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

NCT07310095 | Recruiting Phase 4

• 1 other identifier: CNTO1959CRD4007
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48

  At Weeks 12, 24 and 48

• Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24

  At Weeks 12 and 24

• Percentage of Participants Achieving Endoscopic Response

  At Weeks 24 and 48

• Percentage of Participants Achieving Endoscopic Remission

  At Weeks 24 and 48

• Baseline Characteristics of Participants With Endoscopic Remission: Age

  Baseline

Study Arms (1)

Guselkumab Treatment

EXPERIMENTAL

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)

Interventions

Guselkumab (GUS) DRUG

Guselkumab will be administered intravenously or by subcutaneous injection.

Also known as: TREMFYA

Guselkumab Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (5)

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510060, China

RECRUITING

The Sixth Affiliated Hospital Sun Yat sen University

Guangzhou, 510655, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310018, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

RECRUITING

Ruijin Hospital

Shanghai, 200031, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Xi'an Janssen Pharmaceutical Clinical Trial

  Xi'an Janssen Pharmaceutical

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (5)