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 Crohn’s Disease - DUET-CD

Janssen-Cilag International NV0 个研究点目标入组 715 人开始时间: 2022年8月31日最近更新: 2024年6月24日

试验速览

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•Diagnosis of Crohn's disease (CD) for at least 3 months prior to baseline
•Confirmed diagnosis of moderate to severe CD as assessed by Crohn's disease activity index (CDAI), stool frequency (SF), abdominal pain (AP) score and simple endoscopic score for Crohn's disease (SES-CD)
•Demonstrated inadequate response, loss of response, or intolerance to at least one biologic
•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 715
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Complications of CD that may be anticipated to require surgery
•Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
•Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks
•Has a draining (example, functioning) stoma or ostomy
•Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for greater than or equal to (>=)12 months before the first dose of study intervention
•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
•For an overview of all the exclusion criteria please refer to protocol section 5.2

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