A Phase II, Multicenter Induction Study With an Active Treatment Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Patients With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 65
- 主要终点
- Percentage of Participants With Clinical Remission at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of response to, or intolerance to prior conventional or advanced therapy.
详细描述
This study consists of two periods:
- An induction period which will test the induction of clinical remission;
- An optional active treatment extension (ATE) period which will explore durability of clinical response and remission in which all participants will receive vixarelimab.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC for at least 3 months
- •Moderately to severely active UC, assessed by mMS
- •Inadequate response, loss of response to, or intolerance to conventional or advanced therapies for UC
排除标准
- •Diagnosis of Crohn's disease or indeterminate colitis
- •Suspicion of ischemic, radiation, microscopic, or infectious colitis
- •Prior colectomy
- •Inadequate response or loss of response to previous treatment of UC with tofacitinib, upadacitinib, or other systemic janus kinase (JAK) inhibitor
研究组 & 干预措施
Vixarelimab Dose Regimen 1
Participants will receive vixarelimab subcutaneously (SC) during the induction period and the optional ATE period.
干预措施: Vixarelimab (Drug)
Vixarelimab Dose Regimen 2
Participants will receive vixarelimab SC during the induction period and the optional ATE period.
干预措施: Vixarelimab (Drug)
Placebo
Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.
干预措施: Vixarelimab (Drug)
Placebo
Participants will receive placebo SC during the induction period and vixarelimab SC during the optional ATE period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Remission at Week 12
时间窗: At Week 12
Clinical remission was defined as modified Mayo Score (mMS) of ≤ 2, including stool frequency subscore ≤ 1, rectal bleeding subscore=0, \& endoscopy subscore ≤ 1 (score of 1 modified to exclude friability). MMS is a composite of 3 Mayo Score assessments, each scored on a scale from 0-3. The total score ranges from 0-9, with higher scores indicating more severe disease: stool frequency (0=Normal number of stools, 1=1-2 more stools than normal, 2=3-4 more stools than normal, 3=5 or more stools than normal); rectal bleeding (0=No blood seen or no bowel movement, 1=Stool with streaks of blood, 2=Stool with more than streaks of blood, 3=Blood alone passed); centrally read endoscopy (0=Normal appearance of mucosa, 1=Mild disease \[erythema, decreased vascular pattern\], 2=Moderate disease \[marked erythema, absent vascular pattern, friability, erosions\], 3=Severe disease \[spontaneous bleeding, ulceration\]). Percentages have been rounded off.
次要结局
- Percentage of Participants With Endoscopic Improvement at Week 12(At Week 12)
- Percentage of Participants With Endoscopic Remission at Week 12(At Week 12)
- Number of Participants With Adverse Events (AEs)(Induction period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 22 weeks); ATE period: From treatment initiation up to 10 weeks follow-up after the final dose (up to 56 weeks))
- Serum Concentration of Vixarelimab at Specified Timepoints(Weeks 0, 1, 2, 4, 8, 12, and study completion/early termination (up to 22 weeks))
- Induction: Number of Participants With Anti-drug Antibodies (ADAs)(Baseline and post-baseline visits (up to 12 weeks))
- Percentage of Participants With Clinical Response at Week 12(At Week 12)