NCT07755241尚未招募2 期
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of AC-101 Tablets in Patients With Moderately to Severely Active Ulcerative Colitis
Accro Bioscience (Suzhou) Limited0 个研究点目标入组 153 人开始时间: 2026年8月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 153
- 主要终点
- Clinical Remission
研究概览
简要总结
This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will evaluate the efficacy, safety, and pharmacokinetics of AC-101 compared with placebo in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies. The study consists of a screening period (up to 4 weeks), a 12-week induction period, a 40-week extension period, and a 4-week safety follow-up period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged ≥ 18 and ≤ 75 years；
- •Must sign the Informed Consent Form and be willing to participate in the study.
- •Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence.
- •Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥
- •Documented failure to prior advanced therapies or prior conventional therapies
- •Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment:
- •Female participants of non-childbearing potential;
- •Female participants of childbearing potential who are not pregnant must agree to use highly effective contraception during the treatment period and for at least 1 month after the last dose of study treatment;
- •Male participants with a pregnant or non-pregnant female partner of childbearing potential must agree to use contraception during the treatment period and for at least 1 month after the last dose of study treatment.
排除标准
- •Severe extensive colitis.
- •Hospitalization for exacerbation of UC within 12 weeks prior to screening.
- •History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy.
- •Adenomatous colonic polyps that have not been removed prior to study enrollment.
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease.
- •Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening.
- •Presence of an ostomy or fistula.
- •Risk of tuberculosis .
- •History of current or prior serious opportunistic infection.
- •Presence of active or chronic recurrent infection.
- •Patients with any of the following hepatitis B screening results:
- •Acute or chronic hepatitis B infection; or Positive hepatitis B virus (HBV) test at screening (HBsAg positive); or HBsAg negative, hepatitis B core antibody (HBcAb) positive, with detectable HBV-DNA.
- •Current hepatitis C infection, or positive hepatitis C virus (HCV) test at screening.
- •Human immunodeficiency virus (HIV) infection/acquired immunodeficiency syndrome , or positive HIV antibody test at screening.
- •Syphilis, or positive syphilis-specific antibody test at screening.
- •Treatment with advanced therapies for UC within 8 weeks or 5 half-lives prior to randomization.
- •Treatment with intravenous corticosteroids within 2 weeks prior to randomization.
- •Treatment with leukocyte apheresis within 12 weeks prior to randomization.
- •Treatment with intravenous immunoglobulins or plasmapheresis within 12 weeks prior to randomization.
- •Treatment with lymphocyte-depleting therapy.
- •History of fecal microbiota transplantation.
- •Vaccination with live attenuated vaccines within 4 weeks prior to randomization, or a plan to receive such vaccines during the study period.
- •Requirement for parenteral nutrition.
- •History of myocardial infarction, acute stroke, transient ischemic attack, thromboembolic events, clinically significant arrhythmia, unstable angina, coronary artery bypass grafting, or severe pulmonary heart disease/pulmonary hypertension within 3 months prior to randomization, which, in the investigator's judgment, may affect the evaluation of study results.
- •Presence of any other unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological/psychiatric, or other medical condition that, in the investigator's judgment, may interfere with the study results.
- •Known history of immunodeficiency; other acquired or congenital immunodeficiency disorders; or history of organ transplantation.
- •History of malignancy within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin.
- •Female patients who are pregnant, lactating, or have a positive serum pregnancy test at screening.
- •Any other condition that, in the investigator's opinion, may affect the patient's safety or compliance, or preclude the patient from completing the study.
研究组 & 干预措施
AC-101 cohort 2
Experimental
Patients will receive AC-101 Dose 2 as tablets orally twice daily
干预措施: AC-101 (Drug)
AC-101 cohort 1
Experimental
Patients will receive AC-101 Dose 1 as tablets orally twice daily
干预措施: AC-101 (Drug)
Placebo
Placebo Comparator
Patients will receive oral placebo tablets twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Remission
时间窗: Week 12
Clinical remission at Week 12, defined as stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, AND centrally read endoscopy subscore of 0 or 1
次要结局
- Clinical response(Week 12)
- Symptomatic remission(Week 12)
- Adverse Events(Up to 56 Weeks)
研究者
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