A Phase 3 Randomized, Double-blind, and Active controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis (DUET ENCORE-UC)

未提供0 个研究点目标入组 644 人开始时间: 待定

适应症

试验速览

暂无简介。

•At the time of informed consent, must be greater than or equal to (>=) 18 years of age
•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

发起方

未提供