Clinical Trial Details

NCT ID: NCT02819635
Date Last Changed: August 15, 2017


Research Study Summary

A Phase 2 clinical study for patients with Ulcerative Colitis (UC)

Research Study Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis


This study comprises three sub-studies. The objective of sub-study 1 is to characterize the dose-response, efficacy, and safety of ABT-494 compared to placebo in inducing clinical remission in order to identify the induction dose of ABT-494 for further evaluation in sub-study 2. The objective of sub-study 2 is to evaluate the efficacy and safety of ABT-494 compared to placebo in inducing clinical remission in participants. The objective of sub-study 3 is to evaluate the efficacy and safety of ABT-494 compared to placebo in achieving clinical remission in participants who had a response following induction with ABT-494.

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Recruitment Details

18 to 75 Years
Overall Status
Lead Sponsor
55 Months
Facility Type


All ages 18 Years to 75 Years

Inclusion Criteria:

  • Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.

  • Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).

  • Demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunosuppressants, and/or biologic therapies.

  • If female, participant must meet the criteria for Contraception Recommendations and Pregnancy Testing.

  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.

  • Male participants must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug.

Exclusion Criteria:

  • Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).

  • Current diagnosis of fulminant colitis and/or toxic megacolon.

  • Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.

  • Received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days prior to Baseline.

  • Participant on azathioprine or 6-mercaptopurine within 10 days of baseline.

  • Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.

  • Participant with previous exposure to JAK inhibitor (e.g., tofacitinib, baricitinib, filgotinib).

  • Screening laboratory and other analyses show any abnormal results.

