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New Crohn's drug shows promise in major trial

NCT ID NCT07577843

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new medicine, JNJ-78934804, against an existing drug (guselkumab) in 460 people with moderate-to-severe Crohn's disease. The goal is to see if the new drug can reduce symptoms and heal the gut lining better at 48 weeks. Participants must have had Crohn's for at least 12 weeks and have active disease. This is a long-term treatment, not a cure.

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 460 people

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

Started

May 2026

Expected to finish

Jul 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: * Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD * Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \>= 220 but less than or equal to (\<=) 450 and either: a. Mean daily stool frequency (SF) count \>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>= 2.0, based on the unweighted CDAI component of abdominal pain (AP) * Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria * Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies Exclusion criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC * Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study * Presence of draining (that is, functioning) stoma or ostomy * Has a history of short bowel syndrome, is missing greater than (\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention * Currently has or is suspected of having an abscess

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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

    142 sites in 23 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

  • Alesund sjukehus

    RECRUITING

    Ålesund, 6017, Norway

  • Algemeen Ziekenhuis Delta

    RECRUITING

    Roeselare, 8800, Belgium

  • Antalya Training And Research Hospital

    RECRUITING

    Antalya, 07100, Turkey (Türkiye)

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Asian Institute Of Gastroenterology

    RECRUITING

    Hyderabad, 500032, India

  • Assuta Medical center

    RECRUITING

    Ashdod, 7747629, Israel

  • Atlanta Gastroenterology Specialists

    RECRUITING

    Suwanee, Georgia, 30024, United States

  • BR Trials

    RECRUITING

    São Paulo, 01236 030, Brazil

  • Banksia Trials SA

    RECRUITING

    Adelaide, 5000, Australia

  • Bezmialem University Medical Faculty

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Bnai Zion Medical Center

    RECRUITING

    Haifa, 31048, Israel

  • CDC - Centro Digestivo de Curitiba

    RECRUITING

    Curitiba, 80430 180, Brazil

  • CHU de Nantes hotel Dieu

    RECRUITING

    Nantes, 44000, France

  • CHU de Reims

    RECRUITING

    Reims, 51100, France

  • CHUM - Centre hospitalier universitaire de Montreal

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

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

    RECRUITING

    Rzeszów, 35-055, Poland

  • Centrum Medyczne Medis ManerMed Sp Z O O

    RECRUITING

    Bydgoszcz, 85 229, Poland

  • Centrum Medyczne Promed

    RECRUITING

    Krakow, 31-513, Poland

  • Cer Instituto Medico

    RECRUITING

    Quilmes, B1878DVB, Argentina

  • Changzhou No 2 Peoples Hospital

    RECRUITING

    Changzhou, 213004, China

  • Chongqing General Hospital

    RECRUITING

    Chongqing, 400014, China

  • Cliged

    RECRUITING

    Macaé, 27910-020, Brazil

  • Cliniq s.r.o.

    RECRUITING

    Bratislava, 811 09, Slovakia

  • Clinique IMD

    RECRUITING

    Montreal, Quebec, H3H1E3, Canada

  • Clinnova Research

    RECRUITING

    Anaheim, California, 92805, United States

  • Digestive Disease Specialists Inc

    RECRUITING

    Oklahoma City, Oklahoma, 73114, United States

  • ENDOMED s.r.o

    RECRUITING

    Košice, 040 13, Slovakia

  • ETG Zamosc

    RECRUITING

    Zamość, 22 400, Poland

  • Eugastro GmbH

    RECRUITING

    Leipzig, 04103, Germany

  • FNsP F. D. Roosevelta Banska Bystrica

    RECRUITING

    Banská Bystrica, 975 17, Slovakia

  • Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, 14000, Czechia

  • Florida Research Center Inc.

    RECRUITING

    Lakewood Rch, Florida, 34211, United States

  • GASTRO I. s.r.o.

    RECRUITING

    Prešov, 080 01, Slovakia

  • GCP Clinical Research

    RECRUITING

    Tampa, Florida, 33609, United States

  • GEDYT

    RECRUITING

    AAI, C1425BGC, Argentina

  • GI Alliance Tacoma

    RECRUITING

    Tacoma, Washington, 98405, United States

  • GI Research Institute (G.I.R.I.)

    RECRUITING

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Galilee Medical Center

    RECRUITING

    Nahariya, 2210001, Israel

  • Gastro LM s.r.o.

