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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

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ClinicalTrials.gov Identifier: NCT02365649
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) therapy.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: ABT-494 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy
Study Start Date : March 17, 2015
Actual Primary Completion Date : November 25, 2016
Actual Study Completion Date : August 4, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Induction Period ABT-494 Low Dose
Induction Period ABT-494 Low Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

Active Comparator: Induction Period ABT-494 Low/Medium Dose
Induction Period ABT-494 Low/Medium Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

Active Comparator: Induction Period ABT-494 Twice Daily Medium/High Dose
Induction Period ABT-494 Twice Daily Medium/High Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

Active Comparator: Induction Period ABT-494 High Dose
Induction Period ABT-494 High Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

Active Comparator: Induction Period ABT-494 Once Daily Medium/High Dose
Induction Period ABT-494 Once Daily Medium/High Dose orally dosed once a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

Placebo Comparator: Induction Period Placebo
Induction Period Placebo orally dosed twice a day
Drug: Placebo
Oral Dosing

Active Comparator: Extension Phase ABT-494 Low Dose
Extension Phase ABT-494 Low Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

Active Comparator: Extension Phase ABT-494 Medium Dose
Extension Phase ABT-494 Medium Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib

Active Comparator: Extension Phase ABT-494 High Dose
Extension Phase ABT-494 High Dose orally dosed twice a day
Drug: ABT-494
Oral Dosing
Other Name: Upadacitinib




Primary Outcome Measures :
  1. Proportion of subjects who achieve endoscopic remission [ Time Frame: Up to Week 16 ]
    Endoscopic remission will be determined using Simplified Endoscopic Score for Crohn's Disease (SES-CD).

  2. Proportion of subjects who achieve clinical remission [ Time Frame: Week 16 ]
    Clinical remission to be determined at Week16


Secondary Outcome Measures :
  1. Proportion of subjects who achieve Crohn's Disease Activity Index (CDAI) less than 150 [ Time Frame: Week 16 ]
    Outcome to be measured by using CDAI

  2. Proportion of subjects with decrease in CDAI greater than or equal to 70 points [ Time Frame: Up to Week 16 ]
    Outcome to be measured by using CDAI

  3. Proportion of subjects who achieve remission at Week 52 [ Time Frame: Week 52 ]
    Remission to be determined at Week 52



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Crohn's disease (CD) for at least 90 days.
  2. Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450.
  3. Subject inadequately responded to or experience intolerance to previous treatment with immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate) and/or anti-TNF agent (e.g., infliximab, adalimumab, or certolizumab pegol).

Exclusion Criteria:

  1. Subjects with ulcerative colitis (UC), collagenous colitis or indeterminate colitis.
  2. Subject who has had surgical bowel resections in the past 6 months or is planning resection.
  3. Subjects with an ostomy or ileoanal pouch.
  4. Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
  5. Subject who has short bowel syndrome.
  6. Subject with recurring infections or active Tuberculosis (TB).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365649


