Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for ulcerative colitis: experimental drug JNJ-78934804 enters final testing phase

NCT ID NCT07577856

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 28, 2026 · Updated 6 times

Summary

This phase 3 trial tests whether the experimental drug JNJ-78934804 can help people with moderate to severe ulcerative colitis achieve remission better than the existing drug guselkumab. About 644 participants will receive either the new drug or guselkumab, and researchers will check at 48 weeks how many have no symptoms and healed gut lining. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JNJ-78934804 (an experimental drug) compared to guselkumab (TREMFYA)
What this could lead to
If successful, this could provide a new treatment option for people with moderate to severe ulcerative colitis, potentially helping more patients achieve remission.
What could go wrong
This is a phase 3 trial, but the experimental drug is still unproven. It may not work better than the existing drug guselkumab, and side effects are possible.

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 644 people

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

Started

May 2026

Expected to finish

Oct 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: * Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC. * Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy * An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy * Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies Exclusion criteria: * Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD * Has a history of or ongoing chronic or recurrent infectious disease * Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab * Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colitis ulcerative are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Colitis ulcerative

How to take part

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

  1. The places running it

    170 sites in 26 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

  • AZ Maria Middelares

    RECRUITING

    Ghent, 9000, Belgium

  • AZ Sint-Lucas

    RECRUITING

    Bruges, 8310, Belgium

  • Aichi Medical University Hospital

    RECRUITING

    Nagakute, 480-1195, Japan

  • Alesund sjukehus

    RECRUITING

    Ålesund, 6017, Norway

  • 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

  • Barrie GI Associates

    RECRUITING

    Barrie, Ontario, L4M 7G1, Canada

  • Beijing Friendship Hospital Capital Medical University

    RECRUITING

    Beijing, 100050, China

  • Bezmialem University Medical Faculty

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Bnai Zion Medical Center

    RECRUITING

    Haifa, 60910, Israel

  • CDC - Centro Digestivo de Curitiba

    RECRUITING

    Curitiba, 80430 180, Brazil

  • CHU de Lille Hopital Claude Huriez

    RECRUITING

    Lille, 59037, France

  • 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

  • Center Hospital of the National Center for Global Health and Medicine

    RECRUITING

    Shinjuku Ku, 162 8655, Japan

  • Centrum Medyczne Medis ManerMed Sp Z O O

    RECRUITING

    Bydgoszcz, 85 229, Poland

  • Centrum Medyczne Medyk

    RECRUITING

    Rzeszów, 35-326, Poland

  • Centrum Medyczne Promed

    RECRUITING

    Krakow, 31-513, Poland

  • Changzhou No 2 Peoples Hospital

    RECRUITING

    Changzhou, 213000, China

  • Charlton Digestive Disease Centre

    RECRUITING

    Hamilton, Ontario, L8N1Y2, Canada

  • Chongqing General Hospital

    RECRUITING

    Chongqing, 400014, China

  • Cliniq s.r.o.

    RECRUITING

    Bratislava, 811 09, Slovakia

  • Clinique IMD

    RECRUITING

    Montreal, Quebec, H3H1E3, Canada

  • Clinnova Research

    RECRUITING

    Anaheim, California, 92805, United States

  • Diagnostic Consultative Center Neoclinic EAD

    RECRUITING

    Sofia, 1408, Bulgaria

  • Digestive Disease Specialists Inc

    RECRUITING

    Oklahoma City, Oklahoma, 73114, United States

  • EMC Instytut Medyczny S A Penta Hospitals Przychodnie

    RECRUITING

    Wroclaw, 54-239, Poland

  • 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

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, 6150, Australia

  • 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

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

    RECRUITING

    Hradec Kralova, 500 02, Czechia

  • 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

  • Herlev Hospital

    RECRUITING

    Herlev, 2730, Denmark

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

    RECRUITING

    Sapporo, 060-0033, Japan

  • Hosp. Gral. Univ. Dr. Balmis

    RECRUITING

    Alicante, 03010, 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, 90160-092, Brazil

  • Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 50586, Malaysia

  • Hospital Sultanah Nur Zahirah

    RECRUITING

    Kuala Terengganu, 20400, Malaysia

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto

    RECRUITING

    Ribeirão Preto, 14051140, Brazil

  • Huai'an 1st Hospital

    RECRUITING

    Huai'an, 223300, China

  • Hvidovre Hospital

    RECRUITING

    Hvidovre, 2650, Denmark

  • INTEGRAL Pesquisa e Ensino

    RECRUITING

    Votuporanga, 15500-269, Brazil

  • ISCARE a.s.

