Actively Recruiting
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
Led by InSilico Medicine Hong Kong Limited · Updated on 2026-03-31
80
Participants Needed
28
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide written informed consent.
- Female participants must not be pregnant or breastfeeding.
- Willing to use effective contraception from screening until 3 months after last dose and no plans for sperm or egg donation during this period.
- Age between 18 and 75 years at the time of consent.
- Diagnosed with ulcerative colitis for at least 3 months before screening colonoscopy and meet protocol criteria.
- Meet relevant criteria if using or discontinuing concomitant medications defined in the protocol.
You will not qualify if you...
- Suspected or diagnosed Crohn's disease, undefined colitis, ischemic colitis, fulminant colitis, toxic megacolon, radiation colitis, gastrointestinal perforation (other than appendicitis or penetrating injury), diverticular disease with colitis, enterophthisis, abdominal abscess or fistula.
- Previous or current gastrointestinal dysplasia.
- History of surgery for ulcerative colitis or major intestinal surgery requiring general anesthesia, or likely to require such surgery during the study.
- Evidence of pathogenic intestinal infection, including Clostridium Difficile infection within 30 days before screening, or positive tests for intestinal pathogens at screening.
- Chronic recurring or active viral infections making participation unsuitable.
- Unable to take oral medications or with conditions affecting absorption, or receiving/planning total parenteral nutrition during the study.
- Received treatments defined in the protocol that exclude enrollment.
- History of recurrent or disseminated herpes zoster or cytomegalovirus infection.
- Risks of tuberculosis as defined in the protocol.
- Known allergy to investigational product or its components, or multiple drug/food allergies.
- Unstable or uncontrolled significant allergic, hematological, endocrine/metabolic, coagulation, immunologic, pulmonary, cardiovascular, hepatic (except hepatic steatohepatitis), digestive (except ulcerative colitis), genitourinary, psychiatric, oncologic, neurological diseases or other medical disorders making participation unsafe.
- Illness likely to require systemic glucocorticosteroids during the study.
- Major organ surgery or significant trauma within 28 days before randomization or likely to require surgery during the study.
- History of any malignancy within 5 years except successfully treated nonmelanoma skin cancer, basal cell carcinoma, or localized carcinoma in situ of the cervix.
- Abnormal screening results as defined in the protocol.
- Poorly controlled hypertension despite medication at screening.
- Clinically significant abnormal ECG, including QTcF >450 msec for males and >470 msec for females.
- Difficulty with venous blood collection, history of acupuncture syncope, or blood phobia.
- Contraindications to colonoscopy.
- History of alcohol or drug abuse within 3 months before screening.
- Participation in other drug or device clinical trials within 30 days before screening or currently participating in another clinical trial.
- Any condition deemed by the investigator to interfere with safety evaluation or study compliance.
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
2
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
3
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Actively Recruiting
4
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
5
Huizhou First Hospital
Huizhou, Guangdong, China
Actively Recruiting
6
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Actively Recruiting
7
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
8
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Actively Recruiting
9
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Actively Recruiting
10
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
11
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
12
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
Not Yet Recruiting
13
ZhongDa Hospital Southeast University
Nanjing, Jiangsu, China
Actively Recruiting
14
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Actively Recruiting
15
Meihekou Central Hospital
Tonghua, Jilin, China
Actively Recruiting
16
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
17
Binzhou Medical University Hospital
Binzhou, Shandong, China
Actively Recruiting
18
Tai 'an City Central Hospital
Taian, Shandong, China
Actively Recruiting
19
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
20
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
21
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Actively Recruiting
22
Xi'an Central Hospital
Xian, Shanxi, China
Not Yet Recruiting
23
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Actively Recruiting
24
West China School of Medicine and West China Hospital Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
25
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
26
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Actively Recruiting
27
Lishui Central Hospital
Lishui, Zhejiang, China
Not Yet Recruiting
28
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yang Deng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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