An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:4/5/2019
Start Date:June 18, 2018
End Date:December 29, 2021
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:ClinicalTrials.gov@lilly.com
Phone:1-317-615-4559

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in
participants with moderately to severely active ulcerative colitis (UC) who have had an
inadequate response to, loss of response, or intolerant to conventional or biologic therapy
for UC.


Inclusion Criteria:

- Diagnosis of UC for at least 3 months prior to baseline.

- Confirmed diagnosis of moderately or severely active UC, as assessed by the modified
Mayo score (MMS).

- Demonstrated an inadequate response to, a loss of response to, or an intolerance to
conventional or to biologic therapy for UC.

- If female, must meet the contraception requirements.

Exclusion Criteria:

- Participants with a current diagnosis of Crohn's disease or inflammatory bowel
disease-unclassified (indeterminate colitis).

- Participants with a previous colectomy.

- Participants with current evidence of toxic megacolon.

- Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19
antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).
We found this trial at
130
sites
Care Access Research - Salt Lake City
1045 East 3900 South
Salt Lake City, Utah 84124
Principal Investigator: Peder J Pedersen
Phone: 801-263-3041
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Gastroenterology Associates of Tidewater
112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
Principal Investigator: Felix P Tiongco
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Chesapeake, VA
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Clinical Research of West Florida
2147 Northeast Coachman Road
Clearwater, Florida 33765
Principal Investigator: Leonard Jay Dunn
Phone: 7274660078
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Clearwater, FL
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University of North Texas Health Science Center
3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Principal Investigator: Monte Troutman
Phone: 817-735-5474
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Fort Worth, TX
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Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Jason K Hou
Phone: 713-798-8220
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Kinston Medical Specialists
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Principal Investigator: Kenneth L Johnson
Phone: 252-559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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Kinston, NC
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Center for Advanced Gastroenterology
260 Lookout Pl # 201
Maitland, Florida 32751
Principal Investigator: Andria M Mushahwar
Phone: 321-295-7850
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Maitland, FL
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Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Sara N Horst
Phone: 615-322-4643
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Maricopa Integrated Health System
2619 E. Pierce St.
Phoenix, Arizona 85008
602-344-5951
Principal Investigator: Keng-Yu Chuang
Phone: 602-344-5194
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Peter D Higgins
Phone: 734-615-4843
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Valley Gastroenterology Cnslts
Arcadia, California 91006
Principal Investigator: Elias A Tarakji
Phone: 626-963-2490
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Arcadia, CA
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Digestive Healthcare of Georgia
Atlanta, Georgia 30309
Principal Investigator: Michael R Galambos
Phone: 678-686-5073
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Atlanta, GA
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Atlanta Gastroenterology Assoc Southeastern Research
Atlanta, Georgia 30342
Principal Investigator: Douglas C Wolf
Phone: 404-257-2138
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Atlanta, GA
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University of Colorado
Aurora, Colorado 80045
Principal Investigator: Mark Gerich
Phone: 303-724-7244
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Austin Regional Clinic
Austin, Texas 78731
Principal Investigator: Anurekha Chadha
Phone: 512-344-0362
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Austin, TX
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University of Maryland Medical Center
22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Raymond Cross
Phone: 410-706-5943
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Texas Digestive Disease Consultants
Baton Rouge, Louisiana 70809
Principal Investigator: Jonathon C Chapman
Phone: 225-927-1190
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Baton Rouge, LA
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Mid Dakota Clinic, PC
900 E Broadway Ave
Bismarck, North Dakota 58501
(701) 530-5550
Principal Investigator: Mustafa Kathawala
Phone: 701-530-6957
Mid Dakota Clinic, PC We're your family clinic, with the doctors you know and trust...
