A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

NCT07577843 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 78934804CRD3001
• Study Type: interventional
• Target: 460
• Locations: 23 countries
• Sites: 142

Brief Summary

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).

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• Co-Primary: Percentage of Participants with Clinical Remission at Week 48

  Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

  At Week 48

• Co-Primary: Percentage of Participants with Endoscopic Remission at Week 48

  Endoscopic remission is defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of less than or equal to (\<=) 4 with at least a 2-point reduction from baseline and no subscore greater than (\>) 1 in any individual component. The SES-CD is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

  At Week 48

Secondary Outcomes (10)

• Percentage of Participants with Deep Remission at Week 48

  At Week 48

• Percentage of Participants with Corticosteroid-Free (90-Day) Clinical Remission at Week 48

  At Week 48

• Percentage of Participants with Corticosteroid-Free (90-day) PRO-2 Remission at Week 48

  At Week 48

• Percentage of Participants with Sustained Clinical Remission

  At Weeks 12 and 48

• Percentage of Participants with Histologic-Endoscopic Remission at Week 48

  At Week 48

Study Arms (2)

JNJ-78934804

EXPERIMENTAL

Participants will receive JNJ-78934804 induction dose, at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.

Drug: JNJ-78934804

Guselkumab

ACTIVE COMPARATOR

Participants will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.

Drug: JNJ-78934804; Drug: Guselkumab

Interventions

JNJ-78934804 DRUG

JNJ-78934804 will be administered subcutaneously.

Also known as: JNJ-4804

Guselkumab; JNJ-78934804

Guselkumab DRUG

Guselkumab will be administered subcutaneously.

Also known as: TREMFYA

Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (142)

Clinnova Research

Anaheim, California, 92805, United States

RECRUITING

Gastro SB Clinic

Chula Vista, California, 91910, United States

RECRUITING

United Medical Doctors

Los Alamitos, California, 90720, United States

RECRUITING

Medical Associates Research Group, Inc.

San Diego, California, 92123, United States

RECRUITING

Peak Gastroenterology Associates

Colorado Springs, Colorado, 80907, United States

RECRUITING

Florida Research Center Inc.

