A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 33
- 主要终点
- Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
研究概览
简要总结
The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Period 1 is double-blind. Period 2 and Period 3 are open-label.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization
- •Has moderately to severely active UC
- •Has a weight ≥40 kg
- •Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments
- •Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable
排除标准
- •include but are not limited to the following:
- •Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
- •Has a current diagnosis of fulminant colitis and/or toxic megacolon
- •Has UC limited to the rectum
- •Has a current or impending need for colostomy or ileostomy
- •Has had a total proctocolectomy or partial colectomy
- •Has UC exacerbation requiring hospitalization within 2 weeks before Screening
- •Has any active infection as specified in the protocol
- •Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- •Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
- •Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization or has a history of colorectal cancer at any time
- •Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed
- •Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
- •Has received protocol-specified prohibited medications
研究组 & 干预措施
Period 1: Placebo
Participants will receive placebo via subcutaneous injection for 12 weeks.
干预措施: Placebo (Other)
Period 1: MK-8690
Participants will receive MK-8690 via subcutaneous injection for 12 weeks.
干预措施: MK-8690 (Drug)
Period 3: MK-8690
Participants who respond to treatment in either Period 1 or Period 2 will receive additional MK-8690 via subcutaneous injection for up to approximately 42 weeks.
干预措施: MK-8690 (Drug)
Period 2: MK-8690
Participants who do not respond to treatment in Period 1 (regardless of treatment assignment in Period 1) will receive MK-8690 via subcutaneous injection for 12 weeks.
干预措施: MK-8690 (Drug)
结局指标
主要结局
Percentage of Participants Achieving Clinical Remission Per Modified Mayo Score (MMS) at Week 12
时间窗: Week 12
The MMS is a composite score of UC disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1 with no friability, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
次要结局
- Percentage of Participants With One or More Adverse Events (AEs)(Up to approximately 12 months)
- Percentage of Participants Who Discontinued Study Intervention Due to an AE(Up to approximately 12 months)
- Percentage of Participants Achieving Clinical Response Per MMS at Week 12(Week 12)
- Percentage of Participants With Endoscopic Improvement at Week 12(Week 12)
- Percentage of Participants Achieving Clinical Remission Per Partial Modified Mayo Score (pMMS) at Week 12(Week 12)
- Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement (HEMI) at Week 12(Week 12)