    RECRUITING

    Prešov, 080 01, Slovakia

  • Gastro One

    RECRUITING

    Cordova, Tennessee, 38018, United States

  • Gastro SB Clinic

    RECRUITING

    Chula Vista, California, 91910, United States

  • Gastroenterology Clinic of Acadiana

    RECRUITING

    Lafayette, Louisiana, 70503, United States

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    RECRUITING

    Edmonton, Alberta, T5R 1W2, Canada

  • Ghent University Hospital

    RECRUITING

    Ghent, 9000, Belgium

  • Globalpsy

    RECRUITING

    La Plata, 1896, Argentina

  • Great Lakes Gastroenterology Research, LLC

    RECRUITING

    Mentor, Ohio, 44060, United States

  • Gujarat Gastro and Vascular Hospital

    RECRUITING

    Surat, 395009, India

  • HIGEA

    RECRUITING

    Mendoza, M5500DPS, Argentina

  • Hamamatsu University Hospital

    RECRUITING

    Hamamatsu, 431-3192, Japan

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

    RECRUITING

    Hradec Králové, 500 12, Czechia

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    RECRUITING

    Sapporo, 060-0033, Japan

  • Hosp. Alvaro Cunqueiro

    RECRUITING

    Vigo, 36312, Spain

  • Hosp. Univ. Infanta Leonor

    RECRUITING

    Madrid, 28031, Spain

  • Hospital Ampang

    RECRUITING

    Ampang, 68000, Malaysia

  • Hospital De Clinicas De Porto Alegre

    RECRUITING

    Porto Alegre, 90035 903, Brazil

  • Hospital Ernesto Dornelles

    RECRUITING

    Porto Alegre, 90160 093, Brazil

  • Hospital Queen Elizabeth

    RECRUITING

    Kota Kinabalu, 88586, Malaysia

  • Hospital Sultanah Nur Zahirah

    RECRUITING

    Kuala, 20400, Malaysia

  • Huai'an 1st Hospital

    RECRUITING

    Huai'an, 223300, China

  • IBD SA

    RECRUITING

    Kurralta Park, 5037, Australia

  • INTEGRAL Pesquisa e Ensino

    RECRUITING

    Votuporanga, 15500-269, Brazil

  • ISCARE a.s.

    RECRUITING

    Prague, 190 00, Czechia

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Busan, 48108, South Korea

  • Izmir Sehir Hastanesi

    RECRUITING

    Izmir, 35540, Turkey (Türkiye)

  • Japanese Red Cross Kumamoto Hospital

    RECRUITING

    Kumamoto, 861-8520, Japan

  • Japanese Red Cross Osaka Hospital

    RECRUITING

    Osaka, 543-8555, Japan

  • John Hunter Hospital

    RECRUITING

    New Lambton Heights, 2305, Australia

  • KM Management spol. s r.o.

    RECRUITING

    Nitra, 949 01, Slovakia

  • Kagoshima IBD Gastroenterology Clinic

    RECRUITING

    Kagoshima, 892-0843, Japan

  • Kitasato University Kitasato Institute Hospital

    RECRUITING

    Minatoku, 108-8642, Japan

  • Kobe University Hospital

    RECRUITING

    Kobe, 650 0017, Japan

  • Kocaeli University Medical Faculty

    RECRUITING

    Kocaeli, 41001, Turkey (Türkiye)

  • Krankenhaus Waldfriede Mitte

    RECRUITING

    Berlin, 14163, Germany

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, 860-8556, Japan

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 333, Taiwan

  • Lisie Hospital

    RECRUITING

    Kochi, 682018, India

  • London Digestive Disease Institute

    RECRUITING

    London, Ontario, N6K 1M6, Canada

  • Marmara University Pendik Training Hospital

    RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

  • Mater Misericordiae Hospital

    RECRUITING

    South Brisbane, 4101, Australia

  • Medical Associates Research Group, Inc.

    RECRUITING

    San Diego, California, 92123, United States

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Medrise Sp. z o.o.

