Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients
Public ClinicalTrials.gov record NCT01284062. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.
Study identification
- NCT ID
- NCT01284062
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 84 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2011 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- Apr 2013 (Actual)
- Last update posted
- Nov 18, 2014
2011 – 2013
United States locations
- U.S. sites
- 48
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Kirkland Clinic | Birmingham | Alabama | 35233 | — |
| UAB Hospital | Birmingham | Alabama | 35233 | — |
| UAB Hospital Department of Pharmacy | Birmingham | Alabama | 35249 | — |
| Administrative Offices | Birmingham | Alabama | 35294 | — |
| UAB ACIP | Birmingham | Alabama | 35294 | — |
| Arizona Surgical Center | Phoenix | Arizona | 85006 | — |
| Dedicated Phase I, Inc. | Phoenix | Arizona | 85013 | — |
| AGMG Endoscopy Center | Anaheim | California | 92801 | — |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| West Coast Radiology Center | Santa Ana | California | 92705 | — |
| Endoscopy Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| Gastroenterology Center of Connecticut, PC | Hamden | Connecticut | 06518 | — |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | — |
| International Clinical Research - US, LLC | Sanford | Florida | 32771 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| GI Diagnostics | Marietta | Georgia | 30067 | — |
| Gastrointestinal Associates, PA | Jackson | Mississippi | 39202 | — |
| Gastrointestional Associates, PA | Jackson | Mississippi | 39202 | — |
| St. Dominic Hospital | Jackson | Mississippi | 39216 | — |
| Digestive Health Specialists, PA | Tupelo | Mississippi | 38801 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| Premier Medical Group of the Hudson Valley | Poughkeepsie | New York | 12601 | — |
| Piedmont Gastroenterology Specialists | Winston-Salem | North Carolina | 27103 | — |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | — |
| University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease | Cleveland | Ohio | 44106 | — |
| Wheeler and Stuckey, Inc. | Oklahoma City | Oklahoma | 73103 | — |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | — |
| OU Physicians Building | Oklahoma City | Oklahoma | 73104 | — |
| Memphis Gastroenterology Group, PC | Germantown | Tennessee | 38138 | — |
| The West Clinic | Memphis | Tennessee | 38120 | — |
| Centennial Medical Center Physicians Park | Nashville | Tennessee | 37203 | — |
| Centennial Medical Center Tower Medical Imaging | Nashville | Tennessee | 37203 | — |
| Columbia Medical Group - The First Clinic Inc. | Nashville | Tennessee | 37203 | — |
| Radiology Alliance | Nashville | Tennessee | 37203 | — |
| Professional Quality Research, Inc. | Austin | Texas | 78705 | — |
| Austin Endoscopy Center | Austin | Texas | 78757 | — |
| Austin Gastroenterology, PA | Austin | Texas | 78757 | — |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | — |
| Austin Gastroenterology, PA | Round Rocks | Texas | 78681 | — |
| Cardiology Clinic of San Antonio | San Antonio | Texas | 78229 | — |
| Gastroenterology Research of San Antonio | San Antonio | Texas | 78229 | — |
| San Antonio Endoscopy Center | San Antonio | Texas | 78229 | — |
| CNS Pharmacy | Murray | Utah | 84123 | — |
| RGL Medical Services | Salt Lake City | Utah | 84084 | — |
| Alpine Medical Group | Salt Lake City | Utah | 84102 | — |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | — |
| Wasatch Endoscopy Center | Salt Lake City | Utah | 84124 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01284062, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 18, 2014 · Synced Nov 4, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01284062 live on ClinicalTrials.gov.