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Head-to-Head drug battle aims to tame Crohn's Flare-Ups

NCT ID NCT07499232

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether guselkumab works better than risankizumab for people with moderate to severe Crohn's disease. About 530 adults will receive one of the two drugs and be followed for a year. The goal is to see which drug leads to deeper remission, meaning fewer symptoms and less gut inflammation.

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

About 530 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2030

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 CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy * Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\>=) 220 but less than or equal to (\<=) 450 * Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) \>= 4 (for participants with isolated ileal disease) or \>= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: 1. a minimum score of 1 for the component of "size of ulcers" AND 2. a minimum score of 1 for the component of "ulcerated surface" * In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study * Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol Exclusion criteria * Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, 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 or risankizumab * Currently has or is suspected to have an abscess * Has an active fistula during screening or at Week 0 with an anticipated need for surgery * Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention * Currently has a malignancy or has a history of malignancy within 5 years before screening

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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 disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    160 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A O U Sant Orsola Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • APHP - Hopital Bichat - Claude Bernard

    RECRUITING

    Paris, 75018, France

  • Aarhus University Hospital

    RECRUITING

    Aarhus C, 8200, Denmark

  • Akademiska Sjukhuset

    RECRUITING

    Uppsala, 751 85, Sweden

  • Algemeen Ziekenhuis Delta

    RECRUITING

    Roeselare, 8800, Belgium

  • Aphm - Hopital Nord

    RECRUITING

    Marseille, 13015, France

  • Aphp Hopital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • Atlanta Gastroenterology Associates

    SUSPENDED

    Atlanta, Georgia, 30342, United States

  • Azienda Ospedaliero Universitaria San Martino

    RECRUITING

    Genova, 16132, Italy

  • Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano

    RECRUITING

    Bolzano, 39100, Italy

  • Barts Health NHS Trust

    RECRUITING

    Greater London, E1 2AJ, United Kingdom

  • Biodax Medical Research Trials

    RECRUITING

    Miami, Florida, 33186, United States

  • Bispebjerg Hospital

    RECRUITING

    København NV, 2400, Denmark

  • CHU Amiens Picardie

    RECRUITING

    Amiens, 80000, France

  • CHU Nantes - Hotel Dieu

    RECRUITING

    Nantes, 44000, France

  • CHU Nimes

    RECRUITING

    Nîmes, 30900, France

  • CHU de Liege

    RECRUITING

    Liège, 4000, Belgium

  • CHU de Reims

    RECRUITING

    Reims, 51100, France

  • Centre Hospitalier Universitaire de Nancy - Hôpital Central

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Hospitalier de l'Universite de Montreal

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

  • Centrum Medyczne 'Medyk' Sp. z o.o. K.

    RECRUITING

    Rzeszów, 35-326, Poland

  • Centrum Medyczne Medis ManerMed Sp Z O O

    RECRUITING

    Bydgoszcz, 85 229, Poland

  • Centrum Medyczne Plejady

    RECRUITING

    Krakow, 30363, Poland

  • Centrum Medyczne Promed

    RECRUITING

    Krakow, 31-513, Poland

  • Changzhou No 2 Peoples Hospital

    RECRUITING

    Changzhou, 213018, China

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

    RECRUITING

    Berlin, 12203, Germany

  • Charlotte Gastroenterology and Hepatology, PLLC

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Charlton Digestive Disease Centre

    RECRUITING

    Hamilton, Ontario, L8N1Y2, Canada

  • Chelsea And Westminster Hospital

    RECRUITING

    London, SW10 9NH, United Kingdom

  • Chongqing General Hospital

    RECRUITING

    Chongqing, 400014, China

  • Clermont Ferrand University Hospital

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Clinexpert Gyongyos Kft

    RECRUITING

    Gyöngyös, 3200, Hungary

  • Cliniq s.r.o.

    RECRUITING

    Bratislava, 811 09, Slovakia

  • Clinique Ambroise Pare

    RECRUITING

    Neuilly-sur-Seine, 92200, France

  • Clinique IMD

    RECRUITING

    Montreal, Quebec, H3H1E3, Canada

  • Cliniques Universitaires Saint Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Clinnova Research

