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

Status: Recruiting
Location: See all (80) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
Center for Colitis and Crohns Disease University of California
RECRUITING
San Francisco
Missouri
Washington University School Of Medicine
RECRUITING
St Louis
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Other Locations
Australia
The Queen Elizabeth Hospital
RECRUITING
Adelaide
Concord Repatriation General Hospital
RECRUITING
Concord
Northern Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Mater Hospital Brisbane
RECRUITING
South Brisbane
Belgium
AZ Maria Middelares
RECRUITING
Ghent
CHU de Liege
RECRUITING
Liège
Vitaz
RECRUITING
Sint-niklaas
Brazil
Cliged
RECRUITING
Macaé
Instituto Mederi de Pesquisa e Saude
RECRUITING
Passo Fundo
NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul
RECRUITING
Porto Alegre
INTEGRAL Pesquisa e Ensino
RECRUITING
Votuporanga
Canada
Foothills Hospital
RECRUITING
Calgary
Western University & London Health Sciences Centre
RECRUITING
London
Hopital du Sacre-Coeur de Montreal
RECRUITING
Montreal
France
CHU Amiens Picardie
RECRUITING
Amiens
CHU de Clermont Ferrand
RECRUITING
Clermont-ferrand
CHRU de Lille Hopital Claude Huriez
RECRUITING
Lille
Aphm - Hopital Nord
RECRUITING
Marseille
CHU de Nantes hotel Dieu
RECRUITING
Nantes
APHP - Hopital Bichat - Claude Bernard
RECRUITING
Paris
Germany
Klinikum Augsburg
RECRUITING
Augsburg
Charite Universitaetsmedizin Berlin
RECRUITING
Berlin
Praxis Fur Gastroenteroligie
RECRUITING
Berlin
Medizinisches Versorgungszentrum (MVZ) Dachau
RECRUITING
Dachau
Universitatsklinikum Frankfurt/ Medizinische Klinik 1
RECRUITING
Frankfurt
Universitatsmedizin Gottingen
RECRUITING
Göttingen
BSF Studiengesellschaft
RECRUITING
Halle
Medizinische Hochschule Hannover
RECRUITING
Hanover
Universitatsklinikum Schleswig Holstein
RECRUITING
Kiel
Staedtisches Klinikum Lueneburg
RECRUITING
Lüneburg
MVZ Portal 10
RECRUITING
Münster
Siloah St Trudpert Klinikum
RECRUITING
Pforzheim
Universitaetsklinikum Ulm
RECRUITING
Ulm
Israel
Rambam Medical Center
RECRUITING
Haifa
The Edith Wolfson Medical Center
RECRUITING
Holon
Hadassah Medical Organization
RECRUITING
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
RECRUITING
Bologna
ASST Fatebenefratelli Sacco
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Universita Di Napoli Federico Ii
RECRUITING
Napoli
ASL Toscana Nord Ovest PO Valdera Ospedale Lotti
RECRUITING
Pontedera Pisa
Asst Rhodense - Ospedale Di Rho
RECRUITING
Rho
Fondazione Policlinico Tor Vergata
RECRUITING
Roma
Fondazione Policlinico Universitario A Gemelli IRCCS
RECRUITING
Roma
Universita Campus Bio-Medico di Roma
RECRUITING
Roma
IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali
RECRUITING
Rozzano
IRCCS Ospedale Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
Poland
NZOZ Centrum Medyczne KERmed
RECRUITING
Bydgoszcz
Centrum Medyczne Medyk
RECRUITING
Rzeszów
GASTROMED Sp. z o.o.
RECRUITING
Torun
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
EuroMediCare Szpital Specjalistyczny z Przychodnia
RECRUITING
Wroclaw
Melita Medical Sp. z o.o.
RECRUITING
Wroclaw
ETG Zamosc
RECRUITING
Zamość
Slovakia
FNsP F.D.R. Banska Bystrica
RECRUITING
Banská Bystrica
Cliniq s.r.o.
RECRUITING
Bratislava
ENDOMED s.r.o
RECRUITING
Košice
KM Management spol. s r.o.
RECRUITING
Nitra
GASTRO I. s.r.o.
RECRUITING
Prešov
Spain
Hosp. Gral. Univ. Dr. Balmis
RECRUITING
Alicante
Hosp Reina Sofia
RECRUITING
Córdoba
Complejo Hosp Univ. de Ferrol
RECRUITING
Ferrol
Hosp. Univ. de La Paz
RECRUITING
Ferrol
Hosp. Univ. de La Princesa
RECRUITING
Madrid
Hosp. Univ. Pta. de Hierro Majadahonda
RECRUITING
Madrid
Hosp. Clinico Univ. de Valencia
RECRUITING
Valencia
Hosp. Alvaro Cunqueiro
RECRUITING
Vigo
Taiwan
Chang-Hua Christian Hospital
RECRUITING
Changhua
Far Eastern Memorial Hospital
RECRUITING
New Taipei City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2028-03-26
Participants
Target number of participants: 112
Treatments
Experimental: Guselkumab
Participants will receive guselkumab 200 milligram (mg) intravenously (IV) at week 0, 4 and 8. Afterwards, participants will be alternately assigned at study level to 2 dose cohorts, high dose (200 mg subcutaneous (SC) every 4 weeks (Q4W) starting at week 12) through week 92 or low dose (100 mg SC every 8 weeks (Q8W) starting at week 16) through week 88. Starting at Week 24, participants in the low-dose cohort will be permitted to escalate to the 200 mg SC Q4W regimen if they are symptomatic and at the discretion of the investigator.
Related Therapeutic Areas
Sponsors
Leads: Janssen-Cilag Ltd.

This content was sourced from clinicaltrials.gov

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