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NCT07577843PHASE3Recruiting

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

Janssen Research & Development, LLC

Start Date

5/22/2026

Completion Date

7/12/2030

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

JNJ-78934804

DRUG

Guselkumab

Interested in This Trial?

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Conditions

Crohn Disease

Locations

Clinnova Research

Anaheim, California 92805

United States

Gastro SB Clinic

Chula Vista, California 91910

United States

Medical Associates Research Group, Inc.

San Diego, California 92123

United States

Peak Gastroenterology Associates

Colorado Springs, Colorado 80907

United States

Sanchez Clinical Research, Inc

Miami, Florida 33157-6575

United States

GCP Clinical Research

Tampa, Florida 33609

United States

Atlanta Gastroenterology Specialists

Suwanee, Georgia 30024

United States

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky 41017

United States

Michigan Center of Medical Research

Farmington Hills, Michigan 48334

United States

New York Gastroenterology Associates

New York, New York 10075

United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio 44060

United States

Digestive Disease Specialists Inc

Oklahoma City, Oklahoma 73114

United States

Banksia Trials SA

Adelaide, 5000

Australia

IBD SA

Kurralta Park, 5037

Australia

Mater Misericordiae Hospital

South Brisbane, 4101

Australia

BR Trials

São Paulo, 01236 030

Brazil

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

Vancouver, British Columbia V6Z 2K5

Canada

Viable Clinical Research

Kentville, Nova Scotia B4N 0A3

Canada

London Digestive Disease Institute

London, Ontario N6K 1M6

Canada

West GTA Research Inc

Mississauga, Ontario L5M 2S4

Canada

Toronto Immune and Digestive Health Institute Inc

Toronto, Ontario M6A 3B4

Canada

CHUM - Centre hospitalier universitaire de Montreal

Montreal, Quebec H2X 0C1

Canada

Assuta Medical center

Ashdod, 7747629

Israel

Bnai Zion Medical Center

Haifa, 31048

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Wolfson Medical Center

Holon, 5822012

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Meir Medical Center

Kfar Saba, 44281

Israel

Galilee Medical Center

Nahariya, 2210001

Israel

Rabin Medical Center

Petah Tikva, 4941492

Israel

Sheba Medical Center

Ramat Gan, 52621

Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239

Israel

National Hospital Organization Hirosaki National Hospital

Hirosaki, 036-8545

Japan

Kagoshima IBD Gastroenterology Clinic

Kagoshima, 892-0843

Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871

Japan

Kobe University Hospital

Kobe, 650 0017

Japan

Kumamoto University Hospital

Kumamoto, 860-8556

Japan

Japanese Red Cross Kumamoto Hospital

Kumamoto, 861-8520

Japan

Takano Hospital

Kumamoto, 862-0971

Japan

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642

Japan

National Hospital Organization Osaka National Hospital

Osaka, 540-0006

Japan

Japanese Red Cross Osaka Hospital

Osaka, 543-8555

Japan

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

Sapporo, 060-0033

Japan

National Hospital Organization Shizuoka Medical Center

Shimizu, 411-8611

Japan

Yamanashi Prefectural Central Hospital

Yamanashi, 400-8506

Japan

Sultan Idris Shah Hospital

Kajang, 43000

Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, 88586

Malaysia

Hospital Sultanah Nur Zahirah

Kuala, 20400

Malaysia

Linkou Chang Gung Memorial Hospital

Taoyuan, 333

Taiwan

Antalya Training And Research Hospital

Antalya, 07100

Turkey (Türkiye)

Bezmialem University Medical Faculty

Istanbul, 34093

Turkey (Türkiye)

Marmara University Pendik Training Hospital

Istanbul, 34899

Turkey (Türkiye)

Izmir Sehir Hastanesi

Izmir, 35540

Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, 41001

Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, 33343

Turkey (Türkiye)