A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease (CHARGE)

June 4, 2026 updated by: Janssen Research & Development, LLC

A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Recruiting
        • GIRI Gastrointestinal Research Institute
    • Ontario
      • London, Ontario, Canada, N6K 1M6
        • Recruiting
        • London Digestive Disease Institute
      • Oshawa, Ontario, Canada, L1J 0C7
        • Recruiting
        • Taunton Surgical Centre
      • Toronto, Ontario, Canada, M6A 3B4
        • Recruiting
        • Toronto Immune and Digestive Health Institute Inc
    • Quebec
      • Montreal, Quebec, Canada, H3H1E3
        • Recruiting
        • Clinique IMD
  • China
      • Guangzhou, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital Sun Yat sen University
  • Denmark
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Sydvestjysk Sygehus
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev Hospital
  • Sweden
      • Mölndal, Sweden, 431 30
        • Recruiting
        • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset
      • Stockholm, Sweden, 116 30
        • Recruiting
        • Ersta sjukhus
  • United Kingdom
      • Greater London, United Kingdom, E1 2AJ
        • Recruiting
        • Barts Health NHS Trust
      • Greater London, United Kingdom, NW10 7NS
        • Recruiting
        • London North West University Healthcare NHS Trust
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Recruiting
        • Digestive Health Specialists of the Southeast
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinnova Research
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • United Gastroenterologists
      • Los Angeles, California, United States, 90048
        • Recruiting
        • TLC Clinical Research Inc
      • Newport Beach, California, United States, 92663
        • Suspended
        • Hoag Memorial Hospital
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Peak Gastroenterology Associates
    • Florida
      • Miami, Florida, United States, 33157-6575
        • Recruiting
        • Sanchez Clinical Research, Inc
      • Tampa, Florida, United States, 33609
        • Recruiting
        • GCP Clinical Research
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton-O'Neil Clinical Research Center
    • New York
      • Carmel, New York, United States, 10512
        • Recruiting
        • Westchester Putnam Gastroenterology
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Charlotte Gastroenterology and Hepatology, PLLC
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • Great Lakes Gastroenterology Research, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73114
        • Recruiting
        • Digestive Disease Specialists Inc
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Recruiting
        • Frontier Clinical Research
    • South Carolina
      • Summerville, South Carolina, United States, 29486
        • Recruiting
        • Palmetto Primary and Specialty Care Physicians, Charleston
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
  • Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 but less than or equal to (<=) 450

  • Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) >= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:

    1. a minimum score of 1 for the component of "size of ulcers" AND
    2. a minimum score of 1 for the component of "ulcerated surface"
  • In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
  • Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol

Exclusion criteria

  • Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
  • Currently has or is suspected to have an abscess
  • Has an active fistula during screening or at Week 0 with an anticipated need for surgery
  • Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
  • Currently has a malignancy or has a history of malignancy within 5 years before screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Guselkumab
Participants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
Drug: Guselkumab
Guselkumab will be administered.
Other Names:
  • CNTO1959
Experimental: Risankizumab
Participants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.
Drug: Risankizumab
Risankizumab will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Deep Remission at Week 52
Time Frame: At Week 52
Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (<) 150-point. CDAI will be assessed by collecting information on 8 different CD-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 activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
At Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52
Time Frame: At Week 52
Clinical remission is defined as CDAI score < 150-point. CDAI will be assessed by collecting information on 8 different CD-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 activity. Endoscopic response is defined as >50 percent (%) improvement from baseline in the SES CD or SES-CD score <= 2 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response.
At Week 52
Number of Participants with Endoscopic Remission at Week 52
Time Frame: At Week 52
Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score > 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.
At Week 52
Number of Participants with Clinical Remission at Week 52
Time Frame: At Week 52
Clinical remission is defined as CDAI score < 150-point. CDAI will be assessed by collecting information on 8 different CD-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 activity.
At Week 52
Number of Participants with Steroid-Free Clinical Remission at Week 52
Time Frame: At Week 52
Steroid-free clinical remission is defined as clinical remission at Week 52 and not receiving corticosteroids for at least 90 days prior to Week 52. Clinical remission is defined as CDAI score < 150-point.
At Week 52
Number of Participants with Abnormalities in Laboratory Parameters
Time Frame: Up to Week 148
Number of participants with abnormalities in laboratory parameters (hematology and chemistry) will be reported.
Up to Week 148
Number of Participants With Change From Baseline in Laboratory Abnormalities
Time Frame: Up to week 148
Number of participants with change from baseline in laboratory abnormalities (hematology and chemistry) will be reported.
Up to week 148
Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention
Time Frame: Up to Week 165
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Up to Week 165

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNTO1959CRD3009 (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 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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