    RECRUITING

    Lublin, 20 582, Poland

  • Meir Medical Center

    RECRUITING

    Kfar Saba, 44281, Israel

  • Mersin University Medical Faculty

    RECRUITING

    Mersin, 33343, Turkey (Türkiye)

  • Michigan Center of Medical Research

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, 3168, Australia

  • Nagoya City University Hospital

    RECRUITING

    Nagoya, 467-8602, Japan

  • National Hospital Organization Hirosaki National Hospital

    RECRUITING

    Hirosaki, 036-8545, Japan

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osaka, 540-0006, Japan

  • National Hospital Organization Shizuoka Medical Center

    RECRUITING

    Shimizu, 411-8611, Japan

  • New York Gastroenterology Associates

    RECRUITING

    New York, New York, 10075, United States

  • Ningbo medical center lihuili hospital

    RECRUITING

    Ningbo, 315041, China

  • Peak Gastroenterology Associates

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Pesquisare Saude

    RECRUITING

    Santo André, 09080-110, Brazil

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Radboud Umcn

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • Rocco And Nazato Servicos Medicos Ltda

    RECRUITING

    São Paulo, 04077-020, Brazil

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, 2050, Australia

  • S. R. Kalla Memorial General Hospital

    RECRUITING

    Jaipur, 302006, India

  • SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre

    RECRUITING

    Surat, 395002, India

  • Samsung Medical Center

    RECRUITING

    Gangnam Gu, 06351, South Korea

  • Sanchez Clinical Research, Inc

    RECRUITING

    Miami, Florida, 33157-6575, United States

  • Sapporo Higashi Tokushukai Hospital

    RECRUITING

    Sapporo, 065-0033, Japan

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310000, China

  • South Edmonton Gastroenterology Research Clinic

    RECRUITING

    Edmonton, Alberta, Code: T6K 4B2, Canada

  • St. Olavs Hospital

    RECRUITING

    Trondheim, 7030, Norway

  • Sultan Idris Shah Hospital

    RECRUITING

    Kajang, 43000, Malaysia

  • Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

    RECRUITING

    Guangzhou, 510655, China

  • Sushruta Multispecialty Hospital and Research Centre

    RECRUITING

    Hubballi, 580021, India

  • Takamatsu Red Cross Hospital

    RECRUITING

    Takamatsu, 760-0017, Japan

  • Takano Hospital

    RECRUITING

    Kumamoto, 862-0971, Japan

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 64239, Israel

  • The Catholic University of Korea Daejeon St Mary's Hospital

    RECRUITING

    Daejeon, 34943, South Korea

  • The Melbourne Gut Clinic Epworth Hospital

    RECRUITING

    East Melbourne, 3002, Australia

  • The Oregon Clinic

    RECRUITING

    Portland, Oregon, 97220, United States

  • Toronto Immune and Digestive Health Institute Inc

    RECRUITING

    Toronto, Ontario, M6A 3B4, Canada

  • Tri-State Gastroenterology Assoc

    RECRUITING

    Crestview Hills, Kentucky, 41017, United States

  • Tsujinaka Hospital Kashiwanoha

    RECRUITING

    Kashiwa, 277-0871, Japan

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    RECRUITING

    Szczecin, 71-434, Poland

  • Tyler Research Institute, LLC

    RECRUITING

    Tyler, Texas, 75701, United States

  • Uls Braga - Hosp. Braga

    RECRUITING

    Braga, 4710 243, Portugal

  • Ulsam - Hosp. Santa Luzia

    RECRUITING

    Viana do Castelo, 4900-408, Portugal

  • United Medical Doctors

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Universitaetsklinikum Mannheim

    RECRUITING

    Mannheim, 68167, Germany

  • Universitaetsmedizin Rostock

    RECRUITING

    Rostock, 18057, Germany

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitatsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

  • Universitatsklinikum Schleswig Holstein Kiel

    RECRUITING

    Kiel, 24105, Germany

  • Universitetssykehuset Nord-Norge HF

    RECRUITING

    Tromsø, 9038, Norway

  • University Malaya Medical Centre

    RECRUITING

    Petaling Jaya, 50603, Malaysia

  • University of North Carolina Hospital

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Viable Clinical Research

    RECRUITING

    Kentville, Nova Scotia, B4N 0A3, Canada

  • West GTA Research Inc

    RECRUITING

    Mississauga, Ontario, L5M 2S4, Canada

  • Wolfson Medical Center

    RECRUITING

    Holon, 5822012, Israel

  • Yamanashi Prefectural Central Hospital

    RECRUITING

    Yamanashi, 400-8506, Japan

  • Yashoda Super Speciality Hospitals

    RECRUITING

    Secunderabad, 500003, India

  • ZhuZhou Central Hospital

    RECRUITING

    Zhuzhou, 412007, China

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