Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) (NCT07265570) | Clinical Trial Compass
RecruitingPhase 2
Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)
China80 participantsStarted 2025-12-10
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Subject who fully understand the content, process and possible adverse events of the study and capable of giving written informed consent form (ICF).
ā. 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.
ā. Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF.
ā. 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.
ā. If the subjects have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
ā. If the subjects have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled.
Exclusion criteria
ā. 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.
ā. Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia.
ā. 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.
What they're measuring
1
The rate of treatment-emergent adverse events (TEAEs) in each group.
Timeframe: Week1 to Week12.
2
The rate of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of treatment in each group.
Timeframe: 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.
ā. 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.
ā. 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.
ā. 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.
ā. Subjects who have received the relevant treatments defined in the protocol.
ā. Subjects with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection.