A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis (GENIUS)

Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study

The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon [part of large intestine] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.

Study Overview

• Status: Recruiting
• Conditions: Colitis, Ulcerative

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

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

Study Locations

• China
  • Beijing, China, 100044
    • Recruiting
    • Peking University People's Hospital
  • Beijing, China, 100006
    • Recruiting
    • Peking Union Medical College Hospital
  • Changzhou, China, 213003
    • Recruiting
    • Changzhou No 2 Peoples Hospital
  • Guangzhou, China, 510080
    • Recruiting
    • The First Affiliated Hospital Sun Yat-Sen University
  • Guangzhou, China
    • Recruiting
    • The Sixth Affiliated Hospital of Sun Yat-sen University
  • Hangzhou, China, 310009
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University
  • Nanjing, China, 223800
    • Recruiting
    • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • Shijiazhuang, China, 050000
    • Recruiting
    • The Second Hospital of Hebei Medical University
  • Tianjin, China, 300052
    • Recruiting
    • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Eligible Chinese participants with moderate-to-severe UC who are bio-naive will be consecutively enrolled in this study.

Description

Inclusion criteria:

• Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (>=) 2; c) Mayo rectal bleeding subscore (RBS) >= 1 at baseline
• Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
• Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment
• Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion criteria:

• Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy
• Contraindicated to guselkumab per the label
• Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab
• Participants who will be receiving guselkumab therapy combined with a second advanced therapy
• Participants with a history of colectomy and/or pouch