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Bozeman Health Clinical Research
950 Stoneridge Drive
Bozeman, Montana 59718
Principal Investigator: Andrew Gentry
Phone: 406-414-4475
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Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Principal Investigator: Laurie Grossberg
Phone: 781-744-8740
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Digestive Disease Associates, PA
Catonsville, Maryland 21228
Principal Investigator: Vijay Narayen
Phone: 410-737-0053
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Univ of North Carolina
Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Animesh Jain
Phone: 919-445-3880
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Clinical Research Institute of Michigan,
Chesterfield, Michigan 48098
Principal Investigator: Ronald P Fogel
Phone: 586-598-3329
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Chesterfield, MI
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Northwestern Feinberg School of Medicine
Chicago, Illinois 60611
Principal Investigator: Stephen B Hanauer
Phone: 312-695-5878
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Chicago, IL
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Consultants for Clinical Research Inc.
Cincinnati, Ohio 45219
Principal Investigator: Kevin M Cronley
Phone: 513-872-4549
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Cincinnati, OH
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Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
Ciudad Autonoma De Buenos Air, Buenos Aires
Principal Investigator: Emiliano Tron
Phone: 5491154287683
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Gastro Florida
Clearwater, Florida 33762
Principal Investigator: Michael Weiss
Phone: 727-336-7682
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Iowa Digestive Disease Center
Clive, Iowa 50325
Principal Investigator: Bernard l Leman
Phone: 515-225-6050
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Clive, IA
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Delta Waves Sleep Disorders & Research Center
Colorado Springs, Colorado 80918
Principal Investigator: Henry Scheuller
Phone: 719-262-9283
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Gastrointestinal Diseases Research
Columbus, Georgia 31904
Principal Investigator: Ashwin Patel
Phone: 706-641-6900
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Columbus, GA
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Citrus Valley Health Partners
Covina, California 91722
Principal Investigator: Sartaj M Arora
Phone: 408-406-1004
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Covina, CA
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Digestive Health Specialists of the Southeast
Dothan, Alabama 36305
Principal Investigator: Paul Lamb
Phone: 334-836-1212
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Doctors Hospital at Renaissance Research Institute
Edinburg, Texas 78539
Principal Investigator: Murthy Badiga
Phone: 956-973-2446
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NorthShore University HealthSystem
Evanston, Illinois
Principal Investigator: Eugene F Yen
Phone: 847-570-3708
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NECCR Primacare Research, LLC
Fall River, Massachusetts 02721
Principal Investigator: Frederick W Schnure
Phone: 508-679-6611
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Detroit Clinical Research Center PC
Farmington Hills, Michigan 48334
Principal Investigator: Mariquit Sendelbach
Phone: 248-747-5831
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Hillmont Gastroenterology, P.C.
Flourtown, Pennsylvania 19031
Principal Investigator: Victor R Araya
Phone: 215-402-0800
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Valley View Internal Medicine
Garden Grove, California 92843
Principal Investigator: Michael D Kurtz
Phone: 855-229-1665
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Digestive Health Associates of Texas
Garland, Texas 75044
Principal Investigator: Harry Sarles
Phone: 972-265-8201
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Garland, TX
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Gastro One
Germantown, Tennessee 38138
Principal Investigator: Ziad H Younes
Phone: 901-507-6124
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Germantown, TN
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Aurora Medical Center - Grafton
Grafton, Wisconsin 53024
Principal Investigator: Lilani P Perera
Phone: 262-329-8100
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Nyu Langone Long Island Clinical Research Associates
Great Neck, New York 11021
Principal Investigator: Blanche Fung Liu
Phone: 516-466-1051
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Northwell Health
Great Neck, New York 11021
Principal Investigator: Keith Sultan
Phone: 516-387-3990
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Carolina Digestive Diseases
Greenville, North Carolina 27834
Principal Investigator: Phillip J Goldstein
Phone: 252-758-8181
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Greenville, NC
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Wellness Clinical Research, LLC
