Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease

NCT05387031 | Recruiting FDA Drug

• 1 other identifier: 2022-0276
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 8

Brief Summary

This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.

Conditions

Stricture; Bowel; Crohn Disease; Intestinal Stricture

Keywords

Crohn Disease; intestinal stricture; Ustekinumab; integrated medicine therapy; cohort study

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment success at week 52

  The primary endpoint was the success at week 52, defined as ustekinumab continuation with all the following criteria: (1) no use of a prohibited treatment (corticosteroids after the eight week following inclusion, parenteral nutrition, other biological agents); (2) no endoscopic dilation; (3) no bowel surgery for resection of small bowel stricture; (4) no severe adverse events leading to ustekinumab withdrawal and (5) no study withdrawal whatever the reason. Clinical improvement was measured by symptoms and clinical remission (Crohn's Disease Activity Index \<150), steroid-free symptom improvement (obstructive symptom score) following initial steroid tapering, Crohn's Disease Obstructive Score (improvement of ≥1 point), treatment failure (defined as bowel obstruction requiring surgery, endoscopic balloon dilation, or persisting symptoms necessitating change in treatment), the need for surgery.

  up to 52 weeks

Secondary Outcomes (4)

• Number of participants with improvement in stricture inflammation and morphology on imaging

  at week 8, 24, 52 and 104

• Number of participants with improvement in general health

  at week 8, 24, 52 and 104

• Number of Participants with surgery

  at week 8, 24, 52 and 104

• Number of participants with treatment success at week 104

  at week 104

Other Outcomes (4)

• Degree of HBI reduction (Clinical response)

  at week 8, 24, 52 and 104

• Reduction in CRP and FC levels (Biochemical ease)

  at week 8, 24, 52 and 104

• UST drug concentration

  at week 8, 24, 52 and 104

Study Arms (1)

patients with symptomatic stricturing Crohn's disease

The decision to start ustekinumab was at the discretion of the treating physician. The initial intravenous (IV) infusion with ustekinumab at baseline was weight-adjusted (260 mg ≤55 kg, 390 mg between 55 and 85 kg, 520 mg ≥85 kg). According to the label, the first subcutaneous (SC) 90 mg induction dose was administered at week 8 followed by a maintenance dose of 90 mg SC every 8 or 12 weeks, at the discretion of the physician.

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

The initial intravenous (IV) infusion with ustekinumab at baseline was weight-adjusted (260 mg ≤55 kg, 390 mg between 55 and 85 kg, 520 mg ≥85 kg). According to the label, the first subcutaneous (SC) 90 mg induction dose was administered at week 8 followed by a maintenance dose of 90 mg SC every 8 or 12 weeks, at the discretion of the physician. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.

Also known as: Stelara

patients with symptomatic stricturing Crohn's disease

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants were adult CD patients treated with their first UST therapy for symptomatic strictures (confirmed on endoscopy or imaging) from centers of IBD at 8 hospitals all over China. This study does not involve the use of vulnerable groups.

You may qualify if:

• Clinical diagnosis of moderate to severe Crohn's disease
• Obstructive symptoms within the last eight weeks
• A single or several lumen stricture(s) identified by radiological imaging or endoscopy
• For strictures identified by CT enterograph defined as a lesion with combination of a reduction of luminal narrowing \>50%, an increase in bowel wall thickness \>25% relative to non-affected bowel and pre-stricture dilation \>3.0 cm
• For strictures identified during endoscopic procedure defined by intestinal strictures with a lumen diameter ≤12 mm or even inability to pass the endoscope across the narrowing

You may not qualify if:

• Requirement of urgent surgery or endoscopic intervention within 2 months as judged by the clinician
• Symptoms or signs of perforation such as active perianal sepsis, abdominal abscess, intestinal fistula, and abdominal adhesions
• Intestinal obstruction caused by surgery, intra-abdominal abscess, isolated intestinal stricture
• Effective treatments for stricture in the past half a year, such as endoscopic balloon dilatation, intestinal stricture plasty, surgery/manual anal dilatation, etc.
• Unable to eat after using enteral nutrition for more than 2 months
• History of ustekinumab (UST) or other IL-23 antagonists use in the past 12 months
• CT enterograph contraindications, such as allergy to contrast media
• Relative contraindications of biological agents, such as pulmonary tuberculosis-positive chest X-ray or active tuberculosis with strong positive tuberculin skin test, myocardial infarction, heart failure, or demyelinating neurological disease
• Currently suffering from a solid tumor, lymphoma, or melanoma and undergoing chemotherapy or radiation therapy
• Combination of intestinal dysplasia (eg, diagnosed with short bowel syndrome), colostomy, or colorectal tumors
• Combination of active gastrointestinal bleeding, shock, severe diarrhea, refractory vomiting and severe malabsorption syndrome
• Combination of severe liver and kidney dysfunction
• Coexistence of bacterial or viral active infection
• Pregnant or breastfeeding
• Severe hemodynamics, unstable vital signs or presence of rapidly progressive or end-stage disease, expected to be fatal during the course of the study

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Chongqing Renji Hospital, University of Chinese Academy of Sciences: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Seventh Medical Center of PLA Army General Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Yangzhou University: collaborator
• Xian-Janssen Pharmaceutical Ltd.: collaborator

Study Sites (8)

Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital

Beijing, Beijing Municipality, China

RECRUITING

Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences

Chongqing, Chongqing Municipality, China

RECRUITING

Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Department of Gastroenterology, Huai'an First People's Hospital

Huai'an, Jiangsu, China

RECRUITING

Department of Gastroenterology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

Department of Gastroenterology, Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

RECRUITING

Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

fixed tissue，blood

MeSH Terms

Conditions

Crohn Disease; Constriction, Pathologic

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yan Chen, MD.

  Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine

  STUDY CHAIR

• Jingwen Liu, MD.

  Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Chen, MD.

CONTACT

+86-571-87783777; chenyan72_72@zju.edu.cn

Jingwen Liu, MD.

CONTACT

+86-571-87767061; jingwen@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2025-12

Locations

CN (8)