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Recruiting Phase 3 Interventional

A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease

ClinicalTrials.gov ID: NCT05995353

Public ClinicalTrials.gov record NCT05995353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 10:24 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT05995353
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AbbVie
Industry
Enrollment
110 participants

Conditions and interventions

Interventions

  • Risankizumab Drug

Drug

Eligibility (public fields only)

Age range
2 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 10, 2023
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029
Last update posted
May 12, 2026

2023 – 2029

United States locations

U.S. sites
11
U.S. states
11
U.S. cities
11
Facility City State ZIP Site status
Phoenix Children's Hospital /ID# 255766 Phoenix Arizona 85016-7710 Recruiting
Arkansas Children's Hospital /ID# 255762 Little Rock Arkansas 72202 Recruiting
UCSF Benioff Children's Hospital - Oakland /ID# 258327 Oakland California 94609 Recruiting
Children's Hospital Colorado - Aurora /ID# 255764 Aurora Colorado 80045 Recruiting
Arnold Palmer Hospital for Children Center Digestive Health & Nutrition - Orland /ID# 255437 Orlando Florida 32806-1141 Recruiting
Indiana University Health Riley Hospital for Children /ID# 256454 Indianapolis Indiana 46202 Recruiting
Massachusetts General Hospital /ID# 255767 Boston Massachusetts 02114 Recruiting
MNGI Digestive Health, P. A. /ID# 255366 Minneapolis Minnesota 55413-2195 Recruiting
Goryeb Childrens Hospital /ID# 256452 Morristown New Jersey 07960 Recruiting
Icahn School of Medicine at Mount Sinai /ID# 254880 New York New York 10029 Recruiting
Cleveland Clinic - Cleveland /ID# 256453 Cleveland Ohio 44195 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05995353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 12, 2026 · Synced May 20, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05995353 live on ClinicalTrials.gov.

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