Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients
NCT ID: NCT06408935
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
112 participants
INTERVENTIONAL
2024-04-17
2028-03-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Guselkumab
Guselkumab will be administered IV and SC.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Guselkumab
Guselkumab will be administered IV and SC.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen-Cilag Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Cilag Ltd. Clinical trial
Role: STUDY_DIRECTOR
Janssen-Cilag Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Colitis and Crohns Disease University of California
San Francisco, California, 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
Napoli, , 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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNTO1959CRD3008
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504040-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CNTO1959CRD3008
Identifier Type: -
Identifier Source: org_study_id