RecruitingPhase 3NCT06408935

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

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

Sponsor

Janssen-Cilag Ltd.

Enrollment

112 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Crohn's Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests guselkumab (an injectable biologic medication targeting inflammation) for active Crohn's disease. The study specifically looks at whether guselkumab can achieve "transmural healing" — meaning healing that goes all the way through the intestinal wall, not just the inner surface. **You may be eligible if...** - You have had Crohn's disease for at least 3 months affecting the colon, small intestine, or both - Your Crohn's disease is currently active (moderate to severe symptoms) - You have at least 4 loose stools per day on average, or significant abdominal pain **You may NOT be eligible if...** - You have a complication such as an abscess or fistula that requires immediate surgery - You have an active serious infection - You have previously failed or are intolerant to certain biologic medications - You have significant other health conditions that would make the study treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGuselkumab

Guselkumab will be administered IV and SC.

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

View Full Details on ClinicalTrials.gov

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NCT06408935

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