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Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
NCT06408935 · Janssen-Cilag Ltd.
In plain English
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Official title
A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients
About this study
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 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
Study design
Enrollment target: 112 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-04-17
Estimated completion: 2028-03-06
Last updated: 2026-04-13
Interventions
Drug: Guselkumab
Primary outcomes
- • Percentage of Participants Achieving a Magnetic Resonance Index of Activity (MaRIA) Less Than (<)11 in All Intestinal Segments at Week 48 (At Week 48)
Sponsor
Janssen-Cilag Ltd. · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Cilag Ltd. Clinical trial · study_director, Janssen-Cilag Ltd.
All locations (84)
Center for Colitis and Crohns Disease University of CaliforniaRecruiting
San Francisco, California, United States
The University of Chicago Medical Center (UCMC)Completed
Chicago, Illinois, United States
Washington University School Of MedicineCompleted
St Louis, Missouri, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
The Queen Elizabeth HospitalRecruiting
Adelaide, Australia
Concord Repatriation General HospitalRecruiting
Concord, Australia
Northern HospitalRecruiting
Melbourne, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Australia
Mater Hospital BrisbaneRecruiting
South Brisbane, Australia
AZ Maria MiddelaresRecruiting
Ghent, Belgium
CHU de LiegeRecruiting
Liège, Belgium
VitazCompleted
Sint-Niklaas, Belgium
CligedRecruiting
Macaé, Brazil
Instituto Mederi de Pesquisa e SaudeRecruiting
Passo Fundo, Brazil
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do SulRecruiting
Porto Alegre, Brazil
INTEGRAL Pesquisa e EnsinoRecruiting
Votuporanga, Brazil
Foothills HospitalCompleted
Calgary, Alberta, Canada
Western University & London Health Sciences CentreRecruiting
London, Ontario, Canada
Hopital du Sacre-Coeur de MontrealRecruiting
Montreal, Quebec, Canada
Nemocnice Ceske Budejovice a sRecruiting
České Budějovice, Czechia
Hepato-gastroenterologie HK, s.r.o.Completed
Hradec Králové, Czechia
ISCARE a.s.Recruiting
Prague, Czechia
CHU Amiens PicardieRecruiting
Amiens, France
CHU de Clermont FerrandRecruiting
Clermont-Ferrand, France
CHRU de Lille Hopital Claude HuriezRecruiting
Lille, France
Aphm - Hopital NordRecruiting
Marseille, France
CHU de Nantes hotel DieuRecruiting
Nantes, France
APHP - Hopital Bichat - Claude BernardRecruiting
Paris, France
Klinikum AugsburgRecruiting
Augsburg, Germany
Charite Universitaetsmedizin BerlinRecruiting
Berlin, Germany
Praxis Fur GastroenteroligieRecruiting
Berlin, Germany
Medizinisches Versorgungszentrum (MVZ) DachauRecruiting
Dachau, Germany
Universitatsklinikum Frankfurt/ Medizinische Klinik 1Completed
Frankfurt, Germany
Universitatsmedizin GottingenCompleted
Göttingen, Germany
BSF StudiengesellschaftCompleted
Halle, Germany
Medizinische Hochschule HannoverRecruiting
Hanover, Germany
Universitatsklinikum Schleswig HolsteinCompleted
Kiel, Germany
Staedtisches Klinikum LueneburgRecruiting
Lüneburg, Germany
MVZ Portal 10Completed
Münster, Germany
Siloah St Trudpert KlinikumRecruiting
Pforzheim, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Rambam Medical CenterRecruiting
Haifa, Israel
The Edith Wolfson Medical CenterRecruiting
Holon, Israel
Hadassah Medical OrganizationRecruiting
Jerusalem, Israel
Galilee Medical CenterRecruiting
Nahariya, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
The Chaim Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Azienda Ospedaliera Policlinico S. Orsola-MalpighiCompleted
Bologna, Italy
ASST Fatebenefratelli SaccoRecruiting
Milan, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Italy
Universita Di Napoli Federico IiCompleted
Naples, Italy
ASL Toscana Nord Ovest PO Valdera Ospedale LottiCompleted
Pontedera Pisa, Italy
Asst Rhodense - Ospedale Di RhoCompleted
Rho, Italy
Universita Campus Bio-Medico di RomaRecruiting
Roma, Italy
Fondazione Policlinico Tor VergataCompleted
Roma, Italy
Fondazione Policlinico Universitario A Gemelli IRCCSRecruiting
Roma, Italy
IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche IntestinaliRecruiting
Rozzano, Italy
IRCCS Ospedale Casa Sollievo della SofferenzaCompleted
San Giovanni Rotondo, Italy
NZOZ Centrum Medyczne KERmedRecruiting
Bydgoszcz, Poland
Centrum Medyczne MedykRecruiting
Rzeszów, Poland
GASTROMED Sp. z o.o.Recruiting
Torun, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Melita Medical Sp. z o.o.Completed
Wroclaw, Poland
Centrum Medyczne OporowRecruiting
Wroclaw, Poland
EuroMediCare Szpital Specjalistyczny z PrzychodniaRecruiting
Wroclaw, Poland
ETG ZamoscRecruiting
Zamość, Poland
FNsP F.D.R. Banska BystricaCompleted
Banská Bystrica, Slovakia
Cliniq s.r.o.Completed
Bratislava, Slovakia
ENDOMED s.r.oRecruiting
Košice, Slovakia
KM Management spol. s r.o.Completed
Nitra, Slovakia
GASTRO I. s.r.o.Recruiting
Prešov, Slovakia
Hosp. Gral. Univ. Dr. BalmisRecruiting
Alicante, Spain
Hosp Reina SofiaCompleted
Córdoba, Spain
Complejo Hosp Univ. de FerrolRecruiting
Ferrol, Spain
Hosp. Univ. de La PazCompleted
Ferrol, Spain
Hosp. Univ. de La PrincesaCompleted
Madrid, Spain
Hosp. Univ. Pta. de Hierro MajadahondaCompleted
Madrid, Spain
Hosp. Clinico Univ. de ValenciaRecruiting
Valencia, Spain
Hosp. Alvaro CunqueiroRecruiting
Vigo, Spain
Chang-Hua Christian HospitalRecruiting
Changhua, Taiwan
Far Eastern Memorial HospitalCompleted
New Taipei City, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan