Ulcerative ColitisPhase 2NCT07265570
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
A Phase 2 study testing ISM5411 tablets in people with Ulcerative Colitis, run by InSilico Medicine Hong Kong Limited at 28 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- ISM5411 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 28 sitesChina
- Study dates
- 10 Dec 2025to 30 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Any abnormal results defined in the protocol were identified during the screening period.
- Subjects with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) despite medication at screening.
- Subjects have a clinically significant abnormal ECG at screening, including QTcF > 450 msec for males and > 470 msec for females.
- Subjects have difficulty in venous blood collection or history of acupuncture syncope reaction or blood phobia.
- 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.
- 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.
- 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.
- 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.
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
China28 sites, 28 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
- Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
- Recruiting
West China School of Medicine and West China Hospital Sichuan University
Chengdu, Sichuan
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
- Recruiting
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan
- Recruiting
Huizhou First Hospital
Huizhou, Guangdong
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang
- Recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
- Recruiting
ZhongDa Hospital Southeast University
Nanjing, Jiangsu
- Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
- Recruiting
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
- Recruiting
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
- Recruiting
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei
- Recruiting
Tai 'an City Central Hospital
Taian, Shandong
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
- Recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality
- Recruiting
Meihekou Central Hospital
Tonghua, Jilin
- Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
- Recruiting
Xi'an Central Hospital
Xian, Shanxi
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
About this study
Official title: 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
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.
Read the detailed description
ISM5411 is a gut-restricted small-molecule prolyl hydroxylase (PHD) inhibitor. It can promote the expression of intestinal mucosal protective genes and maintain the integrity and functions of intestinal barrier together with anti-inflammation. It is expected to become a safe and effective therapy to overcome the shortcomings of traditional simple anti-inflammatory drugs.
- Conditions
- Ulcerative Colitis
- Being tested
- ISM5411 tablets, Placebo
- Keywords
- Prolyl hydroxylase (PHD) inhibitor, Ulcerative colitis（UC）, Inflammatory bowel disease (IBD)
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISM5411 tabletsDrug
Also called Garutadustat
Dosage Form: Tablet; Frequency of administration: Orally QD.
ISM5411 tabletsDrug
Also called Garutadustat
Dosage Form: Tablet; Frequency of administration: Orally QD.
ISM5411 tabletsDrug
Also called Garutadustat
Dosage Form: Tablet ; Frequency of administration: Orally QD.
PlaceboDrug
Dosage Form: Tablet; Frequency of administration: Orally QD.
| Study group | Role | What they receive |
|---|---|---|
| Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks. | Experimental | Not described Receives: Drug: ISM5411 tablets |
| Patients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks. | Experimental | Not described Receives: Drug: ISM5411 tablets |
| Patients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks. | Experimental | Not described Receives: Drug: ISM5411 tablets |
| Patients assigned to Cohort 4 will receive placebo up to 12 weeks. | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of treatment-emergent adverse events (TEAEs) in each group.
To evaluate the safety and tolerability of ISM5411.
Measured: 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.
Measured: 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.
Measured: Up to 16 weeks.
Secondary outcomes (10)
Peak plasma concentration (Cmax)
To evaluate pharmacokinetics (PK) of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Peak plasma time (Tmax)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-inf).
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t).
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Terminal rate constant (λz)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Elimination half-life (t1/2)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Apparent volume of distribution (Vz/F)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Apparent clearance (CL/F)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Mean residence time (MRT)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Colonic tissue concentration (Ccolon)
To evaluate PK of ISM5411 in moderately to severely active UC patients.
Measured: Week1 to Week12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start10 Dec 2025
- Primary completion15 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InSilico Medicine Hong Kong Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265570
- Sponsor's protocol ID
- ISM5411-201
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07265570
- Acronym / sponsor ID
- ISM5411-201
- Conditions
- Ulcerative Colitis
- Keywords
- Prolyl hydroxylase (PHD) inhibitor, Ulcerative colitis（UC）, Inflammatory bowel disease (IBD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- InSilico Medicine Hong Kong LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ISM5411 is a gut-restricted small-molecule prolyl hydroxylase (PHD) inhibitor. It can promote the expression of intestinal mucosal protective genes and maintain the integrity and functions of intestinal barrier together with anti-inflammation. It is expected to become a safe and effective therapy to overcome the shortcomings of traditional simple anti-inflammatory drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks. | Experimental | Drug: ISM5411 tablets |
| Patients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks. | Experimental | Drug: ISM5411 tablets |
| Patients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks. | Experimental | Drug: ISM5411 tablets |
| Patients assigned to Cohort 4 will receive placebo up to 12 weeks. | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISM5411 tabletsAlso: GarutadustatDosage Form: Tablet; Frequency of administration: Orally QD. | Drug | Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks. |
| ISM5411 tabletsAlso: GarutadustatDosage Form: Tablet; Frequency of administration: Orally QD. | Drug | Patients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks. |
| ISM5411 tabletsAlso: GarutadustatDosage Form: Tablet ; Frequency of administration: Orally QD. | Drug | Patients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks. |
| PlaceboDosage Form: Tablet; Frequency of administration: Orally QD. | Drug | Patients assigned to Cohort 4 will receive placebo up to 12 weeks. |
Primary outcome
The rate of treatment-emergent adverse events (TEAEs) in each group.
Time frame: Week1 to Week12.
To evaluate the safety and tolerability of ISM5411.
The rate of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of treatment in each group.
Time frame: Up to 16 weeks.
To evaluate the safety and tolerability of ISM5411.
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.
Time frame: Up to 16 weeks.
To evaluate the safety and tolerability of ISM5411.
10 secondary outcomes
Peak plasma concentration (Cmax)
Time frame: Week1 to Week12.
Peak plasma time (Tmax)
Time frame: Week1 to Week12.
Area under the plasma concentration-time curve extrapolated from time zero to infinity (AUC0-inf).
Time frame: Week1 to Week12.
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t).
Time frame: Week1 to Week12.
Terminal rate constant (λz)
Time frame: Week1 to Week12.
Elimination half-life (t1/2)
Time frame: Week1 to Week12.
Apparent volume of distribution (Vz/F)
Time frame: Week1 to Week12.
Apparent clearance (CL/F)
Time frame: Week1 to Week12.
Mean residence time (MRT)
Time frame: Week1 to Week12.
Colonic tissue concentration (Ccolon)
Time frame: Week1 to Week12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISM5411 tablets in people with Ulcerative Colitis, run by InSilico Medicine Hong Kong Limited at 28 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Deng (+86 021-50831718, Insilico-Clinicaltrial@insilico.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of treatment-emergent adverse events (TEAEs) in each group. (time frame: Week1 to Week12.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.