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A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03104413
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: placebo for risankizumab IV Drug: risankizumab SC Drug: risankizumab IV Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 579 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : June 22, 2020
Estimated Study Completion Date : June 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Risankizumab Dose 2 (Induction Period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Name: ABBV-066 BI 655066

Experimental: Risankizumab dose 3 (Induction period 2)
Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
Drug: risankizumab SC
risankizumab administered by subcutaneous (SC) injection
Other Name: ABBV-066 BI 655066

Experimental: Risankizumab Dose 2 (Induction Period 1)
Subjects randomized to receive risankizumab dose 2 in Induction Period 1
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Name: ABBV-066 BI 655066

Experimental: Risankizumab Dose 1 (Induction Period 2)
Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Name: ABBV-066 BI 655066

Experimental: Risankizumab Dose 1 (Induction Period 1)
Subjects randomized to receive risankizumab dose 1 in Induction Period 1.
Drug: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Other Name: ABBV-066 BI 655066

Placebo Comparator: Placebo (Induction Period 1)
Subjects randomized to receive placebo for risankizumab in Induction Period 1.
Drug: placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.




Primary Outcome Measures :
  1. Percentage of participants with endoscopic response at Week 12 [ Time Frame: Week 12 ]
    Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).

  2. Percentage of participants with clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per average daily SF and average daily AP score.


Secondary Outcome Measures :
  1. Percentage of participants with enhanced clinical response and endoscopic response at Week 12 [ Time Frame: Week 12 ]
    Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score. Endoscopic response defined as decrease from Baseline in SES-CD.

  2. Percentage of participants with clinical remission per average daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 4 [ Time Frame: Week 4 ]
    Clinical remission per average daily SF and average daily AP score.

  3. Percentage of participants with resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, in participants with EIMs at Baseline [ Time Frame: Week 12 ]
    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.

  4. Percentage of participants with endoscopic healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing was assessed using SES-CD.

  5. Percentage of participants with hospitalization through Week 12 [ Time Frame: Week 12 ]
    Participants with an event that results in admission to the hospital.

  6. Percentage of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 [ Time Frame: Week 12 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.

  7. Percentage of participants with endoscopic remission at Week 12 [ Time Frame: Week 12 ]
    Endoscopic remission is defined as decrease in SES-CD as compared to baseline

  8. Percentage of participants with enhanced clinical response at Week 4 [ Time Frame: Week 4 ]
    Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.

  9. Percentage of participants with enhanced clinical response at Week 12 [ Time Frame: Week 12 ]
    Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.

  10. Percentage of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline [ Time Frame: Week 12 ]
    Participants with draining fistulas at Week 12 in subjects who had draining fistulas at baseline.

  11. Crohn's Symptom Severity (CSS): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The CSS is a patient questionnaire to assess severity of Crohn's symptoms.

  12. Percentage of participants achieving response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom domain [ Time Frame: Week 12 ]
    Response in IBDQ Bowel Symptom domain is defined as increase of IBDQ bowel symptom domain score >= 8 from Baseline

  13. Percentage of participants achieving response in IBDQ fatigue item [ Time Frame: Week 12 ]
    Response in IBDQ fatigue item is defined as increase of IBDQ fatigue item score >=1 from Baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit
  • Diagnosis of CD for at least 3 months prior to Baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Demonstrated intolerance or inadequate response to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

Exclusion Criteria:

  • Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
  • Subjects with unstable doses of concomitant Crohn's disease therapy
  • Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
  • Prior exposure to p19 inhibitors (e.g., risankizumab).
  • Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
  • Having an ostomy or ileoanal pouch

