A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)

Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab

The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: Guselkumab (GUS)

• Study Type: Interventional
• Enrollment (Estimated): 78
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• China
  • Guangzhou, China, 510655
    • Recruiting
    • The Sixth Affiliated Hospital Sun Yat sen University
  • Guangzhou, China, 510060
    • Recruiting
    • The First Affiliated Hospital Sun Yat sen University
  • Hangzhou, China, 310018
    • Recruiting
    • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
  • Hefei, China, 230022
    • Recruiting
    • The First Affiliated Hospital of Anhui Medical University
  • Shanghai, China, 200031
    • Recruiting
    • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Has a confirmed diagnosis of Crohn's disease (CD)
• Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 and either mean daily stool frequency (SF) count >= 4 or mean daily abdominal pain (AP) score >=2
• Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram [mg]/kilogram [kg] intravenous [IV] followed by 90 mg subcutaneous [SC] at week 8) as the instruction manual
• Initially responded to UST induction therapy and then lose response to UST
• During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic

Exclusion Criteria:

• Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)
• Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
• Is currently enrolled in an interventional clinical study
• Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
• Have a current or be suspected to have an abscess

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guselkumab Treatment; Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy.	Drug: Guselkumab (GUS); Guselkumab will be administered intravenously or by subcutaneous injection.; Other Names: TREMFYA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Remission At Week 48	Clinical remission is defined as less than (<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.	At Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48	Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.	At Weeks 12, 24 and 48
Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24	Clinical remission is defined as < 150-point reduction in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.	At Weeks 12 and 24
Percentage of Participants Achieving Endoscopic Response	Endoscopic response is defined as >= 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease.	At Weeks 24 and 48
Percentage of Participants Achieving Endoscopic Remission	Endoscopic remission is defined as SES-CD less than or equal to (<=) 2 in any individual component. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease.	At Weeks 24 and 48
Baseline Characteristics of Participants With Endoscopic Remission: Age	Baseline characteristics of participants (age) with endoscopic remission will be reported.	Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Sex	Baseline characteristics of participants (sex) with endoscopic remission will be reported.	Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Height	Baseline characteristics of participants (height) with endoscopic remission will be reported.	Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Weight	Baseline characteristics of participants (weight) with endoscopic remission will be reported.	Baseline
Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications	Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported.	Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities	Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported.	Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures	Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported.	Baseline

Collaborators and Investigators

• Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Investigators: Study Director: Xi'an Janssen Pharmaceutical Clinical Trial, Xi'an Janssen Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; guselkumab
• Other Study ID Numbers: CNTO1959CRD4007 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No