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NCT03345849 · ClinicalTrials.gov registry record · Phase 3

A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

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

Completed
Registry status
Phase 3
Development phase
526
Enrollment target
20
Study locations

NCT03345849 is a Phase 3 study of Crohn's Disease that has completed, run by AbbVie. The registered enrollment target is 526 participants, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT03345849, a Phase 3 study of Crohn's Disease, has completed, sponsored by AbbVie.

COMPLETED
Registry status
Phase 3
Development phase
526 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 adults with moderately and severely active Crohn's disease (CD).

Conditions Studied

Interventions

  • DRUG Upadacitinib
  • DRUG Placebo for Upadacitinib

Study Locations (20)

California

  • Southern California Res. Ctr. /ID# 169655 - Coronado
  • Citrus Valley Gastroenterology /ID# 166173 - Covina
  • Hoag Memorial Hosp Presbyterian /ID# 222540 - Irvine
  • United Medical Doctors /ID# 207449 - Los Alamitos
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762 - Los Angeles
  • Facey Medical Foundation /ID# 203136 - Mission Hills
  • United Medical Doctors - Murrieta /ID# 164945 - Murrieta
  • Ucsd /Id# 164910 - San Diego
  • Medical Assoc Research Grp /ID# 169706 - San Diego
  • Univ of California San Francis /ID# 164944 - San Francisco
  • Care Access Research /ID# 167767 - San Pablo

Arizona

  • Delsol Research Management, Ll /Id# 170145 - Chandler
  • HonorHealth Research Institute - Shea /ID# 164821 - Scottsdale
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803 - Sun City

Colorado

  • Peak Gastroenterology Associates, PC /ID# 170143 - Colorado Springs
  • Delta Waves, Inc. /ID# 164776 - Colorado Springs
  • Western States Clinical Res /ID# 164760 - Wheat Ridge

Alabama

  • East View Medical Research, LLC /ID# 171176 - Mobile
  • CB Flock Research Corporation /ID# 166185 - Mobile

Connecticut

  • Medical Research Center of CT /ID# 164926 - Hamden

Trial Details

FieldValue
Enrollment Target 526 participants
Start Date 2017-12-07
Est. Completion 2022-01-13
Phase Phase 3

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT03345849

The ClinicalTrials.gov registry entry for NCT03345849 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 526 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (78% 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.

NCT03345849 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Arizona, Colorado.

Frequently Asked Questions

What is clinical trial NCT03345849 about?

NCT03345849 is a clinical study titled "A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies". The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

What is the current status of trial NCT03345849?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 526 participants. The study started on 2017-12-07. Estimated completion is 2022-01-13.

What conditions does trial NCT03345849 study?

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

What interventions are being tested in trial NCT03345849?

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

Who is sponsoring clinical trial NCT03345849?

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

Where is trial NCT03345849 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.

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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.