A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
Recruiting · NCT07577843 · Interventional (participants receive a specific treatment) · Lead sponsor: Janssen Research & Development, LLC
View the official record on ClinicalTrials.gov →Interventions studied
GuselkumabJNJ-78934804
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 15 US states.
- Clinnova Research - Anaheim, California, United States
- Gastro SB Clinic - Chula Vista, California, United States
- United Medical Doctors - Los Alamitos, California, United States
- Medical Associates Research Group, Inc. - San Diego, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- Florida Research Center Inc. - Lakewood Rch, Florida, United States
- Sanchez Clinical Research, Inc - Miami, Florida, United States
- GCP Clinical Research - Tampa, Florida, United States
- Atlanta Gastroenterology Specialists - Suwanee, Georgia, United States
- Tri-State Gastroenterology Assoc - Crestview Hills, Kentucky, United States
- Gastroenterology Clinic of Acadiana - Lafayette, Louisiana, United States
- Michigan Center of Medical Research - Farmington Hills, Michigan, United States
- New York Gastroenterology Associates - New York, New York, United States
- University of North Carolina Hospital - Chapel Hill, North Carolina, United States
- Great Lakes Gastroenterology Research, LLC - Mentor, Ohio, United States
- Digestive Disease Specialists Inc - Oklahoma City, Oklahoma, United States
- The Oregon Clinic - Portland, Oregon, United States
- Gastro One - Cordova, Tennessee, United States
- Tyler Research Institute, LLC - Tyler, Texas, United States
- GI Alliance Tacoma - Tacoma, Washington, United States
- GEDYT - AAI, Argentina
- Banksia Trials SA - Adelaide, Australia
- Hospital Ampang - Ampang, Malaysia
- Antalya Training And Research Hospital - Antalya, Turkey (Türkiye)
- Assuta Medical center - Ashdod, Israel
- FNsP F. D. Roosevelta Banska Bystrica - Banská Bystrica, Slovakia
- Peking University Third Hospital - Beijing, China
- Krankenhaus Waldfriede Mitte - Berlin, Germany
- Uls Braga - Hosp. Braga - Braga, Portugal
- Cliniq s.r.o. - Bratislava, Slovakia
- Inje University Haeundae Paik Hospital - Busan, South Korea
- Centrum Medyczne Medis ManerMed Sp Z O O - Bydgoszcz, Poland
- Royal Prince Alfred Hospital - Camperdown, Australia
- Changzhou No 2 Peoples Hospital - Changzhou, China
- Chongqing General Hospital - Chongqing, China
- Monash Medical Centre - Clayton, Australia
- CDC - Centro Digestivo de Curitiba - Curitiba, Brazil
- The Catholic University of Korea Daejeon St Mary's Hospital - Daejeon, South Korea
- Universitatsklinikum Carl Gustav Carus Dresden - Dresden, Germany
- The Melbourne Gut Clinic Epworth Hospital - East Melbourne, Australia
- Universitair Ziekenhuis Antwerpen - Edegem, Belgium
- Samsung Medical Center - Gangnam Gu, South Korea
- Ghent University Hospital - Ghent, Belgium
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital - Guangzhou, China
- Bnai Zion Medical Center - Haifa, Israel
- Rambam Medical Center - Haifa, Israel
- Hamamatsu University Hospital - Hamamatsu, Japan
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou, China
- Medizinische Hochschule Hannover - Hanover, Germany
- National Hospital Organization Hirosaki National Hospital - Hirosaki, Japan
- Wolfson Medical Center - Holon, Israel
- Hepato-gastroenterologie HK, s.r.o. - Hradec Králové, Czechia
- Huai'an 1st Hospital - Huai'an, China
- Sushruta Multispecialty Hospital and Research Centre - Hubballi, India
- Asian Institute Of Gastroenterology - Hyderabad, India
- Bezmialem University Medical Faculty - Istanbul, Turkey (Türkiye)
- Marmara University Pendik Training Hospital - Istanbul, Turkey (Türkiye)
- Izmir Sehir Hastanesi - Izmir, Turkey (Türkiye)
- S. R. Kalla Memorial General Hospital - Jaipur, India
- Shaare Zedek Medical Center - Jerusalem, Israel
Showing 60 of 142 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →