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Can this drug fully heal the gut in Crohn's?

NCT ID NCT06408935

Disease control Sponsor: Janssen-Cilag Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests a drug called guselkumab in 120 people with Crohn's disease to see if it can heal all layers of the digestive tract. The main goal is to check healing using an MRI scan after 48 weeks of treatment. Participants must have active Crohn's disease and will receive the study drug in an open-label design.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

120 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

Contacts and locations

Locations

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018, France

  • ASL Toscana Nord Ovest PO Valdera Ospedale Lotti

    Pontedera Pisa, 56025, Italy

  • ASST Fatebenefratelli Sacco

    Milan, 20121, Italy

  • AZ Maria Middelares

    Ghent, 9000, Belgium

  • Aphm - Hopital Nord

    Marseille, 13915, France

  • Asst Rhodense - Ospedale Di Rho

    Rho, 20017, Italy

  • Azienda Ospedaliera Policlinico S. Orsola-Malpighi

    Bologna, 40138, Italy

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59000, France

  • CHU Amiens Picardie

    Amiens, 80054, France

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63000, France

  • CHU de Liege

    Liège, 4000, Belgium

  • CHU de Nantes hotel Dieu

    Nantes, 44000, France

  • Center for Colitis and Crohns Disease University of California

    San Francisco, California, 94115, United States

  • Centrum Medyczne Medyk

    Rzeszów, 35-326, Poland

  • Centrum Medyczne Oporow

    Wroclaw, 52-416, Poland

  • Chang-Hua Christian Hospital

    Changhua, 500, Taiwan

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117, Germany

  • Cliged

    Macaé, 27910-020, Brazil

  • Cliniq s.r.o.

    Bratislava, 811 09, Slovakia

  • Complejo Hosp Univ. de Ferrol

    Ferrol, 15405, Spain

  • Concord Repatriation General Hospital

    Concord, 2139, Australia

  • ENDOMED s.r.o

    Košice, 040 13, Slovakia

  • ETG Zamosc

    Zamość, 22-400, Poland

  • EuroMediCare Szpital Specjalistyczny z Przychodnia

    Wroclaw, 54 144, Poland

  • FNsP F.D.R. Banska Bystrica

    Banská Bystrica, 975 17, Slovakia

  • Far Eastern Memorial Hospital

    New Taipei City, 22060, Taiwan

  • Fiona Stanley Hospital

    Murdoch, 6150, Australia

  • Fondazione Policlinico Tor Vergata

    Roma, 00133, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168, Italy

  • Foothills Hospital

    Calgary, Alberta, T2N 4Z6, Canada

  • GASTRO I. s.r.o.

    Prešov, 080 01, Slovakia

  • GASTROMED Sp. z o.o.

    Torun, 87 100, Poland

  • Galilee Medical Center

    Nahariya, 2210001, Israel

  • Hadassah Medical Organization

    Jerusalem, 91200, Israel

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12, Czechia

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5, Canada

  • Hosp Reina Sofia

    Córdoba, 14004, Spain

  • Hosp. Alvaro Cunqueiro

    Vigo, 36213, Spain

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010, Spain

  • Hosp. Gral. Univ. Dr. Balmis

    Alicante, 3010, Spain

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Madrid, 28222, Spain

  • Hosp. Univ. de La Paz

    Ferrol, 15405, Spain

  • Hosp. Univ. de La Princesa

    Madrid, 28006, Spain

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 15501-405, Brazil

  • IRCCS Humanitas Rozzano-IBD Center Malattie Infiammatorie Croniche Intestinali

    Rozzano, 20089, Italy

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • ISCARE a.s.

    Prague, 19000, Czechia

  • Instituto Mederi de Pesquisa e Saude

    Passo Fundo, 99010-120, Brazil

  • KM Management spol. s r.o.

    Nitra, 949 01, Slovakia

  • Klinikum Augsburg

    Augsburg, D-86158, Germany

  • MVZ Portal 10

    Münster, 48155, Germany

  • Mater Hospital Brisbane

    South Brisbane, 4101, Australia

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medizinisches Versorgungszentrum (MVZ) Dachau

    Dachau, 85221, Germany

  • Melita Medical Sp. z o.o.

    Wroclaw, 50 449, Poland

  • NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul

    Porto Alegre, 90430001, Brazil

  • NZOZ Centrum Medyczne KERmed

    Bydgoszcz, 85 231, Poland

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nemocnice Ceske Budejovice a s

    České Budějovice, 370 87, Czechia

  • Northern Hospital

    Melbourne, 3076, Australia

  • Praxis Fur Gastroenteroligie

    Berlin, 10825, Germany

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Rambam Medical Center

    Haifa, 31096, Israel

  • Siloah St Trudpert Klinikum

    Pforzheim, 75179, Germany

  • Staedtisches Klinikum Lueneburg

    Lüneburg, 21339, Germany

  • Studiengesellschaft Mitteldeutschland GmbH

    Halle, 06108, Germany

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • The Edith Wolfson Medical Center

    Holon, 58100, Israel

  • The Queen Elizabeth Hospital

    Adelaide, 5011, Australia

  • The University of Chicago Medical Center (UCMC)

    Chicago, Illinois, 60637, United States

  • Universita Campus Bio-Medico di Roma

    Roma, 00128, Italy

  • Universita Di Napoli Federico Ii

    Naples, 80131, Italy

  • Universitaetsklinikum Ulm

    Ulm, 89081, Germany

  • Universitatsklinikum Frankfurt/ Medizinische Klinik 1

    Frankfurt, 60590, Germany

  • Universitatsklinikum Schleswig Holstein

    Kiel, 24105, Germany

  • Universitatsmedizin Gottingen

    Göttingen, 37075, Germany

  • Vitaz

    Sint-Niklaas, Belgium

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728, Poland

  • Washington University School Of Medicine

    St Louis, Missouri, 63110, United States

  • Western University & London Health Sciences Centre

    London, Ontario, N6A 5A5, Canada

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