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

ConditionCrohn Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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).

Eligibility criteria

Qualifiers

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

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

a minimum score of 1 for the component of "ulcerated surface"

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Guselkumab
  • Risankizumab

Treatment groups

530 Participants
are divided into 2 treatment groups