Lakewood Rch, Florida, 34211, United States

RECRUITING

Sanchez Clinical Research, Inc

Miami, Florida, 33157-6575, United States

RECRUITING

GCP Clinical Research

Tampa, Florida, 33609, United States

RECRUITING

Atlanta Gastroenterology Specialists

Suwanee, Georgia, 30024, United States

RECRUITING

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, 41017, United States

RECRUITING

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, 70503, United States

RECRUITING

Michigan Center of Medical Research

Farmington Hills, Michigan, 48334, United States

RECRUITING

New York Gastroenterology Associates

New York, New York, 10075, United States

RECRUITING

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

RECRUITING

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma, 73114, United States

RECRUITING

The Oregon Clinic

Portland, Oregon, 97220, United States

RECRUITING

Gastro One

Cordova, Tennessee, 38018, United States

RECRUITING

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

RECRUITING

GI Alliance Tacoma

Tacoma, Washington, 98405, United States

RECRUITING

GEDYT

AAI, C1425BGC, Argentina

RECRUITING

Globalpsy

La Plata, 1896, Argentina

RECRUITING

HIGEA

Mendoza, M5500DPS, Argentina

RECRUITING

Cer Instituto Medico

Quilmes, B1878DVB, Argentina

RECRUITING

Banksia Trials SA

Adelaide, 5000, Australia

RECRUITING

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

RECRUITING

Monash Medical Centre

Clayton, 3168, Australia

RECRUITING

The Melbourne Gut Clinic Epworth Hospital

East Melbourne, 3002, Australia

RECRUITING

IBD SA

Kurralta Park, 5037, Australia

RECRUITING

John Hunter Hospital

New Lambton Heights, 2305, Australia

RECRUITING

Mater Misericordiae Hospital

South Brisbane, 4101, Australia

RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

Ghent University Hospital

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

RECRUITING

Algemeen Ziekenhuis Delta

Roeselare, 8800, Belgium

RECRUITING

CDC - Centro Digestivo de Curitiba

Curitiba, 80430 180, Brazil

RECRUITING

Cliged

Macaé, 27910-020, Brazil

RECRUITING

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035 903, Brazil

RECRUITING

Hospital Ernesto Dornelles

Porto Alegre, 90160 093, Brazil

RECRUITING

Pesquisare Saude

Santo André, 09080-110, Brazil

RECRUITING

BR Trials

São Paulo, 01236 030, Brazil

RECRUITING

Rocco And Nazato Servicos Medicos Ltda

São Paulo, 04077-020, Brazil

RECRUITING

INTEGRAL Pesquisa e Ensino

Votuporanga, 15500-269, Brazil

RECRUITING

South Edmonton Gastroenterology Research Clinic

Edmonton, Alberta, Code: T6K 4B2, Canada

RECRUITING

Gastroenterology and Internal Medicine Research Institute (GIRI)

Edmonton, Alberta, T5R 1W2, Canada

RECRUITING

GI Research Institute (G.I.R.I.)

Vancouver, British Columbia, V6Z 2K5, Canada

RECRUITING

Viable Clinical Research

Kentville, Nova Scotia, B4N 0A3, Canada

RECRUITING

London Digestive Disease Institute

London, Ontario, N6K 1M6, Canada

RECRUITING

West GTA Research Inc

Mississauga, Ontario, L5M 2S4, Canada

RECRUITING

Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario, M6A 3B4, Canada

RECRUITING

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Clinique IMD

Montreal, Quebec, H3H1E3, Canada

RECRUITING

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

Changzhou No 2 Peoples Hospital

Changzhou, 213004, China

RECRUITING

Chongqing General Hospital

Chongqing, 400014, China

RECRUITING

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

Guangzhou, 510655, China

RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310000, China

RECRUITING

Huai'an 1st Hospital

Huai'an, 223300, China

RECRUITING

Ningbo medical center lihuili hospital

Ningbo, 315041, China

RECRUITING

ZhuZhou Central Hospital

Zhuzhou, 412007, China

RECRUITING

Hepato-gastroenterologie HK, s.r.o.

Hradec Králové, 500 12, Czechia

RECRUITING

Fakultni Thomayerova nemocnice

Prague, 14000, Czechia

RECRUITING

ISCARE a.s.

Prague, 190 00, Czechia

RECRUITING

CHU de Nantes hotel Dieu

Nantes, 44000, France

RECRUITING

CHU de Reims

Reims, 51100, France

RECRUITING

Krankenhaus Waldfriede Mitte

Berlin, 14163, Germany

RECRUITING

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitatsklinikum Schleswig Holstein Kiel

Kiel, 24105, Germany

RECRUITING

Eugastro GmbH

Leipzig, 04103, Germany

RECRUITING

Universitaetsklinikum Mannheim

Mannheim, 68167, Germany

RECRUITING

Universitaetsmedizin Rostock

Rostock, 18057, Germany

RECRUITING

Sushruta Multispecialty Hospital and Research Centre

Hubballi, 580021, India

RECRUITING

Asian Institute Of Gastroenterology

Hyderabad, 500032, India

RECRUITING

S. R. Kalla Memorial General Hospital

Jaipur, 302006, India

RECRUITING

Lisie Hospital

Kochi, 682018, India

RECRUITING

Yashoda Super Speciality Hospitals

Secunderabad, 500003, India

RECRUITING

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

Surat, 395002, India

RECRUITING

Gujarat Gastro and Vascular Hospital

Surat, 395009, India

RECRUITING

Assuta Medical center

Ashdod, 7747629, Israel

RECRUITING

Bnai Zion Medical Center

Haifa, 31048, Israel

RECRUITING

Rambam Medical Center

Haifa, 3109601, Israel

RECRUITING

Wolfson Medical Center

Holon, 5822012, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

Meir Medical Center

Kfar Saba, 44281, Israel

RECRUITING

Galilee Medical Center

Nahariya, 2210001, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Hamamatsu University Hospital

