2022-501119-14-01招募中2 期
A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 37
- 主要终点
- Clinical Response, defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score (MCS), Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1 at Week 12
研究概览
简要总结
To demonstrate the efficacy of GS-5290, compared to placebo control, in achieving Clinical Response at Week 12
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants assigned male at birth, or nonpregnant, nonlactating participants assigned female at birth, 18 to 75 years of age based on the date of the screening visit.
- •UC of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
- •Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).
- •Previous treatment history of approved UC therapy with at least one of the following advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action.
- •Documentation of a surveillance colonoscopy in the 24 months prior to screening in participants who have a history of UC for 8 or more years. Note: other protocol-defined inclusion criteria may apply.
排除标准
- •Current diagnosis of CD or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
- •Participants with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.
- •Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 5.6.2
- •Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.
- •History of opportunistic infection.
- •Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon. Note: other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Clinical Response, defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score (MCS), Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1 at Week 12
Clinical Response, defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score (MCS), Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1 at Week 12
次要结局
- Clinical Remission, defined as a Stool Frequency subscore ≤ 1 and not greater than baseline, Rectal Bleeding subscore of 0, and Endoscopic Findings subscore ≤ 1 at Week 12
- Endoscopic Response, defined as an Endoscopic Findings subscore ≤ 1 at Week 12
- Histologic Endoscopic Mucosal Improvement, defined as an Endoscopic Findings subscore ≤ 1 and Geboes score < 3.1 (indicating neutrophil infiltration in < 5% of crypts, no crypt destruction and no erosions, ulcerations, or granulation tissue) at Week 12
研究者
EU Clinical Trials Support
Scientific
Gilead Sciences Inc.
研究点 (37)
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