Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
NCT ID: NCT07265570
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-12-10
2027-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks.
ISM5411 tablets
Dosage Form: Tablet; Frequency of administration: Orally QD.
Patients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks.
ISM5411 tablets
Dosage Form: Tablet; Frequency of administration: Orally QD.
Patients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks.
ISM5411 tablets
Dosage Form: Tablet ; Frequency of administration: Orally QD.
Patients assigned to Cohort 4 will receive placebo up to 12 weeks.
Placebo
Dosage Form: Tablet; Frequency of administration: Orally QD.
Interventions
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ISM5411 tablets
Dosage Form: Tablet; Frequency of administration: Orally QD.
ISM5411 tablets
Dosage Form: Tablet; Frequency of administration: Orally QD.
ISM5411 tablets
Dosage Form: Tablet ; Frequency of administration: Orally QD.
Placebo
Dosage Form: Tablet; Frequency of administration: Orally QD.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Female subjects must be nonpregnancy and nonlactating. Subjects (male or female) are willing to take medically approved effective contraceptive measures from the screening period to 3 months after the last administration and have no sperm or egg donation plan during the study period and within 3 months after the last dose.
3. Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF.
4. Subject has a diagnosis of UC for at least 3 months prior to screening, and meets the criteria defined in the current protocol.
5. If the subjects have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
Exclusion Criteria
2. Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia.
3. Subjects have received surgery for UC or any other type of major intestinal surgery (i.e., surgical procedure requiring general anesthesia) or are likely to require related surgery during the study.
4. Subjects have evidence of a pathogenic intestinal infection, or have a Clostridium Difficile infection or other intestinal infection within 30 days prior to the screening endoscopy or have tested positive for Clostridium Difficile toxins or other intestinal pathogens at the screening period.
5. Subjects have chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, make them an unsuitable candidate for the study.
6. Subjects who are unable to take oral medications and/or have an impact on absorption of medication due to severe malnutrition or disease and surgery, etc., or who are currently receiving or plan to receive total parenteral nutrition (TPN) during the study period.
7. Subjects who have received the relevant treatments defined in the protocol.
8. Subjects with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection.
9. Subjects who have the risks of tuberculosis defined in the protocol.
10. Subjects have any of the infection defined in the protocol.
11. Subjects who are known to be allergic to the investigational product or any components of it or who have allergic constitution (allergy to multiple drugs or foods).
12. Subjects have unstable or uncontrolled and clinically significant allergic (except for untreated, asymptomatic, seasonal allergies), hematological, endocrine/metabolic, coagulation, immunologic, pulmonary, cardiovascular, hepatic (expect hepatic steatohepatitis), digestion system (expect UC), genitourinary, psychiatric, oncologic or neurological disease or other medical disorder that would make them ineligible for the study.
13. Subjects have concomitant illness that in the opinion of the investigator, are likely to require systemic glucocorticosteroid therapy during the study (e.g., moderate to severe asthma).
14. Subjects have received major organ surgery (except needle biopsy, tracheotomy, gastrotomy, etc.) or significant trauma within 28 days prior to randomization or is likely to require related surgery during the study.
15. Subjects have history of any malignancy within 5 years of screening, except for successfully treated nonmelanoma skin cancer (NMSC), skin basal cell carcinoma, or localized carcinoma in situ of the cervix.
16. Any abnormal results defined in the protocol were identified during the screening period.
17. Subjects have a clinically significant abnormal ECG at screening, including QTcF \> 450 msec for males and \> 470 msec for females.
18. Subjects have difficulty in venous blood collection or history of acupuncture syncope reaction or blood phobia.
19. Subjects have contraindications to colonoscopy, including but not limited to gastrointestinal fistulas, early post abdominal surgery, severe coagulopathy, large abdominal aneurysms, or any condition that the investigator determines significantly increases the risk of colonoscopy complications.
20. Subjects have a history of alcohol or drug abuse within 3 months of screening, according to the judgement of the investigator. Alcohol abuse refers to consuming alcohol at least twice per day or more than 14 units of alcohol per week.
21. Subjects are unable to maintain smoking and alcohol abstinence during the study.
22. Subjects have participated in other clinical trials of other drugs or medical devices within 30 days prior to screening period and have already received the investigational product, or are currently participating in another clinical trial of a drug or medical device.
23. Subjects are deemed by the investigator to be inappropriate for the study; or have any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or are unable or unwilling to comply with the study protocol.
18 Years
75 Years
ALL
No
Sponsors
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InSilico Medicine Hong Kong Limited
INDUSTRY
Responsible Party
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Locations
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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
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
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
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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ISM5411-201
Identifier Type: -
Identifier Source: org_study_id
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