A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC

Janssen-Cilag International NV0 个研究点目标入组 550 人开始时间: 2022年12月27日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline
•Moderately to severely active UC as assessed by the modified mayo score
•Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity
•If female and of childbearing potential, must meet the contraception and reproduction requirements
•For an overview of all the inclusion criteria please refer to protocol section 5.1
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 550
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Has severe extensive colitis as defined in the protocol
•Extent of inflammatory disease limited to the rectum
•Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)
•Has a history of, or ongoing, chronic or recurrent infectious disease
•Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
•For an overview of all the exclusion criteria please refer to protocol section 5.2

发起方