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Guselkumab treatment for healing Crohn's disease

A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients

Phase 3 Interventional Janssen-Cilag Ltd. · NCT06408935

This study is testing if the medication guselkumab can help heal all layers of the digestive tract in people with Crohn's disease who haven't had enough relief from other treatments.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment112 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen-Cilag Ltd. Industry-sponsored
Drugs / interventionsinfliximab, adalimumab, certolizumab, vedolizumab, ustekinumab, guselkumab
Locations65 sites (Adelaide and 64 other locations)
Trial IDNCT06408935 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of guselkumab in achieving transmural healing in patients with Crohn's disease. It utilizes the Magnetic Resonance Index of Activity (MaRIA) score to assess healing across all layers of the digestive tract over a 48-week period. Patients with clinically active Crohn's disease who have not responded adequately to conventional therapies will be enrolled. The study aims to provide insights into the disease-modifying effects of guselkumab.

Who should consider this trial

Good fit: Ideal candidates are adults with luminal Crohn's disease who have active symptoms and have not responded well to standard treatments.

Not a fit: Patients with mild Crohn's disease or those who have not yet tried conventional therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing and management of Crohn's disease for patients.

How similar studies have performed: Other studies have shown promising results with similar biologic therapies for Crohn's disease, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Has luminal Crohn's disease (CD) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
* Has clinically active CD, defined as a baseline CD activity index (CDAI) score greater 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 or very soft stools or b. Mean daily AP score \>=2, based on the unweighted CDAI component of abdominal pain (AP)
* Active transmural activity in at least one segment (segmental magnetic resonance index of activity \[MaRIA\] \>= 11)
* a. Has demonstrated inadequate response/intolerance to conventional therapy; b. Has previously 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 advanced therapies at a dose approved for the treatment of Crohn's disease (that is, janus kinase \[JAK\] 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 displaying associated fistula/fistulae and/or or abscess), fibrotic stenosis, internal fistulas, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, 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
* Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active perianal fistulas may be included if there are no associated stenoses, no anticipated surgery and no abscesses currently identified
* Has had any kind of bowel resection within 6 months, or any other intra-abdominal or other 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, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, in the previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen

Where this trial is running

Adelaide and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.