RecruitingRecruiting
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
NCT07577843 · Janssen Research & Development, LLC
In plain English
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Official title
A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
About this study
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).
Eligibility criteria
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
Study design
Enrollment target: 460 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-05-22
Estimated completion: 2030-07-12
Last updated: 2026-08-28
Interventions
Drug: JNJ-78934804Drug: Guselkumab
Primary outcomes
- • Co-Primary: Percentage of Participants with Clinical Remission at Week 48 (At Week 48)
- • Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48 (At Week 48)
Sponsor
Janssen Research & Development, LLC · industry
Contacts & investigators
ContactStudy Contact · contact · Participate-In-This-Study1@its.jnj.com · 844-434-4210
InvestigatorJanssen Research & Development, LLC Clinical Trial · study_director, Janssen Research & Development, LLC
All locations (142)
Clinnova ResearchRecruiting
Anaheim, California, United States
Gastro SB ClinicRecruiting
Chula Vista, California, United States
United Medical DoctorsRecruiting
Los Alamitos, California, United States
Medical Associates Research Group, Inc.Recruiting
San Diego, California, United States
Peak Gastroenterology AssociatesRecruiting
Colorado Springs, Colorado, United States
Florida Research Center Inc.Recruiting
Lakewood Rch, Florida, United States
Sanchez Clinical Research, IncRecruiting
Miami, Florida, United States
GCP Clinical ResearchRecruiting
Tampa, Florida, United States
Atlanta Gastroenterology SpecialistsRecruiting
Suwanee, Georgia, United States
Tri-State Gastroenterology AssocRecruiting
Crestview Hills, Kentucky, United States
Gastroenterology Clinic of AcadianaRecruiting
Lafayette, Louisiana, United States
Michigan Center of Medical ResearchRecruiting
Farmington Hills, Michigan, United States
New York Gastroenterology AssociatesRecruiting
New York, New York, United States
University of North Carolina HospitalRecruiting
Chapel Hill, North Carolina, United States
Great Lakes Gastroenterology Research, LLCRecruiting
Mentor, Ohio, United States
Digestive Disease Specialists IncRecruiting
Oklahoma City, Oklahoma, United States
The Oregon ClinicRecruiting
Portland, Oregon, United States
Gastro OneRecruiting
Cordova, Tennessee, United States
Tyler Research Institute, LLCRecruiting
Tyler, Texas, United States
GI Alliance TacomaRecruiting
Tacoma, Washington, United States
GEDYTRecruiting
AAI, Argentina
GlobalpsyRecruiting
La Plata, Argentina
HIGEARecruiting
Mendoza, Argentina
Cer Instituto MedicoRecruiting
Quilmes, Argentina
Banksia Trials SARecruiting
Adelaide, Australia
Royal Prince Alfred HospitalRecruiting
Camperdown, Australia
Monash Medical CentreRecruiting
Clayton, Australia
The Melbourne Gut Clinic Epworth HospitalRecruiting
East Melbourne, Australia
IBD SARecruiting
Kurralta Park, Australia
John Hunter HospitalRecruiting
New Lambton Heights, Australia
Mater Misericordiae HospitalRecruiting
South Brisbane, Australia
Universitair Ziekenhuis AntwerpenRecruiting
Edegem, Belgium
Ghent University HospitalRecruiting
Ghent, Belgium
Universitair Ziekenhuis LeuvenRecruiting
Leuven, Belgium
Algemeen Ziekenhuis DeltaRecruiting
Roeselare, Belgium
CDC - Centro Digestivo de CuritibaRecruiting
Curitiba, Brazil
CligedRecruiting
Macaé, Brazil
Hospital De Clinicas De Porto AlegreRecruiting
Porto Alegre, Brazil
Hospital Ernesto DornellesRecruiting
Porto Alegre, Brazil
Pesquisare SaudeRecruiting
Santo André, Brazil
BR TrialsRecruiting
São Paulo, Brazil
Rocco And Nazato Servicos Medicos LtdaRecruiting
São Paulo, Brazil
INTEGRAL Pesquisa e EnsinoRecruiting
Votuporanga, Brazil
South Edmonton Gastroenterology Research ClinicRecruiting
Edmonton, Alberta, Canada
Gastroenterology and Internal Medicine Research Institute (GIRI)Recruiting
Edmonton, Alberta, Canada
GI Research Institute (G.I.R.I.)Recruiting
Vancouver, British Columbia, Canada
Viable Clinical ResearchRecruiting
Kentville, Nova Scotia, Canada
London Digestive Disease InstituteRecruiting
London, Ontario, Canada
West GTA Research IncRecruiting
Mississauga, Ontario, Canada
Toronto Immune and Digestive Health Institute IncRecruiting
Toronto, Ontario, Canada
CHUM - Centre hospitalier universitaire de MontrealRecruiting
Montreal, Quebec, Canada
Clinique IMDRecruiting
Montreal, Quebec, Canada
Peking University Third HospitalRecruiting
Beijing, China
Changzhou No 2 Peoples HospitalRecruiting
Changzhou, China
Chongqing General HospitalRecruiting
Chongqing, China
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal HospitalRecruiting
Guangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of MedicineRecruiting
