RightFit
RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares how well guselkumab and risankizumab work for people with moderate to severe Crohn’s disease. Crohn’s disease is a long-term illness that causes swelling and damage in the digestive tract.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have had Crohn’s disease for at least 12 weeks, confirmed by scans, tissue tests, or a scope exam. It must affect the small bowel, large bowel, or both.
  • Your Crohn’s disease is moderate to severe, with a disease activity score (CDAI) of 220 to 450.
  • A screening scope exam shows active disease and ulcers. The scope score must be at least 4 for disease only in the small bowel, or at least 6 if the large bowel is affected. Both ulcer size and the area covered by ulcers must score at least 1.
  • The study doctor thinks the study’s ongoing treatment doses are right for your disease.
  • You can follow the study’s rules for other Crohn’s disease medicines.

Who can't join

  • You have Crohn’s complications that may need surgery within a year or make treatment results hard to measure. These may include narrowed bowel, too little working bowel, an actively draining bowel opening, or serious fistulas (abnormal tunnels between body parts).
  • You have, or may have, an abscess (a pocket of pus).
  • You have an active fistula during screening or at Week 0 that is expected to need surgery.
  • You had part of your bowel removed within 24 weeks before the first study dose, or other major surgery within 12 weeks before that dose.
  • You have cancer now or had cancer within 5 years before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (39)

AL

CA

CO

CT

FL

GA

IA

KS

LA

MA

MD

MI

NC

NY

OH

OK

PA

SC

TX