Site Locations (191)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35209 Birmingham Gastroenterology Associates, P.C. /ID# 151276
United States Arizona Tucson 85712 Adobe Clinical Research LLC /ID# 155250
United States Arizona Tucson 85724 Banner - University Medical Center Tucson /ID# 150553
United States California Glendora 91740 S Paul Sharma Medical Corporation /ID# 151914
United States California Murrieta 92563 United Gastroenterologists /ID# 151211
United States California Oxnard 93030 Ventura County Gastroenterology Medical Group /ID# 163414
United States Colorado Colorado Springs 80918 Delta Waves, Inc. /ID# 151721
United States Colorado Lone Tree 80124 South Denver Gastroenterology, PC /ID# 151223
United States Colorado Wheat Ridge 80033 Western States Clinical Research, Inc. /ID# 158076
United States Connecticut Hamden 06518 Medical Research Center of Connecticut, LLC /ID# 150482
United States Florida Clearwater 33756 Gastro Florida /ID# 155245
United States Florida Doral 33166 Moonshine Research Center, Inc /ID# 152533
United States Florida Hialeah 33016 Palmetto Research, LLC /ID# 151716
United States Florida Inverness 34452 Nature Coast Clinical Research /ID# 154064
United States Florida Kissimmee 34759 SIH Research, LLC /ID# 163319
United States Florida Miami 33144 Crystal Pharmacology Research /ID# 151841
United States Florida Miami 33147 Advanced Pharma CR, LLC /ID# 151719
United States Florida Miami 33175 Coral Research Clinic Crop. /ID# 150444
United States Florida Miami 33175 New Horizon Research Center /ID# 152474
United States Florida New Port Richey 34653 Advanced Research Institute, Inc. /ID# 163098
United States Georgia Suwanee 30024 Atlanta Gastroenterology Specialists PC /ID# 150548
United States Illinois Evanston 60201 NorthShore University HealthSystem /ID# 150555
United States Illinois Hoffman Estates 60169 Northwest Health Care Associates /ID# 151590
United States Illinois Urbana 61801 Carle Foundation Hospital /ID# 151137
United States Indiana Evansville 47714 MediSphere Medical Research Center, LLC /ID# 152064
United States Louisiana Houma 70360 Houma Digestive Health Specialists /ID# 151844
United States Louisiana New Orleans 70125 Nola Research Works, LLC /ID# 153356
United States Louisiana Shreveport 71105 Louisiana Research Center, LLC /ID# 150446
United States Maryland Baltimore 21201 University of Maryland Medical Center /ID# 150449
United States Michigan Ann Arbor 48109 University of Michigan /ID# 151140
United States Michigan Troy 48098 Center for Digestive Health /ID# 161984
United States Michigan Wyoming 49519 Gastroenterology Associates, PA /ID# 157484
United States Michigan Ypsilanti 48197 Huron Gastroenterology Associates /ID# 152710
United States Minnesota Rochester 55905 Mayo Clinic /ID# 151677
United States Missouri Saint Louis 63110 Washington University School of Medicine /ID# 150485
United States Nevada Las Vegas 89113 Las Vegas Medical Research /ID# 153044
United States New Hampshire Lebanon 03756 Dartmouth-Hitchcock Medical Center /ID# 150549
United States New Jersey Egg Harbor City 8234 AGA Clinical Research Associates, LLC /ID# 153040
United States New Jersey Morristown 07960 Atlantic Digestive Health Institute at Morristown /ID# 150447
United States New York Brooklyn 11235 NY Scientific /ID# 152707
United States New York Poughkeepsie 12601 Premier Medical Group of the Hudson Valley, PC /ID# 153357
United States New York Rochester 14618 Gastroenterology Group of Rochester /ID# 151079
United States New York The Bronx 10467 Montefiore Medical Center /ID# 150543
United States New York The Bronx 10468 Advantage Clinical Trials /ID# 163938
United States North Carolina Charlotte 28204 Carolinas Healthcare System /ID# 156971
United States North Carolina Charlotte 28207-1200 Charlotte Gastroenterology and Hepatology, PLLC /ID# 150545
United States North Carolina Greenville 27834 AG Clinical Research, PLLC /ID# 151899
United States North Carolina Mount Airy 27030 Clinical Trials of America, Inc. /ID# 153448
United States Ohio Cincinnati 45219 Consultants for Clinical Research /ID# 151679
United States Ohio Mentor 44060 Ohio Clinical Research Partners /ID# 154068
United States Oklahoma Tulsa 74104 Options Health Research, LLC /ID# 150554
United States Oklahoma Tulsa 74135 Healthcare Research Consultants, LLC /ID# 163100
United States Oregon Portland 97210 Northwest Gastroenterology Clinic, LLC /ID# 152527
United States Pennsylvania Sayre 18840 Guthrie Medical Group, PC /ID# 150481
United States Pennsylvania State College 16803 Penn State Health Colonnade /ID# 150259
United States South Carolina Charleston 29412 Pharmacorp Clinical Trials Inc. /ID# 153354