    RECRUITING

    Anaheim, California, 92805, United States

  • Comprehensive Gastrointestinal Health Libertyville

    SUSPENDED

    Northbrook, Illinois, 60062, United States

  • Cotton-O'Neil Clinical Research Center

    RECRUITING

    Topeka, Kansas, 66606, United States

  • DFW Clinical Trials

    RECRUITING

    Carrollton, Texas, 75010, United States

  • Digestive Disease Specialists Inc

    RECRUITING

    Oklahoma City, Oklahoma, 73114, United States

  • Digestive Health Specialists of the Southeast

    RECRUITING

    Dothan, Alabama, 36305, United States

  • ENDOMED s.r.o

    RECRUITING

    Košice, 040 13, Slovakia

  • East View Medical Research

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Endomedix

    RECRUITING

    Budapest, 1139, Hungary

  • Ersta sjukhus

    RECRUITING

    Stockholm, 116 30, Sweden

  • FNsP F. D. Roosevelta Banska Bystrica

    RECRUITING

    Banská Bystrica, 975 17, Slovakia

  • Fakultna nemocnica s poliklinikou Nove Zamky

    RECRUITING

    Nové Zámky, 940 34, Slovakia

  • Fakultni Nemocnice Ostrava

    RECRUITING

    Ostrava-Poruba, 708 00, Czechia

  • Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, 14000, Czechia

  • Fakultni nemocnice Brno

    RECRUITING

    Brno, 62500, Czechia

  • Fakultni nemocnice Kralovske Vinohrady

    RECRUITING

    Prague, 100 00, Czechia

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Frontier Clinical Research

    RECRUITING

    Uniontown, Pennsylvania, 15401, United States

  • GASTRO I. s.r.o.

    RECRUITING

    Prešov, 080 01, Slovakia

  • GASTRO-Studien

    RECRUITING

    Berlin, 10825, Germany

  • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii

    RECRUITING

    Torun, 87 100, Poland

  • GCP Clinical Research

    RECRUITING

    Tampa, Florida, 33609, United States

  • GI Pros Research

    RECRUITING

    Naples, Florida, 34102, United States

  • GIRI Gastrointestinal Research Institute

    RECRUITING

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Gastro Care Institute

    RECRUITING

    Lancaster, California, 93534, United States

  • Gastro LM s.r.o.

    RECRUITING

    Prešov, 080 01, Slovakia

  • GastroIntestinal Bioscience

    RECRUITING

    Los Angeles, California, 90067, United States

  • Gastroenterologie, s.r.o., Hradec Kralove

    RECRUITING

    Hradec Kralova, 500 02, Czechia

  • Gastroenterology Associates of Central GA

    RECRUITING

    Macon, Georgia, 31201, United States

  • Gastroenterology Clinic of Acadiana

    RECRUITING

    Lafayette, Louisiana, 70503, United States

  • Gastroenterology Research of America, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    RECRUITING

    Edmonton, Alberta, T5R 1W2, Canada

  • Ghent University Hospital

    RECRUITING

    Ghent, 9000, Belgium

  • Great Lakes Gastroenterology Research, LLC

    RECRUITING

    Mentor, Ohio, 44060, United States

  • Green Leaf Clinical Trials

    RECRUITING

    Jacksonville, Florida, 32258, United States

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

    RECRUITING

    Hradec Králové, 500 12, Czechia

  • Herlev Hospital

    RECRUITING

    Herlev, 2730, Denmark

  • Hoag Memorial Hospital

    SUSPENDED

    Newport Beach, California, 92663, United States

  • Hosp. Arquitecto Marcide

    RECRUITING

    Ferrol, 15405, Spain

  • Hosp. Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hosp. Clinico Univ. de Santiago

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hosp. Gral. Univ. Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hosp. Univ. Dr. Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • Hosp. Univ. de Torrejon

    RECRUITING

    Madrid, 28850, Spain

  • Hosp. Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hosp. de Cabuenes

    RECRUITING

    Gijón, 33394, Spain

  • Hosp. de Navarra

    RECRUITING

    Navarra, 31008, Spain

  • Hospices Civils de Lyon CHU Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • Hvidovre Hospital

    RECRUITING

    Hvidovre, 2650, Denmark

  • IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, 20132, Italy

  • Imperial College London

    RECRUITING

    London, W120HS, United Kingdom

  • Institut Prive MICI Clinique des Cedres

    RECRUITING

    Échirolles, 38130, France

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • Karolinska Universitetssjukhuset

    RECRUITING

    Stockholm, 171 76, Sweden

  • Kepler Universitatsklinikum GmbH

    RECRUITING

    Linz, 4021, Austria

  • Klinikum Wels Grieskirchen

    RECRUITING

    Wels, 4600, Austria

  • Klinikum rechts der Isar der TU Munchen

    RECRUITING

    München, 81675, Germany

  • Krankenhaus der Barmherzigen Brüder

    RECRUITING

    Vienna, 1020, Austria

  • LKH - Universitätsklinikum der PMU Salzburg

    RECRUITING

    Salzburg, 5020, Austria

  • LKH-Univ. Klinikum Graz

    RECRUITING

    Graz, 8036, Austria

  • Linkoping University Hospital

    RECRUITING

    Linköping, 58185, Sweden

  • London Digestive Disease Institute

    RECRUITING

    London, Ontario, N6K 1M6, Canada

  • London North West University Healthcare NHS Trust

    RECRUITING

    Greater London, NW10 7NS, United Kingdom

  • Lubbock Gastroenterology

    RECRUITING

    Lubbock, Texas, 79424, United States

  • Lucida Clinical Trials

    RECRUITING

    New Bedford, Massachusetts, 02740, United States

  • Maastricht UMC

    RECRUITING

    Maastricht, 6229 HX, Netherlands

  • Medical Associates Research Group, Inc.