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Guselkumab: Moderate to Severe Ulcerative Colitis (UC); Participants with confirmed diagnosis of moderate-to-severe UC treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected and observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Response at Week 12	Clinical response is defined as a decrease from baseline in the partial Mayo score by >= 30 percent (%) and >= 2 points, with either a >=1 decrease from baseline in rectal bleeding subscore (RBS) or an RBS of 0 or 1. Partial Mayo score is a non-invasive clinical measure for determining the severity of UC. The total score falls between 0 and 9, where higher score indicates more severity.	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Clinical Response at Week 24 and Week 48	Clinical response is defined as a decrease from baseline in the partial Mayo score by >= 30 % and >= 2 points, with either a >=1 decrease from baseline in RBS or an RBS of 0 or 1. Partial Mayo score is a non-invasive clinical measure for determining the severity of UC. The total score falls between 0 and 9, where higher score indicates more severity.	At Week 24 and Week 48
Percentage of Participants Achieving Symptomatic Response at Week 2	Symptomatic response is defined as a decrease from induction baseline in the patient reported outcome (PRO)-2 by at least 30% and at least 1 point, with either at least 1-point decrease from induction baseline in RBS or an RBS of 0 or 1. PRO-2 consists of the two components (rectal bleeding and stool frequency). The stool frequency subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The rectal bleeding subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). Higher score indicates more severity in symptoms.	At Week 2
Mean Change from Baseline in Stool Frequency Subscore (SFS) Over Week 2	SFS is a component of PRO-2. The stool frequency subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). Higher score indicates more severity in symptoms.	From Baseline to Week 2
Mean Change from Baseline in RBS Over Week 2	RBS is a component of PRO-2. The rectal bleeding subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). Higher score indicates more severity in symptoms.	From Baseline to Week 2
Percentage of Participants Achieving Clinical Remission at Week 12, Week 24 and Week 48	Clinical remission is defined as a partial Mayo score less than or equal to (<=) 2 with no sub-score greater than (>) 1. Partial Mayo score is a non-invasive clinical measure for determining the severity of UC. The total score falls between 0 and 9, where higher score indicates more severity.	At Week 12, Week 24 and Week 48
Percentage of Participants Achieving Symptomatic Remission at Week 2	Symptomatic remission as measured by PRO-2 is defined as a SFS of 0 or 1 and an RBS of 0, where the SFS has not increased from induction baseline. The SFS is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RBS is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). Higher score indicates more severity in symptoms.	At Week 2
Percentage of Participants Achieving Steroid-Free Remission at Week 12, 24 and 48	Steroid-free remission is defined as clinical remission with no use of corticosteroids for at least 30 days. Clinical remission is defined as partial Mayo score <= 2 with no sub-score >1.	At Weeks 12, 24 and 48
Percentage of Participants Achieving Sustained Remission at Week 24 and Week 48	Sustained remission is defined as clinical remission maintenance status at post-induction (Week 12) in participants who had attained clinical remission by the end of the 12-week induction therapy.	At Week 24 and Week 48
Percentage of Participants with Endoscopic Improvement (Healing) at Week 24 and Week 48	Endoscopic improvement (healing) is defined as endoscopic remission Mayo endoscopic subscore (MES) of 0 or 1. The MES consists of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each subscore is graded from 0 (normal) to 3 (severe) with higher scores indicate more severe disease.	At Week 24 and Week 48
Percentage of Participants Achieving Endoscopic Remission (Normalization) at Week 24 and Week 48	Endoscopic remission (normalization) is defined as an MES of 0. The MES consists of 3 subscores: stool frequency, rectal bleeding and physician's global assessment, each subscore is graded from 0 (normal) to 3 (severe) where higher scores indicate more severe disease.	At Week 24 and Week 48
Percentage of Participants Discontinuing from Treatment	Treatment discontinuation is defined as discontinuation of guselkumab treatment for any reason.	Up to Week 48
Percentage of Participants Switching from Treatment	Treatment switch is defined as initiation of another medication for UC treatment after guselkumab discontinuation.	Up to Week 48
Time to Treatment Discontinuation	Time to treatment discontinuation is defined as the time from the guselkumab start date to the time of treatment discontinuation.	Up to Week 48
Time to Treatment Switch	Time to treatment switch is defined as the time from the guselkumab start date to the time of initiation of a new treatment other than guselkumab.	Up to Week 48
Percentage of Participants on Guselkumab Dosing Schedules of 200 Milligrams (mg) Once Every 4 Weeks (q4w) or 100 mg Once Every 8 Weeks (q8w)	The percentage of participants on guselkumab dosing schedules of 200mg q4w or 100 mg q8w will be assessed. For each dosing schedule, the percentage will be calculated by dividing the number of participants receiving the specific dosing regimen by the number of participants still being followed up at those time points, multiplied by 100%.	From Baseline through Week 12 to Week 48
Percentage of Participants Undergoing Dose Escalation/ De-Escalation	Percentage of participants having dose escalation/ de-escalation during maintenance treatment will be assessed. The percentage will be calculated by dividing the number of participants having dosage adjustment (that is, dose escalation/de-escalation) after Week 0 at any visit time point compared to his/her previous recorded administration dosage, multiplied by 100%.	Week 12 up to Week 48
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission	IBDQ remission is defined as total IBDQ score >= 170. The IBDQ is a validated, 32-item, self-reported questionnaire for patients with inflammatory bowel disease that will be used to evaluate the disease-specific health-related quality of life (QoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic functions (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.	At Week 12, Week 24 and Week 48
Change from Baseline in C-Reactive Protein (CRP) Levels	Change in CRP levels since guselkumab initiation will be reported.	Baseline, Week 12, Week 24 and Week 48
Change from Baseline of Fecal Calprotectin Levels	Change in fecal calprotectin levels since guselkumab initiation will be reported.	Baseline, Week 12, Week 24 and Week 48
Percentage of Participants Achieving CRP Normalization	Normalization of CRP is defined as reduction of less than or equal to 5 microgram per liter (mg/L) at weeks 12, 24 and 48 since baseline. Percentage of participants with abnormal CRP at baseline achieving CRP normalization will be reported.	At Week 12, Week 24 and Week 48
Percentage of Participants Achieving Fecal Calprotectin (FCP) Normalization	Normalization of fecal calprotectin is defined as reduction of <= 250 microgram per gram (mcg/g) at weeks 12, 24 and 48 since baseline. Percentage of participants with abnormal FCP at baseline achieving fecal calprotectin normalization will be reported.	At Week 12, Week 24 and Week 48

Collaborators and Investigators

• Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Investigators: Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Xian-Janssen Pharmaceutical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: CNTO1959UCO4003 (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 www.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.