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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
NCT03345849 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2017-12-07 |
| Est. Completion | 2022-01-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03345849
The ClinicalTrials.gov registry entry for NCT03345849 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 526 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03345849 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03345849?
The interventions under investigation include: Upadacitinib (DRUG), Placebo for Upadacitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03345849?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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