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NCT03345823 · ClinicalTrials.gov registry record · Phase 3
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433
A Phase 3 study of Crohn's Disease, sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 747
- Enrollment target
- 20
- Study locations
NCT03345823: Active Phase 3 study of Crohn's Disease, sponsored by AbbVie.
NCT03345823 is a Phase 3 study of Crohn's Disease that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 747 participants, below the 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03345823, a Phase 3 study of Crohn's Disease, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 747 participants
- Enrollment target
- 20
- Study locations
Study Summary
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
Primary Outcome
Clinical remission per CDAI is defined as CDAI \<150.
Conditions Studied
Interventions
- DRUG Upadacitinib
- DRUG Placebo for Upadacitinib
Study Locations (20)
California
- Southern California Res. Ctr. /ID# 169653 - Coronado
- Citrus Valley Gastroenterology /ID# 166230 - Covina
- Hoag Memorial Hosp Presbyterian /ID# 222538 - Irvine
- UC San Diego Health System /ID# 164763 - La Jolla
- United Medical Doctors /ID# 207458 - Los Alamitos
- Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164640 - Los Angeles
- Facey Medical Foundation /ID# 203138 - Mission Hills
- United Medical Doctors - Murrieta /ID# 164602 - Murrieta
- Medical Assoc Research Grp /ID# 169704 - San Diego
- UCSF Medical Center - Mount Zion /ID# 202372 - San Francisco
- Univ of California San Francis /ID# 164653 - San Francisco
- Care Access Research /ID# 167765 - San Pablo
Arizona
- Delsol Research Management, Ll /Id# 170164 - Chandler
- Duplicate_HonorHealth Research Institute - Shea /ID# 164725 - Scottsdale
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 164702 - Sun City
Colorado
- Peak Gastroenterology Associates, PC /ID# 170166 - Colorado Springs
- Delta Waves, Inc. /ID# 164656 - Colorado Springs
- Western States Clinical Res /ID# 164625 - Wheat Ridge
Alabama
- East View Medical Research, LLC /ID# 171132 - Mobile
- CB Flock Research Corporation /ID# 166239 - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 747 participants |
| Start Date | 2018-03-21 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What the registry record for NCT03345823 still lists
NCT03345823 is an interventional study that assigns participants to a tested intervention. The registered 747 participants enrollment target is mid-sized for trials with a published cap, below the 2,387-participant average among 105 other Crohn's Disease trials with a reported enrollment target (69% lower).
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.
NCT03345823 names 20 study sites across 4 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03345823 about?
NCT03345823 is a clinical study titled "A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433". A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
What is the current status of trial NCT03345823?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 747 participants. The study started on 2018-03-21. Estimated completion is 2027-09.
What conditions does trial NCT03345823 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT03345823?
The interventions under investigation include: Upadacitinib (DRUG), Placebo for Upadacitinib (DRUG).
Who is sponsoring clinical trial NCT03345823?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345823 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03345823's enrollment target sits among peer trials
747 17th of 105 higher than 89 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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