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NCT Number: NCT07310095

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital Sun Yat sen University, Guangzhou, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guselkumab (GUS)

Drug

Guselkumab will be administered intravenously or by subcutaneous injection.

Other names: TREMFYA

Primary outcomes

  1. Percentage of Participants Achieving Clinical Remission At Week 48

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24

    Time frame: 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.

  3. Percentage of Participants Achieving Endoscopic Response

    Time frame: At Weeks 24 and 48

    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.

  4. Percentage of Participants Achieving Endoscopic Remission

    Time frame: At Weeks 24 and 48

    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.

  5. Baseline Characteristics of Participants With Endoscopic Remission: Age

    Time frame: Baseline

    Baseline characteristics of participants (age) with endoscopic remission will be reported.

  6. Baseline Characteristics of Participants With Endoscopic Remission: Sex

    Time frame: Baseline

    Baseline characteristics of participants (sex) with endoscopic remission will be reported.

  7. Baseline Characteristics of Participants With Endoscopic Remission: Height

    Time frame: Baseline

    Baseline characteristics of participants (height) with endoscopic remission will be reported.

  8. Baseline Characteristics of Participants With Endoscopic Remission: Weight

    Time frame: Baseline

    Baseline characteristics of participants (weight) with endoscopic remission will be reported.

  9. Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications

    Time frame: Baseline

    Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported.

  10. Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities

    Time frame: Baseline

    Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported.

  11. Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures

    Time frame: Baseline

    Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Xian-Janssen Pharmaceutical Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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