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): NCT03104413


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
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United States, Arizona
Phoenix VA Healthcare /ID# 162261 Not yet recruiting
Phoenix, Arizona, United States, 85012
HonorHealth Research Institute - Shea /ID# 165825 Recruiting
Scottsdale, Arizona, United States, 85258
Physician's Research Group /ID# 211882 Recruiting
Tempe, Arizona, United States, 85284-2604
University of Arizona /ID# 158305 Recruiting
Tucson, Arizona, United States, 85724
United States, Arkansas
Atria Clinical Research /ID# 164504 Recruiting
Little Rock, Arkansas, United States, 72209-7040
United States, California
TLC Clinical Research Inc /ID# 212501 Recruiting
Beverly Hills, California, United States, 90211-2091
Newport Huntington Medical Group /ID# 213034 Not yet recruiting
Huntington Beach, California, United States, 92648
UC San Diego Health Systems /ID# 155576 Recruiting
La Jolla, California, United States, 92093
United Gastroenterologists /ID# 207887 Recruiting
Los Alamitos, California, United States, 90720-3309
Gastrointestinal Biosciences /ID# 162655 Recruiting
Los Angeles, California, United States, 90067-2001
United Gastroenterologists - Murrieta /ID# 158278 Recruiting
Murrieta, California, United States, 92563
United States, Colorado
Peak Gastroenterology Associat /ID# 165832 Recruiting
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Pediatric Gastroenterology /ID# 207171 Recruiting
Lone Tree, Colorado, United States, 80124-6798
United States, Connecticut
Western Connecticut Medical Group /ID# 165874 Recruiting
Danbury, Connecticut, United States, 06810-6000
United States, Florida
Seffner Premier Health Care, P /ID# 162259 Recruiting
Brandon, Florida, United States, 33510
Clinical Res of West FL, Inc. /ID# 205864 Recruiting
Clearwater, Florida, United States, 33765
Clinical Res of West FL, Inc. /ID# 208127 Recruiting
Clearwater, Florida, United States, 33765
South Lake Pain Institute, Inc /ID# 162798 Completed
Clermont, Florida, United States, 34711
Omega Research Consultants, LLC /ID# 171080 Recruiting
DeBary, Florida, United States, 32713-2260
Universal Axon Clinical Resear /ID# 165426 Not yet recruiting
Doral, Florida, United States, 33166
SIH Research, LLC /ID# 163081 Recruiting
Kissimmee, Florida, United States, 34759
Alliance Medical Research /ID# 163834 Recruiting
Lighthouse Point, Florida, United States, 33064
Ctr for Advanced Gastroenterol /ID# 202482 Recruiting
Maitland, Florida, United States, 32751-6108
University of Miami /ID# 155011 Recruiting
Miami, Florida, United States, 33136
ITB Research /ID# 161278 Completed
Miami, Florida, United States, 33176
Vista Health Research LLC - Miami /ID# 212828 Not yet recruiting
Miami, Florida, United States, 33176
Coral Research Clinic /ID# 158330 Recruiting
Miami, Florida, United States, 33186-4643
Nirvana Research Center /ID# 161825 Recruiting
Miami, Florida, United States, 33193
Gastroenterology Group Naples /ID# 165192 Recruiting
Naples, Florida, United States, 34102
Advanced Research Institute /ID# 161973 Recruiting
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 205903 Recruiting
Orlando, Florida, United States, 32803
IMIC Inc. /ID# 154944 Recruiting
Palmetto Bay, Florida, United States, 33157
Clinical Research Trials of Florida, Inc. /ID# 201606 Recruiting
Tampa, Florida, United States, 33607
United States, Georgia
Atlanta Gastro Assoc /ID# 154755 Recruiting
Atlanta, Georgia, United States, 30342
Gastro Assoc of Central GA /ID# 154865 Recruiting
Macon, Georgia, United States, 31201
United States, Illinois
Northwestern University /ID# 158250 Not yet recruiting
Chicago, Illinois, United States, 60611-2927
University of Chicago /ID# 157113 Recruiting
Chicago, Illinois, United States, 60637-1443
NorthShore University HealthSystem - Evanston /ID# 158254 Recruiting
Evanston, Illinois, United States, 60201
