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

Running, not enrolling · Phase 3

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

Key facts

Study ID: NCT06408935
Run by: Janssen-Cilag Ltd.
People needed: 120
Starts: 2024-04-17
Expected to finish: 2028-03-06
Last updated by the study team: 2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 it is running

The University of Chicago Medical Center (UCMC) — Chicago, Illinois, United States
Washington University School Of Medicine — St Louis, Missouri, United States
Medical University of South Carolina — Charleston, South Carolina, United States
The Queen Elizabeth Hospital — Adelaide, Australia
Concord Repatriation General Hospital — Concord, Australia
Northern Hospital — Melbourne, Australia
Fiona Stanley Hospital — Murdoch, Australia
Mater Hospital Brisbane — South Brisbane, Australia
AZ Maria Middelares — Ghent, Belgium
CHU de Liege — Liège, Belgium
Vitaz — Sint-Niklaas, Belgium
Cliged — Macaé, Brazil
Instituto Mederi de Pesquisa e Saude — Passo Fundo, Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul — Porto Alegre, Brazil
INTEGRAL Pesquisa e Ensino — Votuporanga, Brazil
Foothills Hospital — Calgary, Alberta, Canada
Western University & London Health Sciences Centre — London, Ontario, Canada
Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada
Nemocnice Ceske Budejovice a s — České Budějovice, Czechia
Hepato-gastroenterologie HK, s.r.o. — Hradec Králové, Czechia
ISCARE a.s. — Prague, Czechia
CHU Amiens Picardie — Amiens, France
CHU de Clermont Ferrand — Clermont-Ferrand, France
CHRU de Lille Hopital Claude Huriez — Lille, France
Center for Colitis and Crohns Disease University of California — San Francisco, California, United States

Full record on ClinicalTrials.gov

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