    RECRUITING

    Prague, 190 00, Czechia

  • Imelda Bonheiden

    RECRUITING

    Bonheiden, 2820, Belgium

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Busan, 48108, South Korea

  • Instituto Medico De Alta Complejidad (IMAC)

    RECRUITING

    Buenos Aires, B1643CRO, Argentina

  • Instituto de Investigaciones Clinicas Quilmes

    RECRUITING

    Quilmes, B1878GEG, Argentina

  • Istanbul University Cerrahpasa Medical Faculty

    RECRUITING

    Istanbul, 34098, Turkey (Türkiye)

  • Izmir Sehir Hastanesi

    RECRUITING

    Izmir, 35540, Turkey (Türkiye)

  • 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

  • Kings College Hospital

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Kitasato University Kitasato Institute Hospital

    RECRUITING

    Minatoku, 108-8642, 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

  • MHAT Sv. Karidad EAD

    RECRUITING

    Plovdiv, 4004, Bulgaria

  • MR Medicina Reumatologica

    RECRUITING

    San Fernando, B1646, Argentina

  • Mater Misericordiae Hospital

    RECRUITING

    South Brisbane, 4101, Australia

  • Matsuda Hospital

    RECRUITING

    Hamamatsu, 432-8061, Japan

  • 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, 4428164, 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

  • Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

    RECRUITING

    Sofia, 1407, Bulgaria

  • National Hospital Organization Mito Medical Center

    RECRUITING

    Higashi-Ibaraki, 311-3193, Japan

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osaka, 540-0006, Japan

  • National Hospital Organization Shizuoka Medical Center

    RECRUITING

    Shimizu, 411-8611, Japan

  • Nemocnice Ceske Budejovice a s

    RECRUITING

    České Budějovice, 37001, Czechia

  • New York Gastroenterology Associates

    RECRUITING

    New York, New York, 10075, United States

  • Ningbo medical center lihuili hospital

    RECRUITING

    Ningbo, 315000, China

  • Odense University Hospital

    RECRUITING

    Odense, 5000, Denmark

  • Oita Red Cross Hospital

    RECRUITING

    Ōita, 870-0033, Japan

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, 545-8585, Japan

  • 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

  • SA Gastrointestinal Services

    RECRUITING

    Kurralta Park, 5037, Australia

  • SIDS Hospital & Research Centre

    RECRUITING

    Surat, 395002, India

  • Saga University Hospital

    RECRUITING

    Saga, 849-8501, Japan

  • Samsung Medical Center

    RECRUITING

    Gangnam Gu, 06351, South Korea

  • Sanchez Clinical Research, Inc

    RECRUITING

    Miami, Florida, 33157-6575, United States

  • Sanko Universitesi Hastanesi

    RECRUITING

    Gaziantep, 27090, Turkey (Türkiye)

  • Sapporo Higashi Tokushukai Hospital

    RECRUITING

    Sapporo, 065-0033, Japan

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

  • Sonomed Sp. z o.o.

    RECRUITING

    Szczecin, 71-685, Poland

  • South Edmonton Gastroenterology Research Clinic

    RECRUITING

    Edmonton, Alberta, Code: T6K 4B2, Canada

  • Southern Star Research Institute, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • St Georges Healthcare NHS Trust

    RECRUITING

    London, SW17 0QT, United Kingdom

  • 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

  • Sykehuset Innlandet HF Gjøvik

    RECRUITING

    Gjøvik, 2819, Norway

  • Taipei Mackay Memorial Hospital

    RECRUITING

    Taipei, 10449, Taiwan

  • 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 First Affiliated Hospital Sun Yat sen University

    RECRUITING

    Guangzhou, 510080, China

  • The Melbourne Gut Clinic Epworth Hospital

    RECRUITING

    East Melbourne, 3002, Australia

  • The Oregon Clinic

    RECRUITING

    Portland, Oregon, 97220, United States

  • The Second Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, 050000, China

  • Tokyo Metropolitan Bokutoh Hospital

    RECRUITING

    Sumida Ku, 130 8575, Japan

  • 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

  • ULB Erasme Ziekenhuis

    RECRUITING

    Brussels, 1070, Belgium

  • UZ Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • Uls Braga - Hosp. Braga

    RECRUITING

    Braga, 4710 243, Portugal

  • Uls Santa Maria - Hosp. Santa Maria

    RECRUITING

    Lisbon, 1649 028, 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 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

    Kuala Lumpur, 59100, Malaysia

  • Viable Clinical Research

    RECRUITING

    Kentville, Nova Scotia, B4N 0A3, 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.