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NCT02407236 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Inflammatory Bowel Diseases and Colitis, Ulcerative, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
961
Enrollment target
20
Study locations

NCT02407236 is a Phase 3 study of Inflammatory Bowel Diseases and Colitis, Ulcerative that has completed, run by Janssen Research & Development. The registered enrollment target is 961 participants, below the 42,241-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT02407236, a Phase 3 study of Inflammatory Bowel Diseases and Colitis, Ulcerative, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
961 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Inflammatory Bowel Diseases Colitis, Ulcerative

Interventions

  • DRUG Placebo IV
  • DRUG Placebo SC
  • DRUG Ustekinumab IV
  • DRUG Ustekinumab SC

Study Locations (20)

Florida

  • - Gainesville
  • - Largo
  • - Miami
  • - Port Orange
  • - Tampa
  • - Winter Park
  • - Zephyrhills

California

  • - La Mirada
  • - Los Angeles
  • - Newport Beach
  • - Torrance
  • - Vallejo

Georgia

  • - Atlanta
  • - Decatur
  • - Macon
  • - Suwanee

Alabama

  • - Birmingham

Colorado

  • - Lone Tree

Connecticut

  • - Farmington

District of Columbia

  • - Washington D.C.

Trial Details

FieldValue
Enrollment Target 961 participants
Start Date 2015-07-10
Est. Completion 2021-11-30
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02407236

The ClinicalTrials.gov registry entry for NCT02407236 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 961 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 42,241-participant average among 48 other Inflammatory Bowel Diseases trials with a reported enrollment target (98% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Inflammatory Bowel Diseases appearing as the primary indexed condition, and to 4 interventions - of which Placebo IV is the first listed.

NCT02407236 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT02407236 about?

NCT02407236 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis". 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 ...

What is the current status of trial NCT02407236?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 961 participants. The study started on 2015-07-10. Estimated completion is 2021-11-30.

What conditions does trial NCT02407236 study?

This clinical trial studies the following conditions: Inflammatory Bowel Diseases, Colitis, Ulcerative.

What interventions are being tested in trial NCT02407236?

The interventions under investigation include: Placebo IV (DRUG), Placebo SC (DRUG), Ustekinumab IV (DRUG), Ustekinumab SC (DRUG).

Who is sponsoring clinical trial NCT02407236?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02407236 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.