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New treatment option for Ulcerative Colitis
Official title Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
ClinicalTrials.gov ID: NCT07265570
What this study is testing
What is ISM5411 tablets?
ISM5411 tablets is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
Also referred to as Garutadustat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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 people must be nonpregnancy and nonlactating. people (male or female) are willing to take medically approved effective contraceptive measures...
- 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...
- If the people have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
You likely can't join if
- people have suspected or diagnosed Crohn's disease (CD), undefined colitis, ischemic colitis, fulminant colitis, toxic megacolon, radiation colitis...
- people with previously diagnosed but uneradicated or current gastrointestinal dysplasia.
- people have received surgery for UC or any other type of major intestinal surgery (i.e., surgical procedure requiring general anesthesia) or are...
- people have evidence of a pathogenic intestinal infection, or have a Clostridium Difficile infection or other intestinal infection within 30 days...
- people have chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, make them an unsuitable...
- people who are unable to take oral medications and/or have an impact on absorption of medication due to severe malnutrition or disease and surgery...
See the full eligibility criteria
Who can 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 people must be nonpregnancy and nonlactating. people (male or female) are willing to take medically approved effective contraceptive measures from the screening period to 3 months after the last administration...
- 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 people have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
- If the people have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
What rules you out
- people 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...
- people with previously diagnosed but uneradicated or current gastrointestinal dysplasia.
- people 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.
- people 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...
- people 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.
- people 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...
- people who have received the relevant treatments defined in the protocol.
- people with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection.
- people who have the risks of tuberculosis defined in the protocol.
- people have any of the infection defined in the protocol.
- people 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).
- people have unstable or uncontrolled and clinically significant allergic (except for untreated, asymptomatic, seasonal allergies), hematological, endocrine/metabolic, coagulation, immunologic, pulmonary, cardiovascular...
- people 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).
- people 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.
- people 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.
- people with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) despite medication at screening.
- people have a clinically significant abnormal ECG at screening, including QTcF \> 450 msec for males and \> 470 msec for females.
- people have difficulty in venous blood collection or history of acupuncture syncope reaction or blood phobia.
- people 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...
- people 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...
- people 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...
- people 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, side effects, or PK of the investigational drug; or are...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Huizhou, Guangdong, China
- Nanning, Guangxi, China
- Shijiazhuang, Hebei, China
- Luoyang, Henan, China
- Xinxiang, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hengyang, Hunan, China
- Nanjing, Jiangsu, China
- Ganzhou, Jiangxi, China
- Tonghua, Jilin, China
- Shenyang, Liaoning, China
- Binzhou, Shandong, China
- Taian, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Xian, Shanxi, China
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Huizhou, Guangdong, China; Nanning, Guangxi, China; Shijiazhuang, Hebei, China and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.