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: 9 countries
• Sites: 55

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 (55)

Clinnova Research

Anaheim, California, 92805, United States

RECRUITING

Gastro SB Clinic

Chula Vista, California, 91910, 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

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

Michigan Center of Medical Research

Farmington Hills, Michigan, 48334, United States

RECRUITING

New York Gastroenterology Associates

New York, New York, 10075, 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

Banksia Trials SA

Adelaide, 5000, Australia

RECRUITING

IBD SA

Kurralta Park, 5037, Australia

RECRUITING

Mater Misericordiae Hospital

South Brisbane, 4101, Australia

RECRUITING

BR Trials

São Paulo, 01236 030, Brazil

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

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

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

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

National Hospital Organization Shizuoka Medical Center

Shimizu, 411-8611, Japan

RECRUITING

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506, Japan

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

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: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

MY (3); BR (1); TW (1); JP (13); US (12); CA (6); AU (3); IL (10); TU (6)