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Locations
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United States, California
University of California San Diego Health System /ID# 136868
La Jolla, California, United States, 92093
Community Clinical Trials, Orange, CA /ID# 133110
Orange, California, United States, 92868
University of California, San Francisco /ID# 137841
San Francisco, California, United States, 94143
United States, Colorado
Rocky Mountain Clinical Research, LLC /ID# 133116
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Florida Research Network, LLC /ID# 142856
Gainesville, Florida, United States, 32605
University of Florida /ID# 144834
Gainesville, Florida, United States, 32608
The Center for Gastrointestinal Disorders /ID# 136728
Hollywood, Florida, United States, 33021
Nature Coast Clinical Research /ID# 137225
Inverness, Florida, United States, 34452
Center for Advanced Gastroenterology /ID# 136751
Maitland, Florida, United States, 32751
University of Miami /ID# 136729
Miami, Florida, United States, 33136
Gastroenterology Group of Naples /ID# 133647
Naples, Florida, United States, 34102
Internal Medicine Specialists /ID# 133102
Orlando, Florida, United States, 32806
Shafran Gastroenterology Center, Winter Park, FL /ID# 133128
Winter Park, Florida, United States, 32789
United States, Georgia
Tri County Research, Inc. /ID# 137309
Athens, Georgia, United States, 30606-6028
Gastroenterology Associates of Central Georgia, LLC /ID# 132959
Macon, Georgia, United States, 31201
Gastrointestinal Specialists of Georgia /ID# 142290
Marietta, Georgia, United States, 30060
United States, Illinois
Carle Cancer Center /ID# 132954
Urbana, Illinois, United States, 61801
United States, Kansas
Cotton-O'Neil Clinical Research Center /ID# 133132
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Louisville, MDA /ID# 133109
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University Health Sciences Center-Shreveport /ID# 144437
Shreveport, Louisiana, United States, 71103
Louisiana Research Center, LLC /ID# 144066
Shreveport, Louisiana, United States, 71105
United States, Maryland
Investigative Clinical Research /ID# 133111
Annapolis, Maryland, United States, 21401
MGG Group, Inc. /ID# 132955
Chevy Chase, Maryland, United States, 20815
Charm City Research Group /ID# 147049
Towson, Maryland, United States, 21204
United States, Michigan
Center for Digestive Health /ID# 133645
Troy, Michigan, United States, 48098
United States, Minnesota
Minnesota Gastroenterology, P.A. /ID# 136869
Plymouth, Minnesota, United States, 55446
Mayo Clinic /ID# 133121
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center /ID# 144264
Jackson, Mississippi, United States, 39216
United States, Missouri
Kansas City Research Institute /ID# 133113
Kansas City, Missouri, United States, 64131
Washington University School of Medicine /ID# 133130
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Langone Long Island Clinical Research Assoc., LLP /ID# 137226
Great Neck, New York, United States, 11021
Weill Cornell Medical College of Cornell University /ID# 133126
New York, New York, United States, 10021
United States, North Carolina
University of North Carolina at Chapel Hill /ID# 137308
Chapel Hill, North Carolina, United States, 27599-7080
Charlotte Gastroenterology and Hepatology, PLLC /ID# 133118
Charlotte, North Carolina, United States, 28207-1200
Wake Forest University Health Sciences /ID# 137837
Winston-Salem, North Carolina, United States
United States, Ohio
Consultants for Clinical Research /ID# 144081
Cincinnati, Ohio, United States, 45219
University of Cincinnati Physicians /ID# 137227
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
Options Health Research, LLC /ID# 133649
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
PMA Medical Specialist, LLC /ID# 136750
Limerick, Pennsylvania, United States, 19468
United States, South Carolina
Medical University of South Carolina /ID# 143678
Charleston, South Carolina, United States, 29425
Gastroenterology Associates, PA /ID# 143799
Greenville, South Carolina, United States, 29615
United States, Tennessee
Gastro One /ID# 136747
Germantown, Tennessee, United States, 38138
United States, Texas
The University of Texas Health Sciences Center at Houston /ID# 142054
Houston, Texas, United States, 77030
Texas Digestive Disease Consultants /ID# 132958
Southlake, Texas, United States, 76092
Texas Digestive Disease Consultants /ID# 138281
Southlake, Texas, United States, 76092
United States, Utah
Aspen Clinical Research /ID# 144065
Orem, Utah, United States, 84058
United States, Virginia
University of Virginia Health System /ID# 133104
Charlottesville, Virginia, United States, 22908
Carilion Medical Center /ID# 137317
Roanoke, Virginia, United States, 24016
United States, Washington
University of Washington /ID# 137843
Seattle, Washington, United States, 98195
United States, Wisconsin
Wisconsin Center for Advanced Research GI Associates, LLC /ID# 132952
Milwaukee, Wisconsin, United States, 53215
Allegiance Research Specialists /ID# 136752
Wauwatosa, Wisconsin, United States, 53226
