Clinical Trial Details

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

Overview

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

Purpose

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.

To Learn more

Recruitment Details

Phase
2
Gender
All
Age
18 to 75 Years
Overall Status
Recruiting
Lead Sponsor
AbbVie
Duration
55 Months
Facility Type
N/A
Compensation

Eligibility

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

Contact

AbbVie_Call Center
847-283-8955
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.