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

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07265570

Title field or adapter rule

{'original_value': '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', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:35.995938+00:00

Published At

2026-10-29T00:00:00+00:00

Record Updated At

2026-10-29

Source Retrieved At

2026-10-31T22:18:58.295941+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Ulcerative Colitis"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-29", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07265570"

protocolSection.identificationModule.officialTitle

"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"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Ulcerative Colitis (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Patients assigned to Cohort 1 will receive ISM5411 tablets up to 12 weeks.'], 'description': 'Dosage Form: Tablet; Frequency of administration: Orally QD.', 'name': 'ISM5411 tablets', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Patients assigned to Cohort 2 will receive ISM5411 tablets up to 12 weeks.'], 'description': 'Dosage Form: Tablet; Frequency of administration: Orally QD.', 'name': 'ISM5411 tablets', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Patients assigned to Cohort 3 will receive ISM5411 tablets up to 12 weeks.'], 'description': 'Dosage Form: Tablet ; Frequency of administration: Orally QD.', 'name': 'ISM5411 tablets', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Patients assigned to Cohort 4 will receive placebo up to 12 weeks.'], 'description': 'Dosage Form: Tablet; Frequency of administration: Orally QD.', 'name': 'Placebo', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• ISM5411 tablets (protocolSection.armsInterventionsModule.interventions[].name)
• ISM5411 tablets (protocolSection.armsInterventionsModule.interventions[].name)
• ISM5411 tablets (protocolSection.armsInterventionsModule.interventions[].name)
• Placebo (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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