A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- GB004, Inc.
- 入组人数
- 236
- 试验地点
- 77
- 主要终点
- Percentage of Participants With Clinical Remission at PCP Week 12
研究概览
简要总结
A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.
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
Subjects, investigators and site personnel, and the Sponsor will be blinded to individual subject treatment assignments.
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
- •Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
- •UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day
- •Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:
- •prednisone ≤ 20 mg/day or equivalent or
- •beclomethasone ≤ 5 mg/day or
- •budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day
排除标准
- •Prior approved biologic therapy used for the treatment of UC.
- •Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
- •Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day
- •Azathioprine, or 6-mercaptopurine within 1 day of Day
- •NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
研究组 & 干预措施
PCP Placebo
PCP Placebo for oral administration for 36 weeks
干预措施: Placebo (Drug)
PCP GB004 480 mg QD
PCP GB004 480 mg QD for oral administration for 36 weeks
干预措施: GB004 (Drug)
PCP GB004 480 mg BID
PCP GB004 480 mg BID for oral administration for 36 weeks
干预措施: GB004 (Drug)
Open-Label Extension (OLE) GB004 480 mg BID
OLE GB004 480 mg BID for oral administration for 24 weeks
干预措施: GB004 (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Remission at PCP Week 12
时间窗: At PCP Week 12
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Percentage of Participants With a Treatment Emergent Adverse Event
时间窗: From first dose of OLE study treatment through OLE Week 28
An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs. An AE was considered treatment-emergent to the OLE if it started on or after the first dose of OLE study treatment.
次要结局
- Percentage of Participants With Clinical Response at PCP Week 12(At PCP Week 12)
- Percentage of Participants With Histologic Remission at PCP Week 12(At PCP Week 12)
- Percentage of Participants With Endoscopic Improvement at PCP Week 12(At PCP Week 12)
- Percentage of Participants With Clinical Response at PCP Week 36(At PCP Week 36)
- Percentage of Participants With Histologic Remission at PCP Week 36(At PCP Week 36)
- Percentage of Participants With Mucosal Healing at PCP Week 36(At PCP Week 36)
- Percentage of Participants With Mucosal Healing at PCP Week 12(At PCP Week 12)
- Percentage of Participants With Clinical Remission at PCP Week 36(At PCP Week 36)
- Percentage of Participants With Endoscopic Improvement at PCP Week 36(At PCP Week 36)