RecruitingPhase 2NCT07265570

Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)

A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of ISM5411 in Adult Patients With Active Ulcerative Colitis

Sponsor

InSilico Medicine Hong Kong Limited

Enrollment

80 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral (taken by mouth) drug called ISM5411 for people with moderate to severe active ulcerative colitis — a chronic bowel condition that causes inflammation and ulcers in the large intestine. The goal is to assess how safe and effective this new drug is. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with ulcerative colitis for at least 3 months - Your ulcerative colitis is currently moderately to severely active - You are not pregnant or breastfeeding and are willing to use reliable contraception during the study **You may NOT be eligible if...** - You have Crohn's disease, ischemic colitis, or other types of bowel disease - You have had bowel surgery or are likely to need it during the study - You have a current intestinal infection (including C. difficile) - You have had a cancer diagnosis in the past 5 years (some skin cancers may be exceptions) - You have active hepatitis B or C, tuberculosis, or HIV - You have significant heart, liver, lung, or psychiatric conditions - You have a history of alcohol or drug abuse in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGISM5411 tablets

Dosage Form: Tablet; Frequency of administration: Orally QD.

DRUGISM5411 tablets

Dosage Form: Tablet; Frequency of administration: Orally QD.

DRUGISM5411 tablets

Dosage Form: Tablet ; Frequency of administration: Orally QD.

DRUGPlacebo

Dosage Form: Tablet; Frequency of administration: Orally QD.

Locations(28)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, China

Huizhou First Hospital

Huizhou, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

ZhongDa Hospital Southeast University

Nanjing, Jiangsu, China

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

Meihekou Central Hospital

Tonghua, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Tai 'an City Central Hospital

Taian, Shandong, China

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Xi'an Central Hospital

Xian, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China School of Medicine and West China Hospital Sichuan University

Chengdu, Sichuan, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Lishui Central Hospital

Lishui, Zhejiang, China

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07265570

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