2025-522001-38-00招募中2 期
A Phase 2, Multi-Center, Platform Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics with Multiple Therapies in Participants with Active Crohn’s Disease or Active Ulcerative Colitis (ASCEND-IBD)
Mirador Therapeutics Inc.37 个研究点 分布在 8 个国家目标入组 54 人开始时间: 2025年10月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 37
- 主要终点
- Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
研究概览
简要总结
Evaluate safety and tolerability following Induction Phase (IP); Prospective Observer-Blinded Endpoint ISAs: Assess the proportion of participants with endoscopic response (CD) or endoscopic improvement (UC) at end of IP; Randomized Placebo-Controlled ISAs: Assess the proportion of participants with clinical remission at end of IP.
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
- •≥ 18 to ≤ 80 years old.
- •UC: Moderately to severely active UC.
- •UC: Participants must meet drug stabilization requirements.
- •Able to provide written informed consent and understand and comply with the requirements of the study specified both in the Master Protocol and the ISA.
- •Participants must have had insufficient response and/or intolerance to corticosteroid, immunosuppressants, and/or an approved advanced therapy for UC or CD.
- •Female participants must be of non-childbearing potential or have a negative serum pregnancy test at time of Screening if of childbearing potential. Additional requirements for birth control methods apply for each ISA.
- •CD: Documented diagnosis of CD.
- •CD: Moderately to severely active CD as defined by CDAI.
- •CD: SES-CD (per central reading) consistent with moderate to severely active CD.
- •CD: Participants must meet drug stabilization requirements.
- •UC: Documented diagnosis of UC.
排除标准
- •Women who are pregnant or breastfeeding.
- •Participants with any serious bacterial infection within 3 months of Screening.
- •Positive stool PCR or culture for enteric pathogens.
- •Stool positive for Clostridioides difficile (C. difficile) toxin.
- •Clinically significantly abnormal laboratory values.
- •Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.
- •Legal or mental incapacitation, or inability to understand and comply with the requirements of the study.
- •Allergy to intervention or any of the excipients.
- •CD patients: Diagnosis of indeterminate colitis.
- •CD patients: Suspected or diagnosed intra-abdominal or perianal abscess at Screening.
- •CD patients: Current stoma or impending need for ostomy or participants with ileo-anal pouch.
- •Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.
- •CD patients: Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments.
- •CD patients: CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.
- •UC patients: Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation.
- •UC patients: Previous total proctocolectomy or subtotal colectomy.
- •Past or current evidence of definite low-grade or high-grade colonic dysplasia that has not been completely removed.
- •Participants who are scheduled or anticipate the need for surgery, aside from dermatologic or other minor outpatient procedures.
- •Participants who have a known history of clinically significant drug or alcohol abuse, in the opinion of the Investigator.
- •Current symptoms of severe, progressive, or uncontrolled system disease. Concomitant medical conditions that, in the opinion of the Investigator, might place the participant at unacceptable risk for participation in this study.
- •Participants with concomitant primary sclerosing cholangitis.
- •Participants with a history of cancer within the 5 years prior to Screening (other than non-melanoma skin cell cancers cured by local resection).
- •Participants at risk for tuberculosis (TB).
结局指标
主要结局
Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values
Prospective Observer-Blinded Endpoint ISAs: CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase
Prospective Observer-Blinded Endpoint ISAs: CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase
Randomized Placebo-Controlled ISAs: Proportion of participants with clinical remission at end of Induction Phase
Randomized Placebo-Controlled ISAs: Proportion of participants with clinical remission at end of Induction Phase
次要结局
- Proportion of participants with clinical remission at end of Induction Phase
- CD: Change in Global Histopathology Activity Score (GHAS) and RHI from Day 1 to end of Induction Phase UC: Change in Geboes score, RHI, and Nancy Histology Index (NHI) from Day 1 to end of Induction Phase
- CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase
- Proportion of participants with Patient-Reported Outcome-2 (PRO-2) remission at end of Induction Phase
- Proportion of participants with clinical response at end of Induction Phase
- CD: Proportion of participants with endoscopic and clinical response at end of Induction Phase
- UC: Proportion of participants with histologic response at end of Induction Phase
- UC: Proportion of participants with histologic remission at end of Induction Phase
- UC: Proportion of participants with histologic-endoscopic mucosal improvement at end of Induction Phase
- CD: Change in SES-CD from Day 1 to end of Induction Phase UC: Change in MES from Day 1 to end of Induction Phase
- Descriptive summaries of PK of investigational drug
研究者
Mirador Clinical Trials
Scientific
Mirador Therapeutics Inc.
研究点 (37)
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