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NCT02782663 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
A Phase 2 study of Crohn's Disease (CD), sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT02782663: Completed Phase 2 study of Crohn's Disease (CD), sponsored by AbbVie.
NCT02782663 is a Phase 2 study of Crohn's Disease (CD) that has completed, run by AbbVie. The registered enrollment target is 107 participants, below the 170-participant average among 6 other Crohn's Disease (CD) trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02782663, a Phase 2 study of Crohn's Disease (CD), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
Primary Outcome
Endoscopic remission was based on Simplified Endoscopic Score for Crohn's disease (SES-CD). The SES-CD assessed the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. SES-CD was based on endoscopic findings in 5 bowel segments (Ileum, right colon, transverse colon, left colon/sigmoid, and rectum). Each item was scored 0 to 3 per segment. The sum of the scores for each endoscopic variable ranged from 0 to 15, except for stenosis, where it varied
Conditions Studied
Interventions
- DRUG ABT-494
Study Locations (20)
Florida
- Duplicate_University of Florida - Archer /ID# 150033 - Gainesville
- The Ctr for Gastro Disorders /ID# 150012 - Hollywood
- Nature Coast Clinical Research - Inverness /ID# 149975 - Inverness
California
- UC San Diego Health System /ID# 150041 - La Jolla
- Univ California, San Francisco /ID# 149987 - San Francisco
Georgia
- Gastroenterology Associates of Central Georgia, LLC /ID# 149870 - Macon
- GI Specialists of GA, PC /ID# 150015 - Marietta
Maryland
- Investigative Clinical Research /ID# 149886 - Annapolis
- Charm City Research Group /ID# 150040 - Towson
Missouri
- Kansas City Research Institute /ID# 149888 - Kansas City
- Washington University-School of Medicine /ID# 149899 - St Louis
New York
- NYU Langone Long Island Clinical Research Associates /ID# 149976 - Lake Success
- Weill Cornell Medicine/NYP /ID# 149895 - New York
Kansas
- Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900 - Topeka
Kentucky
- Duplicate_University of Louisville /ID# 149884 - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2016-05-18 |
| Est. Completion | 2025-07-18 |
| Phase | Phase 2 |
What the finished NCT02782663 record still lists
NCT02782663 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 170-participant average among 6 other Crohn's Disease (CD) trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Crohn's Disease (CD) appearing as the primary indexed condition, and to 1 intervention - of which ABT-494 is the first listed.
NCT02782663 names 20 study sites across 13 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT02782663 about?
NCT02782663 is a clinical study titled "A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease". This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
What is the current status of trial NCT02782663?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2016-05-18. Estimated completion is 2025-07-18.
What conditions does trial NCT02782663 study?
This clinical trial studies the following conditions: Crohn's Disease (CD).
What interventions are being tested in trial NCT02782663?
The interventions under investigation include: ABT-494 (DRUG).
Who is sponsoring clinical trial NCT02782663?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02782663 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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