A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting · NCT07577856 · 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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
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
- Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
- Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
- An endoscopy subscore \>=2 as obtained during central review of the screening video endoscopy
- Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies
Exclusion criteria
- Isolated proctitis (UC limited to the rectum only or to less than \[\<\] 20 centimeter \[cm\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
- Has a history of or ongoing chronic or recurrent infectious disease
- Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
- Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention
Where it is running
60 locations listed across 14 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
- 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
- Southern Star Research Institute, LLC - San Antonio, Texas, 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
- Hosp. Gral. Univ. Dr. Balmis - Alicante, Spain
- 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
- Beijing Friendship Hospital Capital Medical University - Beijing, China
- Peking University Third Hospital - Beijing, China
- Krankenhaus Waldfriede Mitte - Berlin, Germany
- Imelda Bonheiden - Bonheiden, Belgium
- Uls Braga - Hosp. Braga - Braga, Portugal
- Cliniq s.r.o. - Bratislava, Slovakia
- AZ Sint-Lucas - Bruges, Belgium
- ULB Erasme Ziekenhuis - Brussels, Belgium
- UZ Brussel - Brussels, Belgium
- Instituto Medico De Alta Complejidad (IMAC) - Buenos Aires, Argentina
- 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
- Samsung Medical Center - Gangnam Gu, South Korea
- Sanko Universitesi Hastanesi - Gaziantep, Turkey (Türkiye)
- AZ Maria Middelares - Ghent, Belgium
- Ghent University Hospital - Ghent, Belgium
- Sykehuset Innlandet HF Gjøvik - Gjøvik, Norway
- The First Affiliated Hospital Sun Yat sen University - Guangzhou, China
- Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital - Guangzhou, China
- Rambam Medical Center - Haifa, Israel
- Bnai Zion Medical Center - Haifa, Israel
- Hamamatsu University Hospital - Hamamatsu, Japan
- Matsuda Hospital - Hamamatsu, Japan
- Medizinische Hochschule Hannover - Hanover, Germany
- Herlev Hospital - Herlev, Denmark
Showing 60 of 170 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →