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A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
NCT04232553 · View on ClinicalTrials.gov ↗
Study Summary
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
Conditions Studied
Interventions
- DRUG Mirikizumab
Study Locations (20)
Florida
- Gastroenterology Consultants of Clearwater — Clearwater
- Clinical Research of West Florida, Inc. (Clearwater) — Clearwater
- IHS Health Research — Kissimmee
- Ezy Medical Research — Miami
- Care Access - Orlando — Orlando
- Gastroenterology Associates of Pensacola, PA — Pensacola
- Precision Clinical Research — Sunrise
- USF Health — Tampa
- Alliance Clinical Research of Tampa — Tampa
California
- Care Access - Gilroy — Gilroy
- Newport Huntington Medical Group — Huntington Beach
- California Medical Research Associates — Northridge
Arizona
- Research Solutions of Arizona — Litchfield Park
- Arizona Arthritis & Rheumatology Research, PLLC — Phoenix
Georgia
- Digestive Healthcare of Georgia — Atlanta
- Gastrointestinal Specialists of Georgia — Marietta
Alabama
- Digestive Health Specialists — Dothan
Connecticut
- Connecticut Clinical Research Institute — Bristol
Idaho
- Grand Teton Research Group — Idaho Falls
Indiana
- Qualmedica Research, LLC — Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 996 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04232553
The ClinicalTrials.gov registry entry for NCT04232553 describes a study currently listed as active not recruiting. 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 996 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 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 1 intervention — of which Mirikizumab 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: NCT04232553 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Arizona. 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 NCT04232553 about?
NCT04232553 is a clinical study titled "A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease". The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
What is the current status of trial NCT04232553?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 996 participants. The study started on 2020-06-22. Estimated completion is 2027-04.
What conditions does trial NCT04232553 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 NCT04232553?
The interventions under investigation include: Mirikizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04232553?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04232553 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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