United States South Carolina Greenville 29615 Gastroenterology Associates, PA /ID# 150541
United States Tennessee Germantown 38138 Gastro One /ID# 151144
United States Tennessee Nashville 37212-1375 Vanderbilt University Medical Center /ID# 153355
United States Texas Arlington 76012 Texas Clinical Research Institute, LLC /ID# 151526
United States Texas Channelview 77530 Aztec Clinical Research, Inc. /ID# 152062
United States Texas Richardson 75082 DHAT Research Institute /ID# 151218
United States Texas Temple 76508 Scott & White Memorial Hospital and Clinic /ID# 155193
United States Utah Ogden 84405 Advanced Research Institute /ID# 162624
United States Utah West Jordan 84088 Advanced Clinical Research /ID# 163181
United States Virginia Lansdowne Town Center 20176 Emeritas Research Group, LLC /ID# 150258
United States Virginia Petersburg 23805 Center for Gastrointestinal Health /ID# 153360
United States Washington Bellevue 98004 Northwest Gastroenterology Associates /ID# 163629
United States Washington Seattle 98101 Virginia Mason /ID# 153026
United States Washington Vancouver 98664 The Vancouver Clinic Inc. PS /ID# 162333
United States Wisconsin Milwaukee 53215 Wisconsin Center for Advanced Research GI Associates, LLC /ID# 151838
Australia Fitzroy, Melbourne 3065 St. Vincents Hospital Melbourne /ID# 152472
Austria Linz 4020 Krankenhaus der Elisabethinen Linz GmbH /ID# 150305
Austria Salzburg A-5020 LKH Salzburg /ID# 150306
Austria Vienna 1090 AKH Wien /ID# 150614
Belgium Leuven 3000 Universitair Ziekenhuis Leuven /ID# 150332
Belgium Roeselare 8800 AZ Delta /ID# 150330
Canada Greenfield Park J4V 2H1 Centre integre de services sociaux de la Monteregie-Centre /ID# 159215
Canada Hamilton L8S 4K1 McMaster University Medical Centre /ID# 150365
Canada Kelowna V1Y 1Z9 Okanagan Clinical Trials Ltd. /ID# 153178
Canada Montreal H1M 1B1 Recherche GCP Research /ID# 151822
Canada Sherbrooke J1G 2E8 Centre Hospitalier universitaire de Sherbrooke (CHUS) /ID# 150366
Canada Sudbury P3E 1H5 Medicor Research Inc. /ID# 151101
Canada Vaughan L4L 4Y7 Toronto Digestive Disease Associates, Inc. /ID# 150363
Czechia Hradec Kralove 500 12 Hepato-Gastroenterologie HK, s.r.o. /ID# 150912
Czechia Olomouc 779 00 CTCenter MaVe, s.r.o. /ID# 150904
Czechia Ostrava-Trebovice 722 00 Artroscan s.r.o. /ID# 150401
Czechia Prague 5 150 00 Axon Clinical, s.r.o. /ID# 152479
Estonia Tallinn 10617 West Tallinn Central Hospital /ID# 150419
Estonia Tallinn 13419 North Estonia Medical Centre Foundation /ID# 160870
Finland Helsinki 00290 helsingin Seudun yliopistollinen Keskussairaala /ID# 150407
Finland Jyvaskyla 40620 Keski-Suomen Keskussairaala /ID# 155666
Finland Mikkeli 50100 Laakarikeskus Ikioma /ID# 150121
Finland Tampere 33520 Tampere University Hospital /ID# 150114
Germany Berlin 10825 Praxis am Bayerischen Platz /ID# 150766
Germany Mannheim 68167 Universitatsklinikum Mannheim /ID# 150173
Germany Tuebingen 72076 Universitatsklinikum Tubingen /ID# 150767
Germany Wiesbaden 65189 Gastro Data Wiesbaden /ID# 150166
Greece Athens 10676 General Hospital of Athens, Evangelismos /ID# 150309
Greece Heraklion, Crete 71110 University Hospital of Heraklion /ID# 150250
Hungary Bekescsaba 5600 Bekes Megyei Kozponti Korhaz /ID# 151572
Hungary Budapest 1088 Semmelweis Egyetem /ID# 150312
Hungary Kecskemet 6000 Meditres Kft. /ID# 151521
Hungary Sopron 9400 Soproni Erzsebet Oktato Korhaz /ID# 151523
Hungary Szombathely 9700 Markusovszky Egyetemi Oktatokorhaz /ID# 150313
Ireland Dublin 9 Beaumont Hospital /ID# 150321
Israel Beer Sheva 85025 Soroka Medical Center /ID# 156561
Israel Haifa 3109601 Rambam Medical Center /ID# 150325
Italy Bologna 40138 Azienda Ospedale Policlinico Sant Orsola Malpighi /ID# 150337
Italy Milano 20122 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150334
Italy Milan 20121 Ospedale Fatebenefratelli e Oftalmico /ID# 150602
Italy Palermo 90146 A.O. Ospedali Riuniti Villa Sofia-Cervello /ID# 150253
Japan Aichi Nagoya University Hospital /ID# 152709
Japan Fukuoka-shi Kyushu University Hospital /ID# 152526
Japan Hachioji-shi Tokai University Hachioji Hospital /ID# 152587
Japan Higashiibaraki-gun National Hospital Organization Mito Medical Center /ID# 152631
Japan Hirosaki-shi, Aomori Hirosaki National Hospital /ID# 152763
Japan Hiroshima Hiroshima University Hospital /ID# 151951
Japan Kitakyushu-shi, Fukuoka Kitakyushu Municipal Medical Center /ID# 152588
Japan Kobe-shi Aoyama Clinic /ID# 152049
Japan Kofu-shi Yamanashi Prefectural Central Hospital /ID# 151908
Japan Kurume-shi,Fukuoka Kurume University Hospital /ID# 151976
Japan Kyoto Japanese Red Cross Kyoto Daiichi Hospital /ID# 152359
Japan Mitaka-shi Kyorin University Hospital /ID# 153194
Japan Nagakute-shi Aichi Medical University Hospital /ID# 151993