Southwest Gastroenterology /ID# 164764 Recruiting
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Cotton-O'Neil Clinical Res Ctr /ID# 154753 Recruiting
Topeka, Kansas, United States, 66606
United States, Kentucky
University of Kentucky Chandler Medical Center /ID# 157109 Recruiting
Lexington, Kentucky, United States, 40536
University of Louisville /ID# 210523 Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Gastroenterology Assoc. LA /ID# 161970 Recruiting
Baton Rouge, Louisiana, United States, 70809
Houma Digestive Health Special /ID# 158253 Recruiting
Houma, Louisiana, United States, 70360
Delricht Research /ID# 206567 Recruiting
New Orleans, Louisiana, United States, 70115
Nola Research Works, LLC /ID# 161271 Recruiting
New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 162239 Recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Maryland
MGG Group, Inc.Chevy Chase Clinical Research /ID# 154846 Recruiting
Chevy Chase, Maryland, United States, 20815
Gastro Center of Maryland /ID# 164766 Recruiting
Columbia, Maryland, United States, 21045
United States, Michigan
Center for Digestive Health /ID# 154697 Recruiting
Troy, Michigan, United States, 48098-6363
United States, Minnesota
Mayo Clinic - Rochester /ID# 163084 Recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Nebraska
University of Nebraska Med Ctr /ID# 210056 Not yet recruiting
Omaha, Nebraska, United States, 68198-2000
United States, Nevada
Comprehensive Digestive Instit /ID# 160167 Recruiting
Las Vegas, Nevada, United States, 89113
Revival Research Institute, LLC /ID# 210986 Recruiting
Las Vegas, Nevada, United States, 89128-3157
United States, New York
NY Scientific /ID# 158272 Recruiting
Brooklyn, New York, United States, 11235
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446 Not yet recruiting
Burnt Hills, New York, United States, 12027
Long Island Clinical Research /ID# 154843 Recruiting
Great Neck, New York, United States, 11021-5343
Digestive Dis Care/Excel Med /ID# 211776 Recruiting
New Hyde Park, New York, United States, 11040
NYU Langone Medical Center /ID# 160166 Recruiting
New York, New York, United States, 10016-6402
Weill Cornell Medicine /ID# 165856 Recruiting
New York, New York, United States, 10022
Icahn School of Med Mt. Sinai /ID# 165610 Recruiting
New York, New York, United States, 10029
Columbia Univ Med Ctr /ID# 167545 Recruiting
New York, New York, United States, 10032
Lenox Hill Hospital, Northwell /ID# 168466 Recruiting
New York, New York, United States, 10075
DiGiovanna Institute for Medic /ID# 171130 Recruiting
North Massapequa, New York, United States, 11758
United States, North Carolina
Carolinas Medical Center /ID# 158364 Recruiting
Charlotte, North Carolina, United States, 28203
Vidant Medical Group, d/b/a Vidant Multi-Specialty Clinic-Kinston /ID# 161109 Completed
Kinston, North Carolina, United States, 28501-1589
Wake Research Associates, LLC /ID# 154891 Recruiting
Raleigh, North Carolina, United States, 27612
United States, North Dakota
Plains Clinical Research Center, LLC /ID# 169712 Recruiting
Fargo, North Dakota, United States, 58104-5925
United States, Ohio
Tri-State Endoscopy /ID# 154939 Completed
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Main Campus /ID# 209225 Not yet recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University - Columbus /ID# 164706 Recruiting
Columbus, Ohio, United States, 43210
Optimed Research, Ltd. /ID# 167877 Recruiting
Columbus, Ohio, United States, 43235
Hometown Urgent Care and Resea /ID# 170447 Recruiting
Dayton, Ohio, United States, 45424
Great Lakes Gastroenterology Research LLC /ID# 201774 Recruiting
Mentor, Ohio, United States, 44060-6211
United States, Oklahoma
Hightower Clinical /ID# 211992 Recruiting
Oklahoma City, Oklahoma, United States, 73102
Digestive Disease Specialists - South /ID# 213224 Not yet recruiting
Oklahoma City, Oklahoma, United States, 73109-3410
