A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:4/5/2019
Start Date:October 19, 2018
End Date:March 22, 2022
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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A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as
maintenance therapy in participants who completed prior 12-week induction study AMAN
(NCT03518086).


Inclusion Criteria:

- Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and
without early termination of study drug.

- Are willing and able to complete the scheduled study assessments, including endoscopy
and daily diary entry.

- If female, must meet the contraception requirements.

Exclusion Criteria:

- Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified
(indeterminate colitis) during the induction study AMAN (NCT03518086).

- Participants with a bowel resection or other surgery for the treatment of UC during
the previous induction study AMAN (NCT03518086), or are likely to require surgery for
the treatment of UC during study AMBG.

- Participants with evidence of colonic dysplasia or have been diagnosed with cancer of
the gastrointestinal tract during study AMAN (NCT03518086).

- Participants diagnosed with clinically important infection including, but not limited
to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the
induction study AMAN (NCT03518086).

- Participants who initiate a new prohibited medication during the induction study AMAN
(NCT03518086).

- Participants with certain laboratory abnormalities prior to start of AMBG that would
require permanent discontinuation from study drug.
We found this trial at
132
sites
Novi, Michigan 48377
Principal Investigator: Nirmal Kaur
Phone: 313-916-3369
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112 Gainsborough Square
Chesapeake, Virginia 23320
757-547-0798
Principal Investigator: Felix P Tiongco
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2147 Northeast Coachman Road
Clearwater, Florida 33765
Principal Investigator: Leonard Jay Dunn
Phone: 7274660078
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Principal Investigator: Monte Troutman
Phone: 817-735-5474
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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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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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260 Lookout Pl # 201
Maitland, Florida 32751
Principal Investigator: Andria M Mushahwar
Phone: 321-295-7850
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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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2619 E. Pierce St.
Phoenix, Arizona 85008
602-344-5951
Principal Investigator: Keng-Yu Chuang
Phone: 602-344-5194
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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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Arcadia, California 91006
Principal Investigator: Elias A Tarakji
Phone: 626-963-2490
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Atlanta, Georgia 30309
Principal Investigator: Michael R Galambos
Phone: 678-686-5073
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Atlanta, Georgia 30342
Principal Investigator: Douglas C Wolf
Phone: 404-257-2138
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Aurora, Colorado 80045
Principal Investigator: Mark Gerich
Phone: 303-724-7244
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Austin, Texas 78731
Principal Investigator: Anurekha Chadha
Phone: 512-344-0362
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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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Baton Rouge, Louisiana 70809
Principal Investigator: Jonathon C Chapman
Phone: 225-927-1190
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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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950 Stoneridge Drive
Bozeman, Montana 59718
Principal Investigator: Andrew Gentry
Phone: 406-414-4475
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Burlington, Massachusetts 01805
Principal Investigator: Laurie Grossberg
Phone: 781-744-8740
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Camarillo, California 93012
Principal Investigator: karen Simon
Phone: 805-484-7921
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Catonsville, Maryland 21228
Principal Investigator: Vijay Narayen
Phone: 410-737-0053
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Chapel Hill, North Carolina 27599
Principal Investigator: Animesh Jain
Phone: 919-445-3880
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Chesterfield, Michigan 48098
Principal Investigator: Ronald P Fogel
Phone: 586-598-3329
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Stephen B Hanauer
Phone: 312-695-5878
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Cincinnati, Ohio 45219
Principal Investigator: Kevin M Cronley
Phone: 513-872-4549
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Ciudad Autonoma De Buenos Air, Buenos Aires
Principal Investigator: Emiliano Tron
Phone: 5491154287683
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Clearwater, Florida 33762
Principal Investigator: Michael Weiss
Phone: 727-336-7682
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Clive, Iowa 50325
Principal Investigator: Bernard l Leman
Phone: 515-225-6050
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Colorado Springs, Colorado 80918
Principal Investigator: Henry Scheuller
Phone: 719-262-9283
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Columbus, Georgia 31904
Principal Investigator: Ashwin Patel
Phone: 706-641-6900
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Covina, California 91722
Principal Investigator: Sartaj M Arora
Phone: 408-406-1004
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Dothan, Alabama 36305
Principal Investigator: Paul Lamb
Phone: 334-836-1212
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Edinburg, Texas 78539
Principal Investigator: Murthy Badiga
Phone: 956-973-2446
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Evanston, Illinois
Principal Investigator: Eugene F Yen
Phone: 847-570-3708
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Fall River, Massachusetts 02721
Principal Investigator: Frederick W Schnure
Phone: 508-679-6611
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Farmington Hills, Michigan 48334
Principal Investigator: Mariquit Sendelbach
Phone: 248-747-5831
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Flourtown, Pennsylvania 19031
Principal Investigator: Victor R Araya
Phone: 215-402-0800
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Garden Grove, California 92843
Principal Investigator: Michael D Kurtz
Phone: 855-229-1665
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Garland, Texas 75044
Principal Investigator: Harry Sarles
Phone: 972-265-8201
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Germantown, Tennessee 38138
Principal Investigator: Ziad H Younes
Phone: 901-507-6124
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Grafton, Wisconsin 53024
Principal Investigator: Lilani P Perera
Phone: 262-329-8100
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Great Neck, New York 11021
Principal Investigator: Blanche Fung Liu
Phone: 516-466-1051
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Great Neck, New York 11021
Principal Investigator: Keith Sultan
Phone: 516-387-3990
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Greenville, North Carolina 27834
