating lesions of the nervous system, live vaccination within the last 3 months, pregnancy and lactation;
• Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia;
• Hypersensitivity to the components of SonoVue contrast media.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of University of South China

OTHER

Sponsor Role: collaborator

The First People's Hospital of Changde City

OTHER

Sponsor Role: collaborator

The Central Hospital of Shaoyang City

UNKNOWN

Sponsor Role: collaborator

First People's Hospital of Chenzhou

OTHER

Sponsor Role: collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Li Tian, MD

Li Tian,MD[fu3tianli]

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Tian Li

Role: CONTACT

f3tianli@outlook.com

0731-13574843423

Yuwei Wu

Role: CONTACT

wywer0612@163.com

0731-13308466056

Facility Contacts

Tian Li

Role: primary

wywer0612@163.com

0731-13308466056

Other Identifiers

fu3tianli7

Identifier Type: -

Identifier Source: org_study_id