A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of IPG11406 Tablets in Adult Patients With Moderately to Severely Active Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and pharmacokinetics of IPG11406, an investigational oral drug, in adult patients with moderately to severely active ulcerative colitis (UC).
UC is a chronic inflammatory bowel disease that causes long-term inflammation and ulcers in the colon, leading to symptoms like frequent diarrhea, rectal bleeding, abdominal pain, and urgent bowel movements. IPG11406 works by targeting the GPR183 receptor, which helps reduce immune cell migration to the inflamed colon, potentially easing UC symptoms and promoting mucosal healing.
In this study, 144 eligible adult patients will be randomly assigned (1:1:1:1) to receive one of three doses of IPG11406 (10 mg, 20 mg, or 40 mg, taken twice daily by mouth) or a matching placebo for 12 weeks. Neither the patients nor their study doctors will know who is receiving the active drug or placebo to ensure unbiased results.
The main goal of the study is to see how well IPG11406 works to achieve clinical remission (reduced or no UC symptoms) at 12 weeks, measured by the modified Mayo Score. Additional goals include evaluating other efficacy measures (such as clinical response, endoscopic remission, and histological improvement), long-term safety, how the drug is absorbed and processed in the body (pharmacokinetics), and changes in inflammatory biomarkers like fecal calprotectin and hsCRP.
All participants will undergo regular study visits for safety assessments, including physical exams, laboratory tests, colonoscopies, and monitoring for any side effects throughout the 12-week treatment period and a 2-week follow-up. This study will help determine the optimal dose of IPG11406 for future larger clinical trials in UC patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Males and females aged ≥18 and ≤70 years at randomization 2.Diagnosis of moderately to severely active UC with mMS 5-9, mMES 2-3, SF ≥1, RB ≥1 3.Documented UC diagnosis for ≥3 months prior to screening 4.Inadequate response, loss of response, or intolerance to conventional or advanced therapies 5.Stable background UC therapy for specified intervals before baseline 6.Willingness to use effective contraception throughout the study and for 1 month after last dose 7.Ability to comply with study visits and procedures 8.Signed informed consent
排除标准
- •Diagnosis of indeterminate colitis or Crohn's disease
- •History of bowel surgery for UC or likely requiring surgery during study
- •Ulcerative proctitis only (distal ≤15 cm)
- •History of colonic dysplasia or adenomatous polyps not completely removed
- •Active intestinal infection (including C. difficile) within 30 days
- •HBV, HCV, HIV, or untreated latent/active TB
- •Significant cardiovascular disease or uncontrolled hypertension
- •Clinically significant abnormal ECG or QTcF prolongation
- •Treatment with prohibited medications within specified windows
- •Abnormal laboratory values at screening
- •History of malignancy (except non-melanoma skin cancer or in situ cervical cancer)
- •Pregnancy, breastfeeding, or plan to become pregnant
- •Alcohol or drug abuse within 6 months
- •Prior participation in an IPG11406 study
- •Other conditions deemed inappropriate by the investigator
研究组 & 干预措施
IPG11406 40 mg BID
Participants in this arm receive IPG11406 40 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design.
干预措施: IPG11406 (Drug)
Placebo
Participants in this arm receive matching placebo oral tablets twice daily (BID) for 12 weeks, identical in appearance to IPG11406, to maintain the double-blind study design.
干预措施: Placebo (Drug)
IPG11406 10 mg BID
Participants in this arm receive IPG11406 10 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design.
干预措施: IPG11406 (Drug)
IPG11406 20 mg BID
Participants in this arm receive IPG11406 20 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design.
干预措施: IPG11406 (Drug)
结局指标
主要结局
Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
时间窗: week 12
Clinical remission: mMS ≤2 with all subscores ≤1; stool frequency subscore 0 or 1 and ≥1 point decrease from baseline; rectal bleeding subscore 0; modified Mayo endoscopic subscore 0 or 1 (without friability for score 1)
次要结局
- Proportion of participants achieving clinical response based on mMS at Week 12(Week 12)
- Proportion of participants achieving clinical response based on full Mayo Score at Week 12(Week 12)
- Proportion of participants achieving clinical remission based on full Mayo Score at Week 12(Week 12)
- Proportion of participants achieving combined PRO2 remission and endoscopic remission at Week 12(Week 12)
- Proportion of participants achieving endoscopic remission at Week 12(Week 12)