Principal Investigator: PHILLIP J. GOLDSTEIN
Phone: 252-758-8181
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Hialeah Gardens, Florida 33016
Principal Investigator: Lucky Flores
Phone: 786-483-7856
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Hollywood, Florida 33021
Principal Investigator: Mark E Lamet
Phone: 954-893-9222
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Houston, Texas 77004
Principal Investigator: Nasir Ahmed
Phone: 713-333-9868
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19255 Park Row Drive
Houston, Texas 77084
Principal Investigator: James Arthur Maher
Phone: 2819443610
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Houston, Texas 77030
Principal Investigator: Bincy Abraham
Phone: 713-363-8890
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Idaho Falls, Idaho 83404
Principal Investigator: Clint E Behrend
Phone: 208-528-4256
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Indianapolis, Indiana 46202
Principal Investigator: Prodyot Ghosh
Phone: 812-333-5973
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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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Inverness, Florida 34452
Principal Investigator: Paul A Hellstern
Phone: 352-341-2100
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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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La Jolla, California 92037
Principal Investigator: Brigid Boland
Phone: 858-246-2572
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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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Lake Charles, Louisiana 70601
Principal Investigator: Ricardo McCall
Phone: 337-602-6642
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Lakewood Ranch, Florida 34211
Principal Investigator: Guy W Neff
Phone: 941-727-7772
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Lancaster, California 93534
Principal Investigator: Jatinder S Pruthi
Phone: 661-388-2239
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Las Vegas, Nevada 89113
Principal Investigator: Christian D Stone
Phone: 702-336-4118
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232-01 Merrick Boulevard
Laurelton, New York 11413
Principal Investigator: David Scott
Phone: 718-276-4750
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Lawrenceville, Georgia 30046
Principal Investigator: Bhuvan Indrakrishnan
Phone: 678-377-8252
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Leesburg, Virginia 20176
Principal Investigator: Satinder Gill
Phone: 703-723-3670
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106 Nate Whipple Highway
Lincoln, Rhode Island 02865
Principal Investigator: Scott Wilson
Phone: 401-475-7007
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Litchfield Park, Arizona 85340
Principal Investigator: Connie C Hsu
Phone: 623-512-4340
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Lynchburg, Virginia 24502
Principal Investigator: Larry E Clark
Phone: 434-455-8670
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Melrose Park, Illinois 60160
Principal Investigator: Kathleen A Ward
Phone: 708-274-1577
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6141 Sunset Drive
Miami, Florida 33143
Principal Investigator: Javier Sobrado
Phone: 786-476-8790
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Miami, Florida 33175
Principal Investigator: Jorge Paoli-Bruno
Phone: 708-362-6114
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Middleburg Heights, Ohio 44130
Principal Investigator: Mazen Issa
Phone: 440-816-4546
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2645 North Mayfair Road
Milwaukee, Wisconsin 53226
Principal Investigator: Samuel Idarraga
Phone: 414-727-8131
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Milwaukee, Wisconsin 53215
Principal Investigator: Daniel Geenen
Phone: 414-908-6630
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Minot, North Dakota 58701
Principal Investigator: Edmundo Justino
Phone: 701-857-2510
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Monroe, Louisiana 71201
Principal Investigator: Bal Raj Bhandari
Phone: 318-807-0819
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Montclair, California 91763
Principal Investigator: Rizwana H. Mohseni
Phone: 909-590-8409
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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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Naples, Florida 34110
Principal Investigator: William J Provance
Phone: 239-631-2989
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2630 Grant Line Road
New Albany, Indiana 47150
Principal Investigator: Matthew D McCollough
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New Brunswick, New Jersey 08903
Principal Investigator: Darren N Seril
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New Orleans, Louisiana 70112
Principal Investigator: Gregory P Gaspard
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New Orleans, Louisiana 70115
Principal Investigator: Vivek Huilgol
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New York, New York 10016
Principal Investigator: Alex Sherman
Phone: 212-889-5544
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New York, New York 10021
Principal Investigator: Ellen J Scherl
Phone: 212-746-5109
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New York, New York 10029
Principal Investigator: Jean F Colombel
Phone: 212-824-8100
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Norman, Oklahoma 73069
Principal Investigator: Robert A Gordon
Phone: 405-329-0474
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Northridge, California 91325
Principal Investigator: Saleem A Desai
Phone: 818-235-7104
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Northridge, California 91324
Principal Investigator: Calin Arimie
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Ogden, Utah 84403
Principal Investigator: Chad Gonzales
Phone: 801-614-5505
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Ogden, Utah 84405
Principal Investigator: John E Lowe
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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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Orlando, Florida 32804
Principal Investigator: Udayakumar Navaneethan
Phone: 407-303-2750
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Orlando, Florida 32807
Principal Investigator: Niaz Ausaf
Phone: 407-440-4493
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Palmetto Bay, Florida
Principal Investigator: Miguel Rodriguez
Phone: 786-310-7477
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Pasadena, California 91105
Principal Investigator: Glenn D Littenberg
Phone: 626-449-9920
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Pennington, New Jersey 08534
Principal Investigator: Anil R Balani
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Pensacola, Florida 32503
Principal Investigator: Frederic Newman
Phone: 850-477-8109
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Phoenix, Arizona 85012
Principal Investigator: Yasmin Alishahi
Phone: 901-219-7703
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Pikesville, Maryland 21208
Principal Investigator: Kenolisa C Onwueme
Phone: 410-602-7782
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4820 Park Boulevard North
Pinellas Park, Florida 33781
Principal Investigator: Tejinder S Glamour
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Marc Schwartz
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