🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06408935
Active, not recruiting Phase 3

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

NCT06408935 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen-Cilag Ltd.
Phase
Phase 3
Started
2024-04-17
Last updated
2026-08-28

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

Guselkumab →

Guselkumab: Guselkumab will be administered IV and SC.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (84)

FacilityCityRegionStatus
Center for Colitis and Crohns Disease University of California San Francisco California
The University of Chicago Medical Center (UCMC) Chicago Illinois
Washington University School Of Medicine St Louis Missouri
Medical University of South Carolina Charleston South Carolina
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
Western University & London Health Sciences Centre London Ontario
Hopital du Sacre-Coeur de Montreal Montreal Quebec
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
Aphm - Hopital Nord Marseille France
CHU de Nantes hotel Dieu Nantes France
APHP - Hopital Bichat - Claude Bernard Paris France
Klinikum Augsburg Augsburg Germany
Charite Universitaetsmedizin Berlin Berlin Germany
Praxis Fur Gastroenteroligie Berlin Germany
Medizinisches Versorgungszentrum (MVZ) Dachau Dachau Germany
Universitatsklinikum Frankfurt/ Medizinische Klinik 1 Frankfurt Germany
Universitatsmedizin Gottingen Göttingen Germany
Studiengesellschaft Mitteldeutschland GmbH Halle Germany
Medizinische Hochschule Hannover Hanover Germany
Universitatsklinikum Schleswig Holstein Kiel Germany
Staedtisches Klinikum Lueneburg Lüneburg Germany
MVZ Portal 10 Münster Germany
Siloah St Trudpert Klinikum Pforzheim Germany

+ 44 more sites — see the full list on the official registry below.

On this site

📄 Tremfya (guselkumab) drug profile →

More Janssen-Cilag Ltd. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06408935 on ClinicalTrials.gov ↗ ← All trials in the USA