Japan Nagoya-shi Nagoya City University Hospital /ID# 151950
Japan Nishinomiya-shi Hyogo College of Medicine Hospital /ID# 152434
Japan Okayama, Kurashiki-shi Chikuba Hospital /ID# 157821
Japan Osaka-shi, Osaka Osaka City University Hospital /ID# 152682
Japan Osaka-shi Osaka City General Hospital /ID# 152704
Japan Saitama Saitama Medical Center /ID# 152031
Japan Saitama Tokito Clinic /ID# 152677
Japan Sapporo-shi Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital /ID# 151506
Japan Sunto-gun, Shizuoka National Hospital Organization Shizuoka Medical Center /ID# 163572
Japan Tokyo Kitasato University Kitasato Institute Hospital /ID# 152686
Japan Tokyo Medical Hospital of Tokyo Medical and Dental University /ID# 152016
Japan Toyota-shi, Aichi Ieda Hospital /ID# 157781
Korea, Republic of Busan 49201 Dong-A University Hospital /ID# 159480
Korea, Republic of Busan 49241 Pusan National University Hospital /ID# 159481
Korea, Republic of Daegu 42415 Yeungnam University Medical Center /ID# 150345
Korea, Republic of Guri-si, Gyeonggi-do 11923 Hanyang University Guri Hospital /ID# 150344
Korea, Republic of Paldal-gu, Suwon,Gyeonggi-do 16247 St. Vincent's Hospital /ID# 150347
Korea, Republic of Seoul 03181 Kangbuk Samsung Hospital /ID# 150348
Korea, Republic of Seoul 03722 Severance Hospital /ID# 159478
Korea, Republic of Seoul 05505 Asan Medical Center /ID# 150900
Korea, Republic of Seoul 06351 Samsung Medical Center /ID# 150346
Latvia Riga LV-1002 Pauls Stradins Clinical University Hospital /ID# 151409
Latvia Riga LV-1038 Riga East Clinical University Hospital /ID# 150354
Malaysia Alor Setar 05460 Hospital Sultanah Bahiyah /ID# 151687
Malaysia Ampang, Selangor Darul Ehsan 68000 Hospital Ampang /ID# 151298
Malaysia Kuala Lumpur, Wilayah Persekut 59100 University of Malaya Medical Centre /ID# 150359
Netherlands Amsterdam 1105 AZ Academisch Medisch Centrum /ID# 150647
Netherlands Leiden 2333 Leids Universitair Medisch Centrum /ID# 152624
Netherlands Nijmegen 6525 GA UMC St. Radboud /ID# 151700
Netherlands Rotterdam 3015 CE Erasmus Medisch Centrum /ID# 150308
Netherlands Utrecht 3584 CX UMC Utrecht /ID# 152775
Norway Nordbyhagen 1474 Akershus Universitetssykehus /ID# 150317
Norway Oslo 0450 Oslo University Hospital (OUS) /ID# 150856
Norway Tromso 9038 Universitetssykehuset Nord-Norge HF /ID# 152835
Poland Sopot 81-756 Endoskopia Sp. z o.o. /ID# 150765
Poland Warsaw 00-632 Centrum Zdrowia Matki Dziecka I Mlodziezy /ID# 150351
Poland Warsaw 02-018 Zespol Przychodni Specjalistycznych Prima Sp. Z O.O. /Id# 150580
Portugal Almada 2805-267 Hospital Garcia de Orta, E.P.E /ID# 151613
Portugal Braga 4710-243 Hospital de Braga /ID# 151608
Portugal Guimaraes 4835-044 Hospital Senhora Da Oliveira Gulmaraes, EPE /ID# 151607
Portugal Lisbon 1169-050 Centro Hospitalar de Lisboa Central, EPE /ID# 151611
Portugal Lisbon 1649-035 Centro Hospitalar de Lisbon Norte, EPE /ID# 151606
Portugal Porto 4200-319 Centro Hospitalar de Sao Joao, E.P.E.(CHSJ-HSJ) /ID# 151610
Portugal Santa Maria da Feira 4520-211 Centro Hospitalar de Entre o Douro e Vouga, EPE /ID# 152335
Puerto Rico San Juan 00935 University of Puerto Rico, School of Medicine /ID# 150358
Russian Federation Moscow 127015 City Clinical Hospital 24 /ID# 150395
Russian Federation Perm 614000 Perm Clinical Center of FMBA /ID# 150386
Russian Federation Stavropol 355017 Stavropol State Medical University /ID# 150387
Slovakia Banska Bystrica 975 17 Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bys /ID# 150868
Slovakia Bratislava 85101 Medak s.r.o., gastroenterologicka ambulancia /ID# 150480
Slovakia Ilava 019 01 Slovak Research Center Team Member /ID# 150257
Slovakia Kosice 04022 B and B MED s.r.o. /ID# 150471
Slovakia Presov 080 01 Gastro I.S.R.O. /ID# 150472
Sweden Gothenburg 413 46 Magtarmmottagningen /ID# 151496
Switzerland Basel CH-4031 Universitaetsspital Basel /ID# 161731
Switzerland Gallen CH-9007 Kantonsspital St. Gallen /ID# 152599
Switzerland Zurich 8091 Universitaetsspital Zurich /ID# 152591
Taiwan Kaohsiung 807 Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 150575
Taiwan Taichung City 40447 China Medical University Hospital /ID# 150571
Taiwan Taichung 40201 Chung Shan Medical University /ID# 150573
Taiwan Tainan 70403 National Cheng Kung University Hospital /ID# 151749
Taiwan Taipei 100 10041 National Taiwan University Hospital /ID# 150574
Taiwan Taipei City 11217 Taipei Veterans General Hospital /ID# 151748
United Kingdom Basingstoke RG24 9NA Basingstoke & North Hampshire Hospitel /ID# 150380
United Kingdom Exeter EX2 5DW RD&E Hospital /ID# 150379
United Kingdom London E1 2AT The Royal London Hospital /ID# 150384


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