Australia
Concord Repatriation and General Hospital /ID# 133172
Concord, Australia, 2139
Royal Brisbane and Women's Hospital /ID# 138163
Herston, Australia, 4029
Belgium
Universitair Ziekenhuis Leuven /ID# 133176
Leuven, Belgium, 3000
CHU Sart Tilman /ID# 133174
Liege, Belgium, 4000
AZ Delta /ID# 133175
Roeselare, Belgium, 8800
Canada
University of Alberta /ID# 133093
Edmonton, Canada, T6G 2X8
London Health Sciences Centre /ID# 133092
London, Canada, N6A 5A5
McGill University Health Center (MUHC) /ID# 133088
Montreal, Canada, H3G 1A4
Medicor Research Inc. /ID# 144833
Sudbury, Canada, P3E 1H5
The Gordon and Leslie Diamond Centre /ID# 133095
Vancouver, Canada, V5Z 1M9
GIRI Gastrointestinal Research Institute /ID# 137416
Vancouver, Canada, V6Z-2K5
Toronto Digestive Disease Associates /ID# 133098
Vaughan, Canada, L4L 4Y7
Winnipeg Regional Health Authority, HSC Winnipeg /ID# 132947
Winnipeg, Canada, R3A 1R9
Czechia
Hepato-Gastroenterologie HK, s.r.o. /ID# 139429
Hradec Kralove, Czechia, 50012
Fakultni Nemocnice v Motole /ID# 133181
Prague 5, Czechia, 150 06
Denmark
Aarhus University Hospital /ID# 133184
Aarhus C, Denmark, 8000
Hvidovre Hospital /ID# 139431
Hvidovre, Denmark, 2650
Odense University Hospital /ID# 133186
Odense, Denmark, 5000
France
CHU Amiens Picardie /ID# 133189
Amiens Cedex 1, France, 80054
CHRU de Lille, Hopital Claude Huriez /ID# 139432
Lille Cedex, France, 59037
Hopital Archet 2 /ID# 133191
Nice Cedex 3, France, 06202
Centre Hospitalier Univeritaire de Nancy /ID# 138165
Vandoeuvre Les Nancy Cedex, France, 54500
Germany
Charite Universitatesmedizin Berlin, CCM /ID# 133194
Berlin, Germany, 13353
DRK-Kliniken Westend /ID# 145864
Berlin, Germany, 14050
Universitaetsklinikum Erlangen /ID# 142841
Erlangen, Germany, 91054
Asklepios Westklinikum Hamburg /ID# 138166
Hamburg, Germany, 22559
Universitaetsklinikum Jena /ID# 133193
Jena, Germany, 07747
Universitaetsklinikum Schleswig-Holstein /ID# 133198
Kiel, Germany, 24105
Medizinisches Versorgungszentrum Portal 10 /ID# 133195
Muenster, Germany, 48155
Gastroenterologische Gemeinschaftspraxis /ID# 133196
Munster, Germany, 48159
Hungary
Magyar Elhizastudomanyi Kozpont Kft. /ID# 138167
Budapest, Hungary, 1076
Pannonia Maganorvosi Centrum Kft /ID# 133200
Budapest, Hungary, 1136
Petz Aladar Megyei Oktato Korhaz /ID# 133199
Gyor, Hungary, 9023
Israel
Rambam Health Care Campus /ID# 133204
Haifa, Israel, 31096
Rabin Medical Center /ID# 133201
Petah Tikva, Israel, 4941492
The Chaim Sheba Medical Center /ID# 133203
Ramat Gan, Israel, 52621
Assaf Harofeh Medical Center /ID# 133202
Zerifin, Be'er Ya'akov, Israel, 6093000
Italy
Azienda Ospedale Policlinico Sant Orsola Malpighi /ID# 133206
Bologna, Italy, 40138
Azienda Ospedaliero- Universitaria Mater Domini /ID# 139437
Catanzaro, Italy, 88100
Azienda Ospedaliera San Camillo Forlanini /ID# 139436
Rome, Italy, 00152
Universita Cattolica del Sacro Cuore /ID# 133205
Rome, Italy, 00168
Netherlands
Academic Medical Center Amsterdam /ID# 139439
Amsterdam, Netherlands, 1105 AZ
Erasmus Medisch Centrum /ID# 133207
Rotterdam, Netherlands, 3015 CE
UMC Utrecht /ID# 139440
Utrecht, Netherlands, 3584 CX
New Zealand
Southern District Health Board /ID# 133292
Dunedin, New Zealand, 9016
Norway
Akershus University Hospital /ID# 133299
Nordbyhagen, Norway, N-1474
Lovisenberg Diakonale Sykehus /ID# 133296
Oslo, Norway, 0456
Poland
Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 133302
Lodz, Poland, 90-302
Centrum Zdrowia Matki Dziecka I Mlodziezy /ID# 143340
Warsaw, Poland, 00-632
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 133301
Warsaw, Poland, 02-507
Puerto Rico
University of Puerto Rico, School of Medicine /ID# 132950
San Juan, Puerto Rico, 00935
Romania
Spitalul Clinic Colentina /ID# 133304
Bucharest, Romania, 020125
University Emergency Hospital Bucharest /ID# 133309
Bucharest, Romania, 050098
Algomed Policlinic /ID# 133307
Timisoara, Romania, 300002
Slovakia
KM Management s.r.o., Nitra, SK /ID# 138151
Nitra, Slovakia, 949 01
Gastro I.S.R.O. /ID# 138150
Presov, Slovakia, 080 01
Spain
Hospital Clinic de Barcelona /ID# 144268
Barcelona, Spain, 08036
Complex Hospital University of Ferrol (CHUF) /ID# 133312
Ferrol, Spain, 15405
Hospital Universitario de Gran Canarias Dr. Negrin /ID# 138437
Las Palmas, Spain, 35010
Hospital Universitario La Paz /ID# 133313
Madrid, Spain, 28046
United Kingdom
Western General Hospital /ID# 133317
Edinburgh, United Kingdom, EH4 2XU
Manchester Royal Infirmary /ID# 133316
Manchester, United Kingdom, M13 9WL
John Radcliffe Hospital /ID# 138172
Oxford, United Kingdom, OX3 9DU
Southampton General Hospital NHS Foundation Trust /ID# 133315
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: Ana Lacerda, MD AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02365649     History of Changes
Other Study ID Numbers: M13-740
2014-003240-12 ( EudraCT Number )
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by AbbVie:
Crohn's Disease

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Upadacitinib
Immunologic Factors
Adjuvants, Immunologic
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Physiological Effects of Drugs