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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 82
- 主要终点
- Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
- •Moderately to severely active UC as defined by Mayo score
- •History of inadequate response to or failure to tolerate conventional therapy
- •Has screening laboratory test results within the study protocol defined parameters
- •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
排除标准
- •Has severe extensive colitis as defined in the study protocol
- •Has UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon
- •Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
- •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)
- •Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
研究组 & 干预措施
Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Guselkumab Dose 1 (Drug)
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Placebo (Drug)
Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Guselkumab Dose 2 (Drug)
Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Golimumab Dose 1 (Drug)
Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Golimumab Dose 2 (Drug)
Combination Therapy
Participants will receive guselkumab Dose 1 as intravenous (IV) infusion and Dose 2 as subcutaneous (SC) injection; and golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Placebo (Drug)
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Guselkumab Dose 1 (Drug)
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Guselkumab Dose 2 (Drug)
Monotherapy: Guselkumab
Participants will receive guselkumab Dose 1 as IV infusion, Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Placebo (Drug)
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Golimumab Dose 1 (Drug)
Monotherapy: Golimumab
Participants will receive golimumab Dose 1 and Dose 2 as SC injection and placebo to maintain the blind.
干预措施: Golimumab Dose 2 (Drug)
结局指标
主要结局
Combination Phase: Percentage of Participants Who Achieved Clinical Response at Week 12
时间窗: Week 12
Clinical response was defined as a decrease from baseline in the Mayo score greater than or equal to (\>=) 30 percent (%) and \>=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) \>=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Higher scores indicate more severity. This outcome measure was analyzed for combination phase only as preplanned in the protocol.
次要结局
- Combination Phase: Percentage of Participants Who Achieved Clinical Remission at Week 12(Week 12)