A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative ColitisPhase 3 Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants with Moderately to Severely Active Ulcerative Colitis - ASTRO

Johnson and Johnson Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•Documented 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
•-Demonstraed inadequate response to or intolerance of conventional (ie,6-MP, AZA, or corticosteroids) or advanced therapy (ADT; ie, TNFa antagonists, vedolizumab, ozanimod, or approved JAK inhibitors).

•-Extent of inflammatory disease limited to the rectum
•-Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohns 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)
•-Has severe extensive colitis as defined in the protocol

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