    RECRUITING

    San Diego, California, 92123, United States

  • Medical Network Sp z o o

    RECRUITING

    Warsaw, 04 501, Poland

  • Medical Research Center of Connecticut

    RECRUITING

    Hamden, Connecticut, 06518, United States

  • Medizinische Universitatsklinik Innsbruck

    RECRUITING

    Innsbruck, 6020, Austria

  • Michigan Center of Medical Research

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Morehouse School of Medicine

    RECRUITING

    Atlanta, Georgia, 30310, United States

  • NAU New Aalborg University Hospital

    RECRUITING

    Gistrup, 9260, Denmark

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    RECRUITING

    Warsaw, 02-781, Poland

  • New Cross Hospital

    RECRUITING

    Wolverhampton, WV10 0QP, United Kingdom

  • New York Gastroenterology Associates

    RECRUITING

    New York, New York, 10075, United States

  • Nordsjaellands Hospital, Hillerod

    RECRUITING

    Hilleroed, 3400, Denmark

  • Norfolk and Norwich University Hospital

    RECRUITING

    Norwich, NR4 7UQ, United Kingdom

  • Obudai Egeszsegugyi Centrum Kft

    RECRUITING

    Budapest, 1036, Hungary

  • Odense UH og Svendberg sygehus

    RECRUITING

    Odense C, 5000, Denmark

  • Ospedale Mauriziano Torino

    RECRUITING

    Torino, 10128, Italy

  • Palmetto Primary and Specialty Care Physicians, Charleston

    RECRUITING

    Summerville, South Carolina, 29486, United States

  • Pannónia Magánorvosi Centrum Kft

    RECRUITING

    Budapest, H-1136, Hungary

  • Peak Gastroenterology Associates

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich

    RECRUITING

    Grevenbroich, 41515, Germany

  • Radboud Umcn

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, China

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    RECRUITING

    Mölndal, 431 30, Sweden

  • Sanchez Clinical Research, Inc

    RECRUITING

    Miami, Florida, 33157-6575, United States

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1088, Hungary

  • Semmelweis Egyetem 1

    RECRUITING

    Budapest, 1082, Hungary

  • Semmelweis Egyetem 2

    RECRUITING

    Budapest, 1083, Hungary

  • Sodersjukhuset

    RECRUITING

    Stockholm, 118 83, Sweden

  • Southern Star Research Institute, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • St. Elisabeth Ziekenhuis

    RECRUITING

    Tilburg, 5022 GC, Netherlands

  • St. Marien und St. Annastiftskrankenhaus

    RECRUITING

    Ludwigshafen am Rhein, 67067, Germany

  • Sydvestjysk Sygehus

    RECRUITING

    Esbjerg, 6700, Denmark

  • Szegedi Tudomanyegyetem

    RECRUITING

    Szeged, 6725, Hungary

  • TLC Clinical Research Inc

    RECRUITING

    Los Angeles, California, 90048, United States

  • Taunton Surgical Centre

    RECRUITING

    Oshawa, Ontario, L1J 0C7, Canada

  • The Second Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, 510261, China

  • The Sixth Affiliated Hospital Sun Yat sen University

    RECRUITING

    Guangzhou, 510655, China

  • The University of Texas Health Science Center at Tyler

    RECRUITING

    Tyler, Texas, 75708, United States

  • Toronto Immune and Digestive Health Institute Inc

    RECRUITING

    Toronto, Ontario, M6A 3B4, Canada

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    RECRUITING

    Szczecin, 71-434, Poland

  • ULB Erasme Ziekenhuis

    RECRUITING

    Brussels, 1070, Belgium

  • UT Southwestern

    SUSPENDED

    Dallas, Texas, 75390, United States

  • United Gastroenterologists

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Universitaetsklinikum Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitatsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitatsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • Universitatsklinikum Schleswig Holstein Kiel

    RECRUITING

    Kiel, 24105, Germany

  • Universitatsklinikum Wiener Neustadt

    RECRUITING

    Wiener Neustadt, 2700, Austria

  • University College London Hospitals Nhs Foundation Trust

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599 7080, United States

  • Vojenska nemocnice Brno

    RECRUITING

    Brno, 636 00, Czechia

  • Vseobecna nemocnica Rimavska Sobota

    RECRUITING

    Rimavská Sobota, 979 12, Slovakia

  • West Middlesex University Hospital

    RECRUITING

    Iselworth, TW7 6AF, United Kingdom

  • Westchester Putnam Gastroenterology

    RECRUITING

    Carmel, New York, 10512, United States

  • Woodholme Gastroenterology Associates

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • Zhongda Hospital Southeast University

    RECRUITING

    Nanjing, 210009, China

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, 3600, Belgium

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