Hamamatsu, 431-3192, Japan

RECRUITING

National Hospital Organization Hirosaki National Hospital

Hirosaki, 036-8545, Japan

RECRUITING

Kagoshima IBD Gastroenterology Clinic

Kagoshima, 892-0843, Japan

RECRUITING

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871, Japan

RECRUITING

Kobe University Hospital

Kobe, 650 0017, Japan

RECRUITING

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

RECRUITING

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520, Japan

RECRUITING

Takano Hospital

Kumamoto, 862-0971, Japan

RECRUITING

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642, Japan

RECRUITING

Nagoya City University Hospital

Nagoya, 467-8602, Japan

RECRUITING

National Hospital Organization Osaka National Hospital

Osaka, 540-0006, Japan

RECRUITING

Japanese Red Cross Osaka Hospital

Osaka, 543-8555, Japan

RECRUITING

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

Sapporo, 060-0033, Japan

RECRUITING

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033, Japan

RECRUITING

National Hospital Organization Shizuoka Medical Center

Shimizu, 411-8611, Japan

RECRUITING

Takamatsu Red Cross Hospital

Takamatsu, 760-0017, Japan

RECRUITING

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506, Japan

RECRUITING

Hospital Ampang

Ampang, 68000, Malaysia

RECRUITING

Sultan Idris Shah Hospital

Kajang, 43000, Malaysia

RECRUITING

Hospital Queen Elizabeth

Kota Kinabalu, 88586, Malaysia

RECRUITING

Hospital Sultanah Nur Zahirah

Kuala, 20400, Malaysia

RECRUITING

University Malaya Medical Centre

Petaling Jaya, 50603, Malaysia

RECRUITING

Radboud Umcn

Nijmegen, 6525 GA, Netherlands

RECRUITING

Alesund sjukehus

Ålesund, 6017, Norway

RECRUITING

Universitetssykehuset Nord-Norge HF

Tromsø, 9038, Norway

RECRUITING

St. Olavs Hospital

Trondheim, 7030, Norway

RECRUITING

Centrum Medyczne Medis ManerMed Sp Z O O

Bydgoszcz, 85 229, Poland

RECRUITING

Centrum Medyczne Promed

Krakow, 31-513, Poland

RECRUITING

Medrise Sp. z o.o.

Lublin, 20 582, Poland

RECRUITING

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

Rzeszów, 35-055, Poland

RECRUITING

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, 71-434, Poland

RECRUITING

ETG Zamosc

Zamość, 22 400, Poland

RECRUITING

Uls Braga - Hosp. Braga

Braga, 4710 243, Portugal

RECRUITING

Ulsam - Hosp. Santa Luzia

Viana do Castelo, 4900-408, Portugal

RECRUITING

FNsP F. D. Roosevelta Banska Bystrica

Banská Bystrica, 975 17, Slovakia

RECRUITING

Cliniq s.r.o.

Bratislava, 811 09, Slovakia

RECRUITING

ENDOMED s.r.o

Košice, 040 13, Slovakia

RECRUITING

KM Management spol. s r.o.

Nitra, 949 01, Slovakia

RECRUITING

GASTRO I. s.r.o.

Prešov, 080 01, Slovakia

RECRUITING

Gastro LM s.r.o.

Prešov, 080 01, Slovakia

RECRUITING

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

RECRUITING

The Catholic University of Korea Daejeon St Mary's Hospital

Daejeon, 34943, South Korea

RECRUITING

Samsung Medical Center

Gangnam Gu, 06351, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain

RECRUITING

Hosp. Alvaro Cunqueiro

Vigo, 36312, Spain

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

RECRUITING

Antalya Training And Research Hospital

Antalya, 07100, Turkey (Türkiye)

RECRUITING

Bezmialem University Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

Marmara University Pendik Training Hospital

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Izmir Sehir Hastanesi

Izmir, 35540, Turkey (Türkiye)

RECRUITING

Kocaeli University Medical Faculty

Kocaeli, 41001, Turkey (Türkiye)

RECRUITING

Mersin University Medical Faculty

Mersin, 33343, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): June 12, 2028
• Study Completion (Estimated): July 12, 2030
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (8); TW (1); MY (5); CA (9); AU (7); IL (10); TU (6); SL (6); DE (7); FR (2); IN (7); KR (4); BE (4); CN (8); AR (4); CZ (3); NL (1); NO (3); PT (2); ES (2); PL (6); US (20); JP (17)