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 |
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.
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
Hialeah Gardens, Florida 33016
Principal Investigator: Lucky Flores
Phone: 786-483-7856
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112 Gainsborough Square
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
757-547-0798
Principal Investigator: Felix P Tiongco
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2147 Northeast Coachman Road
Clearwater, Florida 33765
Clearwater, Florida 33765
Principal Investigator: Leonard Jay Dunn
Phone: 7274660078
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
Fort Worth, Texas 76107
Principal Investigator: Monte Troutman
Phone: 817-735-5474
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1200 Moursund Street
Houston, Texas 77030
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
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
Maitland, Florida 32751
Principal Investigator: Andria M Mushahwar
Phone: 321-295-7850
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1211 Medical Center Dr
Nashville, Tennessee 37232
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
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
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
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
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
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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Catonsville, Maryland 21228
Principal Investigator: Vijay Narayen
Phone: 410-737-0053
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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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Chesterfield, Michigan 48098
Principal Investigator: Ronald P Fogel
Phone: 586-598-3329
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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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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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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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Hollywood, Florida 33021
Principal Investigator: Mark E Lamet
Phone: 954-893-9222
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19255 Park Row Drive
Houston, Texas 77084
Houston, Texas 77084
Principal Investigator: James Arthur Maher
Phone: 2819443610
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Idaho Falls, Idaho 83404
Principal Investigator: Clint E Behrend
Phone: 208-528-4256
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340 W 10th St #6200
Indianapolis, Indiana 46202
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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Indianapolis, Indiana 46202
Principal Investigator: Prodyot Ghosh
Phone: 812-333-5973
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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
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
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
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
Lincoln, Rhode Island 02865
Principal Investigator: Scott Wilson
Phone: 401-475-7007
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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
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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Milwaukee, Wisconsin 53215
Principal Investigator: Daniel Geenen
Phone: 414-908-6630
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2645 North Mayfair Road
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Principal Investigator: Samuel Idarraga
Phone: 414-727-8131
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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
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
New Albany, Indiana 47150
Principal Investigator: Matthew McCollough
Phone: 812-206-1702
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New Brunswick, New Jersey 08903
Principal Investigator: Darren N Seril
Phone: 732-235-7784
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New Orleans, Louisiana 70112
Principal Investigator: Gregory P Gaspard
Phone: 504-588-5405
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New Orleans, Louisiana 70115
Principal Investigator: Vivek Huilgol
Phone: 504-905-3260
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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 91324
Principal Investigator: Calin Arimie
Phone: 818-349-1974
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Northridge, California 91325
Principal Investigator: Saleem A Desai
Phone: 818-235-7104
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Novi, Michigan 48377
Principal Investigator: Nirmal Kaur
Phone: 313-916-3369
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Ogden, Utah 84405
Principal Investigator: John E Lowe
Phone: 801-409-2040
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Ogden, Utah 84403
Principal Investigator: Chad Gonzales
Phone: 801-614-5505
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940 NE 13th St
Oklahoma City, Oklahoma 73190
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 32807
Principal Investigator: Niaz Ausaf
Phone: 407-440-4493
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Orlando, Florida 32804
Principal Investigator: Udayakumar Navaneethan
Phone: 407-303-2750
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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
Phone: 609-537-5000
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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
Pinellas Park, Florida 33781
Principal Investigator: Tejinder S Glamour
Phone: 727-541-0200
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Marc Schwartz
Phone: 412-648-9173
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Plymouth, Minnesota 55446
Principal Investigator: Daniel M Van Handel
Phone: 612-870-5587
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