Digestive Disease Specialists /ID# 170772 Recruiting
Oklahoma City, Oklahoma, United States, 73112
Adult Gastroenterology Associates - Main /ID# 208857 Recruiting
Tulsa, Oklahoma, United States, 74136-7823
United States, Oregon
Northwest Gastroenterology Cli /ID# 158255 Completed
Portland, Oregon, United States, 97210
United States, Pennsylvania
PennState Milton S.Hershey Med /ID# 154894 Recruiting
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Pittsburgh of UPMC /ID# 212543 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224-1334
Digestive Disease Associates, LTD /ID# 208296 Recruiting
Wyomissing, Pennsylvania, United States, 19610-2002
United States, South Carolina
Medical University of South Carolina /ID# 212859 Not yet recruiting
Charleston, South Carolina, United States, 29425
Gastroenterology Associates, P.A. /ID# 154919 Recruiting
Greenville, South Carolina, United States, 29615-3593
United States, South Dakota
Rapid City Medical Center /ID# 163835 Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Gastro One /ID# 154757 Recruiting
Germantown, Tennessee, United States, 38138
East Tennessee Research Instit /ID# 168735 Recruiting
Johnson City, Tennessee, United States, 37604
Clinical Neuroscience /ID# 164179 Recruiting
Memphis, Tennessee, United States, 38119
Vanderbilt Univ Med Ctr /ID# 157110 Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
TX Clinical Research Institute /ID# 159396 Recruiting
Arlington, Texas, United States, 76012
Inquest Clinical Research /ID# 165696 Recruiting
Baytown, Texas, United States, 77521-2415
Texas Digestive Disease Consultants /ID# 209781 Recruiting
Cedar Park, Texas, United States, 78613-5028
Texas Digestive Disease Consultants /ID# 209945 Recruiting
Cedar Park, Texas, United States, 78613-5028
DHAT Research Institute /ID# 158199 Recruiting
Garland, Texas, United States, 75044-2208
Vilo Research Group Inc /ID# 207654 Recruiting
Houston, Texas, United States, 77017-2337
CliniCore International, LLC /ID# 158191 Recruiting
Houston, Texas, United States, 77027-6812
Baylor College of Medicine /ID# 158194 Recruiting
Houston, Texas, United States, 77030-3411
Precision Research Institute - Houston /ID# 201072 Recruiting
Houston, Texas, United States, 77036
Centex Studies, Inc. - Houston /ID# 201218 Recruiting
Houston, Texas, United States, 77058
Clinical Associates in Researc /ID# 161307 Recruiting
San Antonio, Texas, United States, 78212
Sagact Pllc /Id# 168772 Recruiting
San Antonio, Texas, United States, 78229
Univ Texas HSC San Antonio /ID# 213655 Not yet recruiting
San Antonio, Texas, United States, 78229
Baylor Scott & White Health /ID# 204129 Recruiting
Temple, Texas, United States, 76508
Tyler Research Institute, LLC /ID# 166795 Recruiting
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 164284 Recruiting
Victoria, Texas, United States, 77904
United States, Utah
HP Clinical Research /ID# 162992 Recruiting
Bountiful, Utah, United States, 84010
Advanced Research Institute /ID# 154922 Recruiting
Ogden, Utah, United States, 84403
Advanced Clinical Research (ACR) - Salt Lake City /ID# 161775 Recruiting
West Jordan, Utah, United States, 84088
United States, Virginia
Hunter Holmes McGuire VA Medical Center /ID# 159977 Recruiting
Richmond, Virginia, United States, 23249
United States, Washington
Washington Gastroenterology /ID# 162101 Completed
Bellevue, Washington, United States, 98004
Virginia Mason Medical Center /ID# 155577 Recruiting
Seattle, Washington, United States, 98101
University of Washington /ID# 155584 Not yet recruiting
Seattle, Washington, United States, 98109
United States, West Virginia
West Virginia University /ID# 167942 Recruiting
Morgantown, West Virginia, United States, 26506
American Samoa
Southern California Res. Ctr. /ID# 211989 Recruiting
Coronado, American Samoa, 92118-1408
Argentina
Hopital Centenario /ID# 170904 Recruiting
Rosario, Santa Fe, Argentina, 2000
Cemic /Id# 168082 Recruiting
