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 Pharmaceutical K.K.0 个研究点目标入组 550 人开始时间: 2023年5月10日最近更新: 2025年2月17日

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

•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, including but not limited to, sinopulmonary infections, bronchiectasis, recurrent renal/urinary tract infections (example, pyelonephritis, cystitis), an open, draining, or infected skin wound, or an ulcer
•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)

Percentage of Participants with Clinical Remission at Week 48

时间窗: Week 48

Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.

Percentage of Participants with Endoscopic Improvement at Week 48(Week 48)
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 48(Week 48)
Percentage of Participants with Symptomatic Remission at Week 48(Week 48)
Percentage of Participants with Combination of Histological Remission and Endoscopic Improvement at Week 48(Week 48)
Percentage of Participants with Adverse Events (AEs)(Up to Week 48)
Percentage of Participants with Clinical Remission at Week 48(Week 48)
Serum Concentrations of Guselkumab Over Time(Up to Week 48)
Serum Concentrations of Golimumab Over Time(Up to Week 48)
Percentage of Participants with Antibodies to Guselkumab(Up to Week 48)
Titers of Antibodies to Guselkumab(Up to Week 48)
Percentage of Participants with Antibodies to Golimumab(Up to Week 48)
Percentage of Participants with Serious Adverse Events (SAEs)(Up to Week 48)
Laboratory Parameters Over Time(Up to Week 48)
Vital Signs Parameters Over Time(Up to Week 48)
Suicidal Ideation Assessment Using Columbia Suicide Severity Rating Scale (C-SSRS) Score(Up to Week 48)
Titers of Antibodies to Golimumab(Up to Week 48)
Percentage of Participants with Neutralizing Antibodies to Guselkumab(Up to Week 48)
Percentage of Participants with Neutralizing Antibodies to Golimumab(Up to Week 48)

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