A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT07071519

Title field or adapter rule

{'original_value': 'A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:36.189200+00:00

Published At

2026-10-27T00:00:00+00:00

Record Updated At

2026-10-27

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": "2026-10-27", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT07071519"

protocolSection.identificationModule.officialTitle

"A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to \u003c 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Ulcerative Colitis (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Expansion Cohort 3: SS1', 'PK Cohort 1: SS1', 'PK Cohort 2: SS1'], 'description': 'Risankizumab intravenous (IV) infusion', 'name': 'Risankizumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Expansion Cohort 3: SS2 Dose A', 'Expansion Cohort 3: SS2 Dose B', 'Expansion Cohort 3: SS3 Dose A', 'Expansion Cohort 3: SS3 Dose B', 'PK Cohort 1: SS2 Dose A', 'PK Cohort 1: SS2 Dose B', 'PK Cohort 1: SS3 Dose A', 'PK Cohort 1: SS3 Dose B', 'PK Cohort 2: SS2 Dose A', 'PK Cohort 2: SS2 Dose B', 'PK Cohort 2: SS3 Dose A', 'PK Cohort 2: SS3 Dose B'], 'description': 'Risankizumab subcutaneous (SC) injection', 'name': 'Risankizumab', '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

• Risankizumab (protocolSection.armsInterventionsModule.interventions[].name)
• Risankizumab (protocolSection.armsInterventionsModule.interventions[].name)

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

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