A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Public ClinicalTrials.gov record NCT03782376. 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.
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 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
Study identification
- NCT ID
- NCT03782376
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 215 participants
Conditions and interventions
Conditions
Interventions
- Ustekinumab approximately 6 mg/kg (IV) Drug
- Placebo (SC) Drug
- Placebo (IV) Drug
- Ustekinumab 90 mg (SC) Group 1 Drug
- Ustekinumab 90 mg (SC) Group 2 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 20, 2018 (Actual)
- Primary completion
- Aug 19, 2022 (Actual)
- Completion
- Jan 10, 2023 (Actual)
- Last update posted
- Apr 29, 2025
2018 – 2023
United States locations
- U.S. sites
- 28
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Florida Research Network, LLC | Gainesville | Florida | 32605 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| Advent Health | Orlando | Florida | 32803 | — |
| Florida Hospital Tampa | Tampa | Florida | 33613 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's | Atlanta | Georgia | 30342-5020 | — |
| Atlanta Gastroenterology Specialists | Suwanee | Georgia | 30024 | — |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Brigham And Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39202 | — |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Ohio State University Hospital | Hilliard | Ohio | 43026 | — |
| Northshore Gastroenterology Research, LLC | Westlake | Ohio | 44145 | — |
| Oklahoma Digestive Disease Specialists | Oklahoma City | Oklahoma | 73112 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Texas Digestive Disease Consultants | Cedar Park | Texas | 78613 | — |
| Baylor College of Medicine | Houston | Texas | 77025 | — |
| Houston Methodist Hospital | Houston | Texas | 77030-2740 | — |
| Gastroenterology Research of America, LLC | San Antonio | Texas | 78229 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| University of Washington | Seattle | Washington | 98195 | — |
| Washington Gastroenterology, PLLC | Tacoma | Washington | 98405 | — |
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 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03782376, 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 Apr 29, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03782376 live on ClinicalTrials.gov.