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
1 other identifier
interventional
80
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedStudy Start
First participant enrolled
December 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2027
March 31, 2026
November 1, 2025
1.7 years
November 14, 2025
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The rate of treatment-emergent adverse events (TEAEs) in each group.
To evaluate the safety and tolerability of ISM5411.
Week1 to Week12.
The rate of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of treatment in each group.
To evaluate the safety and tolerability of ISM5411.
Up to 16 weeks.
Changes and comparisons of the following data for each group of subjects: vital signs, physical examination, laboratory test(blood routine, blood chemistry, urinalysis, coagulation function, etc.), ECG(Heart rate, RR, PR, QRS,QT, QTcF ), etc.
To evaluate the safety and tolerability of ISM5411.
Up to 16 weeks.
Secondary Outcomes (10)
Peak plasma concentration (Cmax)
Week1 to Week12.
Peak plasma time (Tmax)
Week1 to Week12.
Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-inf).
Week1 to Week12.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t).
Week1 to Week12.
Terminal rate constant (λz)
Week1 to Week12.
- +5 more secondary outcomes
Other Outcomes (15)
The total number and proportion of subjects who achieve clinical remission.
At Week 12 postdose
The total number and proportion of subjects who achieve clinical response.
At Week 12 postdose.
The total number and proportion of subjects who achieve symptomatic remission.
At Week 12 postdose
- +12 more other outcomes
Study Arms (4)
Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks.
EXPERIMENTALPatients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks.
EXPERIMENTALPatients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks.
EXPERIMENTALPatients assigned to Cohort 4 will receive placebo up to 12 weeks.
PLACEBO COMPARATORInterventions
Dosage Form: Tablet; Frequency of administration: Orally QD.
Dosage Form: Tablet; Frequency of administration: Orally QD.
Eligibility Criteria
You may qualify if:
- Subject who fully understand the content, process and possible adverse events of the study and capable of giving written informed consent form (ICF).
- 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.
- Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF.
- Subject has a diagnosis of ulcerative colitis for at least 3 months prior to colonoscopy during the screening period, and meets the criteria defined in the current protocol.
- If the subjects have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
- If the subjects have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
You may not qualify if:
- Subjects have suspected or diagnosed Crohn's disease (CD), undefined colitis, ischemic colitis, fulminant colitis, toxic megacolon, radiation colitis, gastrointestinal perforation (other than appendicitis or penetrating injury), diverticular disease associated with colitis, enterophthisis, abdominal abscess or fistula, etc.
- Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia.
- 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.
- 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.
- 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.
- 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.
- Subjects who have received the relevant treatments defined in the protocol.
- Subjects with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection.
- Subjects who have the risks of tuberculosis defined in the protocol.
- Subjects have any of the infection defined in the protocol.
- 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).
- 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.
- 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).
- 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.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2025
First Posted
December 5, 2025
Study Start
December 10, 2025
Primary Completion (Estimated)
August 15, 2027
Study Completion (Estimated)
August 30, 2027
Last Updated
March 31, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share