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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: Completed Phase 3 study of Crohn's Disease, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of
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
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2022-01-13 |
| Phase | Phase 3 |
What the finished NCT03345849 record still lists
NCT03345849 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, below the 2,390-participant average among 105 other Crohn's Disease trials with a reported enrollment target (78% 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.
NCT03345849 names 20 study sites across 5 states, led by 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.
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 NCT03345849's enrollment target sits among peer trials
526 24th of 105 higher than 82 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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