Hialeah Gardens, Florida 33016
Principal Investigator: Lucky Flores
Phone: 786-483-7856
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Center for Gastrointestinal Disorders
Hollywood, Florida 33021
Principal Investigator: Mark E Lamet
Phone: 954-893-9222
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Biopharma Informatic Inc.
19255 Park Row Drive
Houston, Texas 77084
Principal Investigator: James Arthur Maher
Phone: 2819443610
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GI Clinic
Houston, Texas 77004
Principal Investigator: Nasir Ahmed
Phone: 713-333-9868
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Houston Methodist
Houston, Texas 77030
Principal Investigator: Bincy Abraham
Phone: 713-363-8890
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Grand Teton Research Group
Idaho Falls, Idaho 83404
Principal Investigator: Clint E Behrend
Phone: 208-528-4256
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Indiana University School of Medicine
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Principal Investigator: Sashidhar V Sagi
Phone: 317-944-3332
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Indiana University Health
Indianapolis, Indiana 46202
Principal Investigator: Prodyot Ghosh
Phone: 812-333-5973
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Nature Coast Clinical Research
Inverness, Florida 34452
Principal Investigator: Paul A Hellstern
Phone: 352-341-2100
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Tuba Esfandyari
Phone: 913-588-6019
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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UC San Diego Altman Clinical and Translational Research Inst
La Jolla, California 92037
Principal Investigator: Brigid Boland
Phone: 858-246-2572
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The University of California, San Diego
9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: William J Sandborn
Phone: 858-246-2353
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Clinical Trials of SW Louisiana LLC
Lake Charles, Louisiana 70601
Principal Investigator: Ricardo McCall
Phone: 337-602-6642
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Florida Digestive Health Specialists
Lakewood Ranch, Florida 34211
Principal Investigator: Guy W Neff
Phone: 941-727-7772
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Om Research
Lancaster, California 93534
Principal Investigator: Jatinder S Pruthi
Phone: 661-388-2239
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Las Vegas Medical Research
Las Vegas, Nevada 89113
Principal Investigator: Christian D Stone
Phone: 702-336-4118
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Scott Research Center
232-01 Merrick Boulevard
Laurelton, New York 11413
Principal Investigator: David Scott
Phone: 718-276-4750
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Gwinnett Digestive Clinic PC
Lawrenceville, Georgia 30046
Principal Investigator: Bhuvan Indrakrishnan
Phone: 678-377-8252
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Lawrenceville, GA
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Emeritas Research Group
Leesburg, Virginia 20176
Principal Investigator: Satinder Gill
Phone: 703-723-3670
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Leesburg, VA
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Ocean State Clinical Research Partners
106 Nate Whipple Highway
Lincoln, Rhode Island 02865
Principal Investigator: Scott Wilson
Phone: 401-475-7007
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Dcr-Pi Pc
Litchfield Park, Arizona 85340
Principal Investigator: Connie C Hsu
Phone: 623-512-4340
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Blue Ridge Medical Research
Lynchburg, Virginia 24502
Principal Investigator: Larry E Clark
Phone: 434-455-8670
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Lemah Creek Clinical Research
Melrose Park, Illinois 60160
Principal Investigator: Kathleen A Ward
Phone: 708-274-1577
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Research Associates of South Florida, LLC
6141 Sunset Drive
Miami, Florida 33143
Principal Investigator: Javier Sobrado
Phone: 786-476-8790
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Coral Research Clinic corp
Miami, Florida 33175
Principal Investigator: Jorge Paoli-Bruno
Phone: 708-362-6114
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Paramount Medical Research
Middleburg Heights, Ohio 44130
Principal Investigator: Mazen Issa
Phone: 440-816-4546
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Wisconsin Center for Advanced Research
Milwaukee, Wisconsin 53215
Principal Investigator: Daniel Geenen
Phone: 414-908-6630
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Allegiance Research Specialists, LLC
2645 North Mayfair Road
Milwaukee, Wisconsin 53226
Principal Investigator: Samuel Idarraga
Phone: 414-727-8131
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Trinity Health Center - Medical Arts
Minot, North Dakota 58701
Principal Investigator: Edmundo Justino
Phone: 701-857-2510
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Minot, ND
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Delta Research Partners, LLC