Buenos Aires, Argentina, 1431
Hospital Britanico de Buenos /ID# 168081 Recruiting
Ciudad Autonomade Buenos Aires, Argentina, C1280AEB
Hospital Privado Univesitario /ID# 168080 Recruiting
Cordoba, Argentina, 5016
Australia, Queensland
Mater Hospital /ID# 167216 Recruiting
Brisbane, Queensland, Australia, 4101
Griffith University /ID# 212631 Not yet recruiting
Southport, Queensland, Australia, 4222
Australia, South Australia
Lyell McEwin Hospital /ID# 211364 Not yet recruiting
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Emeritus Research /ID# 213510 Not yet recruiting
Camberwell, Victoria, Australia, 3124
Footscray Hospital /ID# 211362 Not yet recruiting
Footscray, Victoria, Australia, 3011
Austria
Universitätsklinikum St.Pölten /ID# 166423 Recruiting
St. Pölten, Niederoesterreich, Austria, 3100
LKH-Univ. Klinikum Graz /ID# 158134 Recruiting
Graz, Steiermark, Austria, 8036
Krankenhaus der Barmherzigen Brüder Wien /ID# 211418 Not yet recruiting
Vienna, Wien, Austria, 1020
Medical University of Vienna /ID# 158135 Recruiting
Vienna, Wien, Austria, 1090
Belarus
Vitebsk Regional Advanced Clin /ID# 204807 Recruiting
Vitebsk, Belarus, 210001
Belgium
AZ Sint-Maarten /ID# 212280 Not yet recruiting
Mechelen, Antwerpen, Belgium, 2800
Cliniques Universitaires Saint Luc /ID# 157384 Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
UZ Gent /ID# 157383 Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Imelda Ziekenhuis /ID# 157381 Recruiting
Bonheiden, Belgium, 2820
ULB Erasme /ID# 157386 Recruiting
Brussels, Belgium, 1070
AZ Maria Middelares /ID# 212871 Not yet recruiting
Ghent, Belgium, 9000
AZ Groeninge /ID# 212571 Not yet recruiting
Kortrijk, Belgium, 8500
ZNA - Jan Palfijn /ID# 212822 Not yet recruiting
Merksem, Belgium, 2170
Bosnia and Herzegovina
University Clinical Centre of the Republic of Srpska /ID# 157710 Not yet recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
University Clinical Centre of the Republic of Srpska /ID# 165018 Recruiting
Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
Clinical Center University of Sarajevo /ID# 165132 Recruiting
Sarajevo, Bosnia and Herzegovina, 71000
Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 203975 Recruiting
Pleven, Bulgaria, 5800
University Multiprofile Hospit /ID# 165697 Recruiting
Plovdiv, Bulgaria, 4001
Second Multiprofile Hospital f /ID# 165699 Recruiting
Sofia, Bulgaria, 1202
Acibadem City Clinic Tokuda /ID# 165698 Recruiting
Sofia, Bulgaria, 1407
UMHAT Tsaritsa Joanna - ISUL /ID# 211241 Not yet recruiting
Sofia, Bulgaria, 1527
UMHAT Sv. Ivan Rilski /ID# 204713 Recruiting
Sofia, Bulgaria, 1612
MHAT Trakia /ID# 201665 Recruiting
Stara Zagora, Bulgaria, 6004
University Multiprofile Hospit /ID# 167576 Not yet recruiting
Varna, Bulgaria, 9010
Canada, Alberta
University of Calgary /ID# 157156 Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Allen Whey Khye Lim Professional Corporation /ID# 169766 Recruiting
Edmonton, Alberta, Canada, T5R 1W2
Zeidler Ledcor Centre /ID# 157100 Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Covenant Health /ID# 161636 Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Fraser Clinical Trials Inc /ID# 159057 Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
GIRI Gastrointestinal Research Institute /ID# 157097 Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Percuro Clinical Research, Ltd /ID# 161635 Recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, Nova Scotia
QEII - Victoria Building /ID# 157089 Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
IWK Health Center /ID# 165909 Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
London Health Sciences Centre /ID# 157162 Recruiting
London, Ontario, Canada, N6A 5A5
Scott Shulman Medicine Professional Corporation /ID# 165910 Recruiting
North Bay, Ontario, Canada, P1B 2H3
Medicor Research Inc. /ID# 157151 Completed
Sudbury, Ontario, Canada, P3A 1W8
