Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Inclusion Criteria:

• Has luminal Crohn's disease (CD) of at least 3 months duration (defined as a minimumof 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in thepast by radiography, histology, and/or endoscopy

• Has clinically active CD, defined as a baseline CD activity index (CDAI) scoregreater than or equal to (>=)220 but <=450 and either: a. Mean daily stool frequency (SF) count >=4, based on the unweighted CDAI component of the number of liquid orvery soft stools or b. Mean daily AP score >=2, based on the unweighted CDAIcomponent of abdominal pain (AP)

• Active transmural activity in at least one segment (segmental magnetic resonanceindex of activity [MaRIA] >= 11)

• a. Has demonstrated inadequate response/intolerance to conventional therapy; b. Haspreviously demonstrated lack of initial response (that is, primary non-responders),responded initially but then lost response with continued therapy (that is,secondary non-responders), or was intolerant to a maximum of 1 class of advancedtherapies at a dose approved for the treatment of Crohn's disease (that is, januskinase [JAK] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab,ustekinumab, or approved biosimilars for these agents)

Exclusion Criteria:

• Has complications of Crohn's disease, such as symptomatic strictures or stenoses (unless less than [<]3 centimeter (cm) dilatation and not symptomatic or displayingassociated fistula/fistulae and/or or abscess), fibrotic stenosis, internalfistulas, short gut syndrome, or any other manifestation, that might be anticipatedto require surgery, could preclude the use of the CDAI to assess response totherapy, or would possibly confound the ability to assess the effect of treatmentwith guselkumab

• Currently has or is suspected to have an abscess. Recent cutaneous and perianalabscesses are not exclusionary if drained and adequately treated at least 3 weeksbefore baseline, or 8 weeks before baseline for intra-abdominal abscesses, providedthat there is no anticipated need for any further surgery. Participants with activeperianal fistulas may be included if there are no associated stenoses, noanticipated surgery and no abscesses currently identified

• Has had any kind of bowel resection within 6 months, or any other intra-abdominal orother major surgery within 12 weeks before baseline

• Has a draining (that is, functioning) stoma or ostomy

• Has a stool culture or other examination positive for an enteric pathogen, includingClostridioides difficile (formerly known as Clostridium difficile) toxin, in theprevious 4 months, unless a repeat examination is negative and there are no signs ofongoing infection with that pathogen