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New pill aims to tame ulcerative colitis Flare-Ups

NCT ID NCT07265570

Disease control Sponsor: InSilico Medicine Hong Kong Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 3 times

Summary

This study tests an experimental pill called ISM5411 (Garutadustat) in 80 adults with active ulcerative colitis. Half receive the drug, half a placebo, and neither patients nor doctors know who gets what. The goal is to check if the drug is safe and helps control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ISM5411 (Garutadustat) tablets
What this could lead to
If successful, this could point toward a new oral treatment option for people with active ulcerative colitis.
What could go wrong
This is an early Phase 2 trial with only 80 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject who fully understand the content, process and possible adverse events of the study and capable of giving written informed consent form (ICF). 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 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: 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 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 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 ECG at screening, including QTcF \> 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 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. 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.

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

  • Binzhou Medical University Hospital

    RECRUITING

    Binzhou, Shandong, China

  • First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, China

  • Guangzhou First People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Huizhou First Hospital

    RECRUITING

    Huizhou, Guangdong, China

  • Lishui Central Hospital

    RECRUITING

    Lishui, Zhejiang, China

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Meihekou Central Hospital

    RECRUITING

    Tonghua, Jilin, China

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, China

  • Tai 'an City Central Hospital

    RECRUITING

    Taian, Shandong, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Gannan Medical University

    RECRUITING

    Ganzhou, Jiangxi, China

  • The First Affiliated Hospital of Henan University of Science & Technology

    RECRUITING

    Luoyang, Henan, China

  • The First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, China

  • The First Affiliated Hospital of University of South China

    RECRUITING

    Hengyang, Hunan, China

  • The First Affiliated Hospital of Xinxiang Medical University

    RECRUITING

    Xinxiang, Henan, China

  • The First Affiliated Hospital,Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    RECRUITING

    Nanning, Guangxi, China

  • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The Second Hospital of HeBei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The Third Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, China

  • Tianjin People's Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • West China School of Medicine and West China Hospital Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xi'an Central Hospital

    RECRUITING

    Xian, Shanxi, China

  • ZhongDa Hospital Southeast University

    RECRUITING

    Nanjing, Jiangsu, China

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