Toronto Digestive Disease Asso /ID# 157159 Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
CISSS de la Monteregie /ID# 161634 Recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Hospital Maisonneuve-Rosemont /ID# 159058 Recruiting
Montreal, Quebec, Canada, H1T 2M4
Centre Recherche luniver Montr /ID# 167070 Recruiting
Montreal, Quebec, Canada, H2X 0A9
McGill Univ HC /ID# 157086 Recruiting
Montreal, Quebec, Canada, H3G 1A4
Chile
Complejo Asistencial Dr. Sotero del Rio /ID# 169383 Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 8207257
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121 Not yet recruiting
Santiago, Region Metropolitana De Santiago, Chile, 8350488
Centro de Investigaciones Clínicas Viña del Mar /ID# 203585 Completed
Viña del Mar, Valparaíso, Chile, 2540488
Hospital Guillermo Grant Benavente de Concepción /ID# 210758 Not yet recruiting
Concepción, Chile, 4070038
Hospital Las Higueras /ID# 167091 Recruiting
Talcahuano, Chile
Hospital Dr. Hernán Henríquez Aravena /ID# 210729 Not yet recruiting
Temuco, Chile, 4781151
China, Anhui
Renji Hosp, Shanghai Jiaotong /ID# 210706 Not yet recruiting
Shanghai, Anhui, China, 200127
China, Chongqing
Xinqiao Hospital of 3rd Military Medical University /ID# 212954 Not yet recruiting
Chongqing, Chongqing, China, 400037
China, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-Sen University /ID# 211744 Not yet recruiting
Guangzhou, Guangdong, China, 510120
The Sixth Affiliated Hosp, Sun /ID# 210783 Not yet recruiting
Guangzhou, Guangdong, China, 510655
The University of Hong Kong- Shenzhen Hospital /ID# 213108 Not yet recruiting
Shenzhen, Guangdong, China, 518053
China, Hebei
The Second Hospital of Hebei Medical University /ID# 212739 Not yet recruiting
Shijiazhuang, Hebei, China, 050005
China, Jiangxi
1st Aff Hosp Nanchang Univ /ID# 211035 Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 210842 Not yet recruiting
Shanghai, Shanghai, China, 200025
China, Zhejiang
Sir Run Run Shaw Hospital /ID# 210626 Not yet recruiting
Hangzhou, Zhejiang, China, 310016
China
Peking Union Medical College H /ID# 213319 Not yet recruiting
Beijing, China, 100730
The Second Xiangya Hospital of Central South University /ID# 211698 Not yet recruiting
Changsha, China, 410000
West China Hospital, Sichuan University /ID# 210888 Not yet recruiting
Chengdu, China, 610041
Guangdong Provincial People's Hospital /ID# 212950 Not yet recruiting
Guangzhou, China, 510080
Jiangsu Province Hospital /ID# 210500 Not yet recruiting
Nanjing, China, 210029
Shanghai Dongfang Hospital /ID# 212671 Not yet recruiting
Shanghai, China, 200120
Tianjin Med Univ General Hosp /ID# 210925 Not yet recruiting
Tianjin, China, 300052
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211040 Not yet recruiting
Wuhan, China, 430022
Tongji Hosp Tongji Med College /ID# 210857 Not yet recruiting
Wuhan, China, 430030
Colombia
Hospital Univ San Ignacio /ID# 158737 Recruiting
Bogota, Colombia, 110231
Fundacion Cardioinfantil /ID# 167549 Not yet recruiting
Bogota, Colombia
Instituto de Coloproctologia /ID# 158740 Not yet recruiting
Medellin, Colombia, 050024
Hospital Pablo Tobon Uribe /ID# 158732 Recruiting
Medellín, Colombia
Croatia
Klinicka bolnica Dubrava Zagreb /ID# 157719 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Sestre milosrdnice /ID# 157720 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 157703 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Osijek /ID# 157704 Recruiting
Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
Klinicki bolnicki centar Split /ID# 157705 Recruiting
Split, Croatia, 21000
Zadar General Hospital /ID# 157706 Recruiting
Zadar, Croatia, 23000
Czechia
CTCenter MaVe, s.r.o. /ID# 163215 Recruiting
Olomouc, Olomoucky Kraj, Czechia, 779 00
Ikem /Id# 165479 Recruiting
Prague 4, Praha 4, Czechia, 140 00
Thomayerova nemocnice /ID# 162942 Recruiting
Prague, Praha 4, Czechia, 140 59
Axon Clinical, s.r.o. /ID# 163216 Recruiting
