NCT07229950招募中2 期
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年10月17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
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Proportion of subjects experiencing at least one Adverse Event
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
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 and female subject age ≥ 18，≤
- •the body mass index (BMI= weight (kg)/height (2 m ²)) of the subjects is ≥ 18 kg/m ².
- •Subject has active Ulcerative Colitis with a 9-point modified Mayo score of 4-9 at baseline, with an endoscopic subscore of ≥ 2 (confirmed by central read), and rectal bleeding subscore of ≥
- •Subject has at least a 90-days history of Ulcerative Colitis diagnosis at baseline.
- •Subject is deemed by the physician as having inadequate response, loss of response or intolerance to at least one conventional treatment (oral 5-ASA, immunosuppressants or corticosteroids), or anti-TNF therapy (e.g., infliximab, adalimumab) or other biological, or JAK inhibitors treatment.
- •Subject is capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspects of the study.
- •All women of childbearing potential and their male partners must commit to using a highly effective contraception to 3 months after last dose of study medication.
排除标准
- •Subject has a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's Disease.
- •Subject with Ulcerative Colitis, which is confined to a proctitis (distal 15 cm or less).
- •Treatment naïve subject diagnosed with Ulcerative Colitis.
- •Subject is displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon.
- •Subject had previous surgery as a treatment for Ulcerative Colitis or likely to require surgery during the study period.
- •Screening endoscopic examination revealed that the subjects had a history of gastrointestinal dysplasia (atypical hyperplasia)/cancer or dysplasia (atypical hyperplasia)/cancer. Except for completely resected low-grade dysplasia.
- •Subject has evidence of pathogenic bowel infection. Subjects had Clostridium difficile or other intestinal infection within 30 days of screening endoscopy or test positive at screening for C. difficile toxin or other intestinal pathogens.
- •Subject currently has or had:
- •8.1 A clinically significant infection within 1 month of baseline. 8.2 A history of more than one episode of herpes zoster, or disseminated zoster (single episode).
- •8.3 Any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
- •8.4Any infection requiring antimicrobial therapy within 2 weeks of screening.
- •Subject is receiving any of the following therapies:
- •9.1 Cyclosporine, mycophenolate, tacrolimus、JAK inhibitors within 4 weeks prior to baseline.
- •9.2 Interferon therapy within 8 weeks prior to baseline. 9.3 Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline.
研究组 & 干预措施
Treatment group C: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Treatment group B: HRS-7085 High dose
Experimental
干预措施: HRS-7085 (Drug)
Treatment group A: HRS-7085 Low dose
Experimental
干预措施: HRS-7085 (Drug)
结局指标
主要结局
Proportion of subjects experiencing at least one Adverse Event
时间窗: at Week 14
次要结局
- Proportion of subjects achieving clinical response(at Week 8)
- Proportion of subjects achieving symptomatic remission,(at Week 8)
- Proportion of subjects achieving clinical remission(at Week 8)
- Change from baseline in partial Mayo score,(at week8、week12)
- Change from baseline in EQ-5D-5L (5-Level EuroQol 5-Dimension) index score,(at Week 8)
- Peak Plasma Concentrations (Cmax)(at Week 4)
- Area Under the Curve (AUC) of Plasma Concentrations(at Week 4)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Phase 2 Clinical Study of CU-20401Efficacy and SafetyNCT06194188Cutia Therapeutics（Wuxi）Co.,Ltd108
尚未招募
2 期
A Study to Find the Best Dose of HS-10384 to Treat Vasomotor Symptoms in Postmenopausal WomenVasomotor SymptomsNCT06393673Hansoh BioMedical R&D Company195
已完成
2 期
A Study of Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)Hypertension, PulmonaryNCT04945460Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA165
已完成
1 期
Efficacy and Safety of Molnupiravir in Healthy Participants Inoculated With Experimental Influenza Virus (MK-4482-019)Influenza InfectionNCT05818124Merck Sharp & Dohme LLC161
已完成
2 期
Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)Pulmonary Arterial HypertensionNCT01553721Dong-A ST Co., Ltd.63