RecruitingPhase 2interventionalRules rewrite

Phase 2: testing ISM5411 tablets for Ulcerative Colitis

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the safety, tolerability, pharmacokinetics and clinical how well it works of ISM5411 in adult patients with active ulcerative colitis.

Official registry: https://clinicaltrials.gov/study/NCT07265570 · InSilico Medicine Hong Kong Limited · enrollment listed as 80

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ISM5411 tablets, ISM5411 tablets, or ISM5411 tablets. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the safety, tolerability, pharmacokinetics and clinical how well it works of ISM5411 in adult patients with active ulcerative colitis.

They plan to enroll about 80 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ISM5411 tablets, ISM5411 tablets, ISM5411 tablets, Placebo

Primary outcome (registry wording): The rate of treatment-emergent adverse events (TEAEs) in each group.

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
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 the registry excludes

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 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
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

Public study contact (from the registry)

Yang Deng

+86 021-50831718

Insilico-Clinicaltrial@insilico.ai

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

28 listed

Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (recruiting)
The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (recruiting)
Guangzhou First People's Hospital — Guangzhou, Guangdong, China (recruiting)
The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (recruiting)
Huizhou First Hospital — Huizhou, Guangdong, China (recruiting)
The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (recruiting)
The Second Hospital of HeBei Medical University — Shijiazhuang, Hebei, China (recruiting)
The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (recruiting)
The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (recruiting)
Renmin Hospital of Wuhan University — Wuhan, Hubei, China (recruiting)
The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (recruiting)
The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (recruiting)

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseLeuven, Vlaams-Brabant

Not a traditional drug phase: Sample collection for IBS

Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

NCT02421705 · Official ClinicalTrials.gov record · KU Leuven

RecruitingNot a traditional drug phaseHouston, Texas

Not a traditional drug phase: testing Ustekinumab for Crohn Disease

This study wants to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).

NCT04372108 · Official ClinicalTrials.gov record · Janssen Scientific Affairs, LLC

RecruitingNot a traditional drug phaseToronto, Ontario

The Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Dise…

Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies.

NCT06006039 · Official ClinicalTrials.gov record · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

FAQ about this NCT record

Is NCT07265570 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07265570?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07265570?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary