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NCT03345836 · ClinicalTrials.gov registry record · Phase 3

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

A Phase 3 study of Crohn's Disease, sponsored by AbbVie.

Completed
Registry status
Phase 3
Development phase
624
Enrollment target
20
Study locations

NCT03345836 is a Phase 3 study of Crohn's Disease that has completed, run by AbbVie. The registered enrollment target is 624 participants, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT03345836, a Phase 3 study of Crohn's Disease, has completed, sponsored by AbbVie.

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

Study Summary

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Conditions Studied

Interventions

  • DRUG Upadacitinib
  • DRUG Matching Placebo for Upadacitinib

Study Locations (20)

California

  • Southern California Res. Ctr. /ID# 169654 - Coronado
  • Citrus Valley Gastroenterology /ID# 166201 - Covina
  • United Medical Doctors /ID# 207452 - Los Alamitos
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164887 - Los Angeles
  • Facey Medical Foundation /ID# 203137 - Mission Hills
  • United Medical Doctors - Murrieta /ID# 164845 - Murrieta
  • Ucsd /Id# 164679 - San Diego
  • Medical Assoc Research Grp /ID# 169705 - San Diego
  • UCSF Center for Colitis and Crohn's Disease /ID# 202373 - San Francisco
  • Univ of California San Francis /ID# 164843 - San Francisco
  • Care Access Research /ID# 167766 - San Pablo

Arizona

  • Delsol Research Management, Ll /Id# 170179 - Chandler
  • HonorHealth Research Institute - Shea /ID# 164734 - Scottsdale
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 203891 - Sun City

Colorado

  • Peak Gastroenterology Associates, PC /ID# 170181 - Colorado Springs
  • Delta Waves, Inc. /ID# 164872 - Colorado Springs
  • Duplicate_Western States Clinical Research, Inc. /ID# 164895 - Wheat Ridge

Alabama

  • East View Medical Research, LLC /ID# 171133 - Mobile
  • CB Flock Research Corporation /ID# 166220 - Mobile

Connecticut

  • Medical Research Center of CT /ID# 164829 - Hamden

Trial Details

FieldValue
Enrollment Target 624 participants
Start Date 2017-11-29
Est. Completion 2021-08-11
Phase Phase 3

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT03345836

The ClinicalTrials.gov registry entry for NCT03345836 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 624 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,389-participant average among 105 other Crohn's Disease trials with a reported enrollment target (74% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Upadacitinib is the first listed.

NCT03345836 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT03345836 about?

NCT03345836 is a clinical study titled "A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy". The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

What is the current status of trial NCT03345836?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 624 participants. The study started on 2017-11-29. Estimated completion is 2021-08-11.

What conditions does trial NCT03345836 study?

This clinical trial studies the following conditions: Crohn's Disease.

What interventions are being tested in trial NCT03345836?

The interventions under investigation include: Upadacitinib (DRUG), Matching Placebo for Upadacitinib (DRUG).

Who is sponsoring clinical trial NCT03345836?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03345836 being conducted?

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

Similar trials for Crohn's Disease

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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.