A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

ClinicalTrials.gov ID: NCT02407236

Public ClinicalTrials.gov record NCT02407236. 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.

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ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:33 PM 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, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

Study identification

NCT ID: NCT02407236
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Janssen Research & Development, LLC; Industry
Enrollment: 961 participants

Conditions and interventions

Conditions

Interventions

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: Jul 10, 2015 (Actual)
Primary completion: Aug 10, 2018 (Actual)
Completion: Nov 30, 2021 (Actual)
Last update posted: Apr 29, 2025

2015 – 2021

United States locations

U.S. sites: 68
U.S. states: 28
U.S. cities: 68

Facility	City	State	ZIP	Site status
Not listed	Birmingham	Alabama	—	—
Not listed	La Mirada	California	—	—
Not listed	Los Angeles	California	—	—
Not listed	Newport Beach	California	—	—
Not listed	Torrance	California	—	—
Not listed	Vallejo	California	—	—
Not listed	Lone Tree	Colorado	—	—
Not listed	Farmington	Connecticut	—	—
Not listed	Washington D.C.	District of Columbia	—	—
Not listed	Gainesville	Florida	—	—
Not listed	Largo	Florida	—	—
Not listed	Miami	Florida	—	—
Not listed	Port Orange	Florida	—	—
Not listed	Tampa	Florida	—	—
Not listed	Winter Park	Florida	—	—
Not listed	Zephyrhills	Florida	—	—
Not listed	Atlanta	Georgia	—	—
Not listed	Decatur	Georgia	—	—
Not listed	Macon	Georgia	—	—
Not listed	Suwanee	Georgia	—	—
Not listed	Idaho Falls	Idaho	—	—
Not listed	Chicago	Illinois	—	—
Not listed	Evanston	Illinois	—	—
Not listed	Urbana	Illinois	—	—
Not listed	Indianapolis	Indiana	—	—
Not listed	Pratt	Kansas	—	—
Not listed	Crestview Hills	Kentucky	—	—
Not listed	Lexington	Kentucky	—	—
Not listed	Louisville	Kentucky	—	—
Not listed	Houma	Louisiana	—	—
Not listed	Shreveport	Louisiana	—	—
Not listed	Columbia	Maryland	—	—
Not listed	Boston	Massachusetts	—	—
Not listed	Ann Arbor	Michigan	—	—
Not listed	Chesterfield	Michigan	—	—
Not listed	Troy	Michigan	—	—
Not listed	Ypsilanti	Michigan	—	—
Not listed	Rochester	Minnesota	—	—
Not listed	Jackson	Mississippi	—	—
Not listed	Marlton	New Jersey	—	—
Not listed	Morristown	New Jersey	—	—
Not listed	Brooklyn	New York	—	—
Not listed	Mineola	New York	—	—
Not listed	New York	New York	—	—
Not listed	Poughkeepsie	New York	—	—
Not listed	Rochester	New York	—	—
Not listed	The Bronx	New York	—	—
Not listed	Cincinnati	Ohio	—	—
Not listed	Mentor	Ohio	—	—
Not listed	Portland	Oregon	—	—
Not listed	Doylestown	Pennsylvania	—	—
Not listed	Hershey	Pennsylvania	—	—
Not listed	Philadelphia	Pennsylvania	—	—
Not listed	Sayre	Pennsylvania	—	—
Not listed	Germantown	Tennessee	—	—
Not listed	Nashville	Tennessee	—	—
Not listed	Dallas	Texas	—	—
Not listed	Houston	Texas	—	—
Not listed	Irving	Texas	—	—
Not listed	San Antonio	Texas	—	—
Not listed	Southlake	Texas	—	—
Not listed	Tyler	Texas	—	—
Not listed	Salt Lake City	Utah	—	—
Not listed	West Jordan	Utah	—	—
Not listed	Chesapeake	Virginia	—	—
Not listed	Fairfax	Virginia	—	—
Not listed	Roanoke	Virginia	—	—
Not listed	Seattle	Washington	—	—

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 179 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02407236, 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 21, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02407236 live on ClinicalTrials.gov.

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