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RECRUITING

NCT06408935

PHASE3

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

Sponsor: Janssen-Cilag Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2024-04-17

Completion Date

2028-03-06

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Crohn's Disease

Interventions

DRUG

Guselkumab

Guselkumab will be administered IV and SC.

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

Locations (84)

Center for Colitis and Crohns Disease University of California

San Francisco, California, United States

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

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

BSF Studiengesellschaft

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

Universitaetsklinikum Ulm

Ulm, Germany

Rambam Medical Center

Haifa, Israel

The Edith Wolfson Medical Center

Holon, Israel

Hadassah Medical Organization

Jerusalem, Israel

Galilee Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliera Policlinico S. Orsola-Malpighi

Bologna, Italy

ASST Fatebenefratelli Sacco

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Universita Di Napoli Federico Ii

Naples, Italy

ASL Toscana Nord Ovest PO Valdera Ospedale Lotti

Pontedera Pisa, Italy

Asst Rhodense - Ospedale Di Rho

Rho, Italy

Universita Campus Bio-Medico di Roma

Roma, Italy

Fondazione Policlinico Tor Vergata

Roma, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

Rozzano, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

NZOZ Centrum Medyczne KERmed

Bydgoszcz, Poland

Centrum Medyczne Medyk

Rzeszów, Poland

GASTROMED Sp. z o.o.

Torun, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Melita Medical Sp. z o.o.

Wroclaw, Poland

Centrum Medyczne Oporow

Wroclaw, Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, Poland

ETG Zamosc

Zamość, Poland

FNsP F.D.R. Banska Bystrica

Banská Bystrica, Slovakia

Cliniq s.r.o.

Bratislava, Slovakia

ENDOMED s.r.o

Košice, Slovakia

KM Management spol. s r.o.

Nitra, Slovakia

GASTRO I. s.r.o.

Prešov, Slovakia

Hosp. Gral. Univ. Dr. Balmis

Alicante, Spain

Hosp Reina Sofia

Córdoba, Spain

Complejo Hosp Univ. de Ferrol

Ferrol, Spain

Hosp. Univ. de La Paz

Ferrol, Spain

Hosp. Univ. de La Princesa

Madrid, Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Madrid, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Hosp. Alvaro Cunqueiro

Vigo, Spain

Chang-Hua Christian Hospital

Changhua, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (84)