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RecruitingNCT07265570Updated Oct 29, 2026

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

A Phase 2 interventional study of ISM5411 tablets and ISM5411 tablets in Ulcerative Colitis, sponsored by InSilico Medicine Hong Kong Limited. Recruiting at 28 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by InSilico Medicine Hong Kong Limited · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ulcerative Colitis

Keywords

  • Prolyl hydroxylase (PHD) inhibitor
  • Ulcerative colitis（UC）
  • Inflammatory bowel disease (IBD)
03

In context

Colitis, Ulcerative

1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.

This study's planned enrollment of 80 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

InSilico Medicine Hong Kong Limited is the lead sponsor of 11 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject who fully understand the content, process and possible adverse events of the study and capable of giving written form (ICF).
  2. Female subjects must be nonpregnancy and nonlactating. Subjects (male or female) are willing to take medically approved effective 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 ulcerative colitis for at least 3 months prior to colonoscopy during the screening period, 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.
  6. If the subjects have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  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 product or any components of it or who have allergic constitution (allergy to multiple drugs or foods).
  12. Subjects have unstable or uncontrolled and 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 , 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 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 with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) despite medication at screening.
  18. Subjects have a clinically significant abnormal at screening, including > 450 msec for males and > 470 msec for females.
  19. Subjects have difficulty in venous blood collection or history of acupuncture syncope reaction or blood phobia.
  20. Subjects have 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.
  21. 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.
  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.
Terms in these criteria, in plain language(9)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks.

    Drug: ISM5411 tablets

  • Experimental
    Patients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks.

    Drug: ISM5411 tablets

  • Experimental
    Patients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks.

    Drug: ISM5411 tablets

  • Placebo comparator
    Patients assigned to Cohort 4 will receive placebo up to 12 weeks.

    Drug: Placebo

Interventions

  • DrugISM5411 tablets

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

    Also known as: Garutadustat

  • DrugISM5411 tablets

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

    Also known as: Garutadustat

  • DrugISM5411 tablets

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

    Also known as: Garutadustat

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. The rate of treatment-emergent adverse events (TEAEs) in each group.

    To evaluate the safety and tolerability of ISM5411.

    Time frame: Week1 to Week12.

  2. 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.

    Time frame: Up to 16 weeks.

  3. 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.

    Time frame: Up to 16 weeks.

Secondary outcomes

  1. Peak plasma concentration (Cmax)

    To evaluate pharmacokinetics (PK) of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

  2. Peak plasma time (Tmax)

    To evaluate PK of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

  3. 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.

    Time frame: Week1 to Week12.

  4. 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.

    Time frame: Week1 to Week12.

  5. Terminal rate constant (λz)

    To evaluate PK of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

  6. Elimination half-life (t1/2)

    To evaluate PK of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

  7. Apparent volume of distribution (Vz/F)

    To evaluate PK of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

  8. Apparent clearance (CL/F)

    To evaluate PK of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

  9. Mean residence time (MRT)

    To evaluate PK of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

  10. Colonic tissue concentration (Ccolon)

    To evaluate PK of ISM5411 in moderately to severely active UC patients.

    Time frame: Week1 to Week12.

Other outcomes

  1. The total number and proportion of subjects who achieve clinical remission.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose

  2. The total number and proportion of subjects who achieve clinical response.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  3. The total number and proportion of subjects who achieve symptomatic remission.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose

  4. The total number and proportion of subjects who achieve endoscopic response.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  5. The total number and proportion of subjects who achieve endoscopic improvement.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  6. The total number and proportion of subjects who achieve endoscopic remission.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  7. Change from baseline (CFB) in modified Mayo Score and Mayo subscore (including rectal bleeding score [RBS], stool frequency score [SFS] and Mayo endoscopic score [MES]) .

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  8. The total number and proportion of subjects who achieve histological response.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  9. The total number and proportion of subjects who achieve histological remission.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose

  10. CFB in Robarts Histopathology Index (RHI) Score and Geboes Score.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  11. CFB in the concentration of fecal calprotectin (FC)

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients

    Time frame: At Week 2, Week 6, and Week 12 postdose.

  12. CFB in the concentration of high-sensitivity C-reactive protein (hs-CRP) .

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 2, Week 6, and Week 12 postdose.

  13. CFB in the expression level of erythropoietin (EPO) and vascular endothelial growth factor-A (VEGF-A) in serum (or plasma).

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: After Day 1 dosing (4 h, 8 h and 12 h) and at Week 2, Week 6, and Week 12 postdose.

  14. CFB in the expression level of hypoxia-inducible factor-1α (HIF-1α) in colonic tissue.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  15. CFB in the expression levels of pharmacodynamic-related genes in colonic tissue.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 12 postdose.

  16. CFB in the concentration of fecal Neutrophil gelatinase-associated lipocalin-2 (NGAL/LCN-2).

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 2, Week 6, and Week 12 postdose.

  17. CFB in the serum or plasma levels of proteomes related to inflammation using proteomics.

    To evaluate the clinical efficacy of ISM5411 on disease activity by analyzing the symptoms, endoscopy, histopathology, and biomarkers in active UC patients.

    Time frame: At Week 6 and Week 12 postdose

07

Study locations

28 of 28 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Aug 2027, 20 months after the start.

Of 109 industry-sponsored phase 2 interventional studies under Colitis, Ulcerative, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 35. This study's planned 20 months is below that.

Counting every sponsor, half of 153 studies reached it within 28 months; a quarter within 22 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2025
First posted
Dec 5, 2025
StartActual
Dec 10, 2025
Primary completionEst.
Aug 15, 2027
CompletionEst.
Aug 30, 2027
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Secondary outcomes
1 edited, 2 added
What changed in the outcomes
  • Editedother outcomeCFB in Robarts Histopathology Index (RHI) Score and Geboes Score.Time frame: At Week 12 postdose.
  • Addedother outcomeThe total number and proportion of subjects who achieve endoscopic improvement.Time frame: At Week 12 postdose.
  • Addedother outcomeCFB in the expression levels of pharmacodynamic-related genes in colonic tissue.Time frame: At Week 12 postdose.
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Secondary outcomes 1 edited, 2 added
    What changed in the outcomes
    • Editedother outcomeCFB in Robarts Histopathology Index (RHI) Score and Geboes Score.Time frame: At Week 12 postdose.
    • Addedother outcomeThe total number and proportion of subjects who achieve endoscopic improvement.Time frame: At Week 12 postdose.
    • Addedother outcomeCFB in the expression levels of pharmacodynamic-related genes in colonic tissue.Time frame: At Week 12 postdose.

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07265570
Lead sponsor
InSilico Medicine Hong Kong Limited
Responsible party
Sponsor
First posted
Dec 5, 2025
Start date
Dec 10, 2025
Primary completion
Aug 15, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Yang Deng
Contact
Insilico-Clinicaltrial@insilico.ai
+86 021-50831718

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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