Last updated 5 days ago
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
644 patients around the world
Available in United States, Brazil
Janssen Research & Development, LLC
2Research sites
644Patients around the world
This study is for people with
Ulcerative colitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Pesquisare Saude
Recruiting
BR Trials - Pesquisa Clínica - Sao Paulo
Recruiting
StudyDUET ENCORE-UC
SponsorJanssen Research & Development, LLC
Study typeInterventional
Conditions
Ulcerative colitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07577856
