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NCT Number: NCT07499232

A Study of Guselkumab Versus Risankizumab in 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medizinische Universitatsklinik Innsbruck, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

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

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:
  • a minimum score of 1 for the component of "size of ulcers" AND
  • 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

Treatment and study plan

Guselkumab

Drug

Guselkumab will be administered.

Other names: CNTO1959

Risankizumab

Drug

Risankizumab will be administered.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

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

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: CHARGE

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Mar 30, 2026
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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