Hangzhou, China
Huai'an 1st HospitalRecruiting
Huai'an, China
Ningbo medical center lihuili hospitalRecruiting
Ningbo, China
ZhuZhou Central HospitalRecruiting
Zhuzhou, China
Hepato-gastroenterologie HK, s.r.o.Recruiting
Hradec Králové, Czechia
Fakultni Thomayerova nemocniceRecruiting
Prague, Czechia
ISCARE a.s.Recruiting
Prague, Czechia
CHU de Nantes hotel DieuRecruiting
Nantes, France
CHU de ReimsRecruiting
Reims, France
Krankenhaus Waldfriede MitteRecruiting
Berlin, Germany
Universitatsklinikum Carl Gustav Carus DresdenRecruiting
Dresden, Germany
Medizinische Hochschule HannoverRecruiting
Hanover, Germany
Universitatsklinikum Schleswig Holstein KielRecruiting
Kiel, Germany
Eugastro GmbHRecruiting
Leipzig, Germany
Universitaetsklinikum MannheimRecruiting
Mannheim, Germany
Universitaetsmedizin RostockRecruiting
Rostock, Germany
Sushruta Multispecialty Hospital and Research CentreRecruiting
Hubballi, India
Asian Institute Of GastroenterologyRecruiting
Hyderabad, India
S. R. Kalla Memorial General HospitalRecruiting
Jaipur, India
Lisie HospitalRecruiting
Kochi, India
Yashoda Super Speciality HospitalsRecruiting
Secunderabad, India
SIDS (Surat Institute of Digestive Sciences) Hospital and Research CentreRecruiting
Surat, India
Gujarat Gastro and Vascular HospitalRecruiting
Surat, India
Assuta Medical centerRecruiting
Ashdod, Israel
Bnai Zion Medical CenterRecruiting
Haifa, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Wolfson Medical CenterRecruiting
Holon, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
Kfar Saba, Israel
Galilee Medical CenterRecruiting
Nahariya, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Hamamatsu University HospitalRecruiting
Hamamatsu, Japan
National Hospital Organization Hirosaki National HospitalRecruiting
Hirosaki, Japan
Kagoshima IBD Gastroenterology ClinicRecruiting
Kagoshima, Japan
Tsujinaka Hospital KashiwanohaRecruiting
Kashiwa, Japan
Kobe University HospitalRecruiting
Kobe, Japan
Kumamoto University HospitalRecruiting
Kumamoto, Japan
Japanese Red Cross Kumamoto HospitalRecruiting
Kumamoto, Japan
Takano HospitalRecruiting
Kumamoto, Japan
Kitasato University Kitasato Institute HospitalRecruiting
Minatoku, Japan
Nagoya City University HospitalRecruiting
Nagoya, Japan
National Hospital Organization Osaka National HospitalRecruiting
Osaka, Japan
Japanese Red Cross Osaka HospitalRecruiting
Osaka, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General HospitalRecruiting
Sapporo, Japan
Sapporo Higashi Tokushukai HospitalRecruiting
Sapporo, Japan
National Hospital Organization Shizuoka Medical CenterRecruiting
Shimizu, Japan
Takamatsu Red Cross HospitalRecruiting
Takamatsu, Japan
Yamanashi Prefectural Central HospitalRecruiting
Yamanashi, Japan
Hospital AmpangRecruiting
Ampang, Malaysia
Sultan Idris Shah HospitalRecruiting
Kajang, Malaysia
Hospital Queen ElizabethRecruiting
Kota Kinabalu, Malaysia
Hospital Sultanah Nur ZahirahRecruiting
Kuala, Malaysia
University Malaya Medical CentreRecruiting
Petaling Jaya, Malaysia
Radboud UmcnRecruiting
Nijmegen, Netherlands
Alesund sjukehusRecruiting
Ålesund, Norway
Universitetssykehuset Nord-Norge HFRecruiting
Tromsø, Norway
St. Olavs HospitalRecruiting
Trondheim, Norway
Centrum Medyczne Medis ManerMed Sp Z O ORecruiting
Bydgoszcz, Poland
Centrum Medyczne PromedRecruiting
Krakow, Poland
Medrise Sp. z o.o.Recruiting
Lublin, Poland
Centrum Medyczne 'Medyk' Sp. z o.o. K.Recruiting
Rzeszów, Poland
Twoja Przychodnia - Szczecinskie Centrum MedyczneRecruiting
Szczecin, Poland
ETG ZamoscRecruiting
Zamość, Poland
Uls Braga - Hosp. BragaRecruiting
Braga, Portugal
Ulsam - Hosp. Santa LuziaRecruiting
Viana do Castelo, Portugal
FNsP F. D. Roosevelta Banska BystricaRecruiting
Banská Bystrica, Slovakia
Cliniq s.r.o.Recruiting
Bratislava, Slovakia
ENDOMED s.r.oRecruiting
Košice, Slovakia
KM Management spol. s r.o.Recruiting
Nitra, Slovakia
GASTRO I. s.r.o.Recruiting
Prešov, Slovakia
Gastro LM s.r.o.Recruiting
Prešov, Slovakia
Inje University Haeundae Paik HospitalRecruiting
Busan, South Korea
The Catholic University of Korea Daejeon St Mary's HospitalRecruiting
Daejeon, South Korea
Samsung Medical CenterRecruiting
Gangnam Gu, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Hosp. Univ. Infanta LeonorRecruiting
Madrid, Spain
Hosp. Alvaro CunqueiroRecruiting
Vigo, Spain
Linkou Chang Gung Memorial HospitalRecruiting
Taoyuan, Taiwan
Antalya Training And Research HospitalRecruiting
Antalya, Turkey (Türkiye)
Bezmialem University Medical FacultyRecruiting
Istanbul, Turkey (Türkiye)
Marmara University Pendik Training HospitalRecruiting
Istanbul, Turkey (Türkiye)
Izmir Sehir HastanesiRecruiting
Izmir, Turkey (Türkiye)
Kocaeli University Medical FacultyRecruiting
Kocaeli, Turkey (Türkiye)
Mersin University Medical FacultyRecruiting
Mersin, Turkey (Türkiye)