EUCTR2018-001510-15-PL进行中（未招募）1 期
A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
- •2. Moderately to severely active UC as defined by Mayo score
- •3. History of inadequate response to or failure to tolerate conventional therapy
- •4. Has screening laboratory test results within the study protocol defined parameters
- •5. A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin pregnancy test result at screening and a negative urine pregnancy test result at Week 0
- •For all inclusion criteria, please refer to section 5.1 in the protocol
- •amendment 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 210
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Has severe extensive colitis as defined in the study protocol
- •2. Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
- •3. Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
- •4. Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
- •5. Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
- •For all exclusion criteria, please refer to section 5.2 in the protocol
- •amendment 1
研究者
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