Monroe, Louisiana 71201
Principal Investigator: Bal Raj Bhandari
Phone: 318-807-0819
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Monroe, LA
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Catalina Research Institute, LLC
Montclair, California 91763
Principal Investigator: Rizwana H. Mohseni
Phone: 909-590-8409
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Intermountain Medical Center
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Richard K Gilroy
Phone: 801-507-3380
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Pharma Research International, Inc
Naples, Florida 34110
Principal Investigator: William J Provance
Phone: 239-631-2989
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Naples, FL
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Aquiant Research
2630 Grant Line Road
New Albany, Indiana 47150
Principal Investigator: Matthew McCollough
Phone: 812-206-1702
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Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08903
Principal Investigator: Darren N Seril
Phone: 732-235-7784
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Tulane University School of Medicine
New Orleans, Louisiana 70112
Principal Investigator: Gregory P Gaspard
Phone: 504-588-5405
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New Orleans, LA
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Nola Research Works
New Orleans, Louisiana 70115
Principal Investigator: Vivek Huilgol
Phone: 504-905-3260
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New Orleans, LA
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Concord Medical Group PLLC
New York, New York 10016
Principal Investigator: Alex Sherman
Phone: 212-889-5544
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Weill-Cornell Medical College
New York, New York 10021
Principal Investigator: Ellen J Scherl
Phone: 212-746-5109
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Mount Sinai - PRIME
New York, New York 10029
Principal Investigator: Jean F Colombel
Phone: 212-824-8100
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Central Sooner Research
Norman, Oklahoma 73069
Principal Investigator: Robert A Gordon
Phone: 405-329-0474
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Norman, OK
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California Medical Research Group
Northridge, California 91324
Principal Investigator: Calin Arimie
Phone: 818-349-1974
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Machicado & Desai MDs
Northridge, California 91325
Principal Investigator: Saleem A Desai
Phone: 818-235-7104
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Henry Ford Health System
Novi, Michigan 48377
Principal Investigator: Nirmal Kaur
Phone: 313-916-3369
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Novi, MI
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Advanced Research Institute
Ogden, Utah 84405
Principal Investigator: John E Lowe
Phone: 801-409-2040
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Care Access Research - Salt Lake City
Ogden, Utah 84403
Principal Investigator: Chad Gonzales
Phone: 801-614-5505
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University of Oklahoma Health Sciences Center
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Richard F Harty
Phone: 405-271-5428
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Combined Research Orlando Phase I-IV LLC
Orlando, Florida 32807
Principal Investigator: Niaz Ausaf
Phone: 407-440-4493
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Center for Interventional Endoscopy
Orlando, Florida 32804
Principal Investigator: Udayakumar Navaneethan
Phone: 407-303-2750
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IMIC
Palmetto Bay, Florida
Principal Investigator: Miguel Rodriguez
Phone: 786-310-7477
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Gastroenterology Associates
Pasadena, California 91105
Principal Investigator: Glenn D Littenberg
Phone: 626-449-9920
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Capital Health Medical Center-Hopewell
Pennington, New Jersey 08534
Principal Investigator: Anil R Balani
Phone: 609-537-5000
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Gastroenterology Associates of Pensacola, PA
Pensacola, Florida 32503
Principal Investigator: Frederic Newman
Phone: 850-477-8109
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Phoenix VA Health Care System IRB
Phoenix, Arizona 85012
Principal Investigator: Yasmin Alishahi
Phone: 901-219-7703
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Woodholme Gastroenterology Associates PA
Pikesville, Maryland 21208
Principal Investigator: Kenolisa C Onwueme
Phone: 410-602-7782
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Theia Clinical Research
4820 Park Boulevard North
Pinellas Park, Florida 33781
Principal Investigator: Tejinder S Glamour
Phone: 727-541-0200
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University of Pittsburgh Medical Center Health System
Pittsburgh, Pennsylvania 15213
Principal Investigator: Marc Schwartz
Phone: 412-648-9173
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