Praha, Praha 5, Czechia, 150 00
Nemocnice Horovice, NH Hospita /ID# 211073 Recruiting
Horovice, Czechia, 268 31
Hepato-Gastroenterologie HK s.r.o. /ID# 163218 Recruiting
Hradec Kralove, Czechia, 500 12
Nemocnice Pardubickeho kraje, /ID# 163219 Recruiting
Pardubice, Czechia, 53203
Nemocnice Milosrdnych sester /ID# 211304 Recruiting
Prague 1, Czechia, 118 33
Restrial /ID# 211074 Recruiting
Prague 412, Czechia, 143 00
Denmark
Aarhus University Hospital /ID# 155534 Recruiting
Aarhus N, Midtjylland, Denmark, 8200
Sjaellands Universitets Hospit /ID# 155537 Recruiting
Roskilde, Sjælland, Denmark, 4000
Svendborg Sygehus, Sygehusenhe /ID# 161591 Recruiting
Nyborg, Syddanmark, Denmark, 5800
Aalborg Universitets Hospital /ID# 160685 Completed
Aalborg, Denmark, 9000
Hvidovre Hospital /ID# 155535 Recruiting
Hvidovre, Denmark, 2650
Odense Universitets Hospital /ID# 155536 Recruiting
Odense C, Denmark, 5000
Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876 Recruiting
Alexandria, Egypt, 21131
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423 Recruiting
Alexandria, Egypt, 21131
Internal Medicine Department, Cairo University /ID# 157176 Recruiting
Cairo, Egypt, 11559
Nat Hep & Trop Med Res Inst /ID# 157875 Recruiting
Cairo, Egypt, 11559
Internal Med Dept Ainshams uni /ID# 158630 Recruiting
Cairo, Egypt, 11566
Zagazig University Hospital /ID# 164018 Recruiting
EL Sharkya, Egypt
Estonia
East Tallinn Central Hospital /ID# 157072 Recruiting
Tallinn, Estonia, 10138
West Tallinn Central Hospital /ID# 157073 Recruiting
Tallinn, Estonia, 10617
France
Hopital Beaujon /ID# 166287 Not yet recruiting
Clichy, Ile-de-France, France, 92110
CHU NANCY - Hôpital Brabois Adultes /ID# 162549 Recruiting
Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
CHU Amiens Picardie /ID# 165056 Recruiting
Amiens CEDEX 1, Somme, France, 80054
CHU Grenoble Alpes - Hopital /ID# 211980 Not yet recruiting
Grenoble, France, 38043
Chu Lille /Id# 162547 Not yet recruiting
Lille, France, 59037
CHU de Nice /ID# 162545 Not yet recruiting
Nice, France, 06202
CHU Bordeaux /ID# 162546 Not yet recruiting
Pessac, France, 33600
Chu Lyon Sud /Id# 162548 Not yet recruiting
Pierre Benite, France, 69495
Hospital Pontchaillou /ID# 213207 Not yet recruiting
Rennes, France, 35033
Hopital Nord /ID# 162550 Not yet recruiting
Saint Priest En Jarez, France, 42270
Germany
Universitatsklinikum Mannheim /ID# 162026 Recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Universitaetsklinikum Erlangen /ID# 159332 Recruiting
Erlangen, Bayern, Germany, 91054
Universitatsklinikum Munster /ID# 159333 Recruiting
Munster, Niedersachsen, Germany, 48149
Evangelisches Krankenhaus Kalk /ID# 212724 Not yet recruiting
Cologne, Nordrhein-Westfalen, Germany, 51103
Uniklinik Koln /ID# 164987 Not yet recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527 Recruiting
Saarbrücken, Saarland, Germany, 66111
Univ Hosp Schleswig-Holstein /ID# 159338 Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Universitaetsklinikum Ulm /ID# 164988 Recruiting
Ulm, Thueringen, Germany, 89081
Charité Universitätsmedizin Campus Mitte /ID# 212218 Not yet recruiting
Berlin, Germany, 10117
Charité Universitätsmedizin Campus Mitte /ID# 212892 Not yet recruiting
Berlin, Germany, 10117
Gastroenterologie am Bayerisch /ID# 159339 Recruiting
Berlin, Germany, 10825
DRK Kliniken Berlin /ID# 166149 Recruiting
Berlin, Germany, 14050
Krankenhaus Waldfriede /ID# 212729 Not yet recruiting
Berlin, Germany, 14163
Stadtisches Klinikum Braunschw /ID# 163673 Recruiting
Braunschweig, Germany, 38126
Medizinisches Versorgungszent /ID# 211550 Not yet recruiting
Dachau, Germany, 85221
Agaplesion Markus Krankenhaus /ID# 159334 Recruiting
Frankfurt, Germany, 60341
Universitätsklinikum Freiburg /ID# 162025 Recruiting
Freiburg, Germany, 79106
Praxis Dres. Hülsdonk/Naumann /ID# 211965 Not yet recruiting
Grevenbroich, Germany, 41515
Asklepios Westklinikum Hamburg /ID# 159336 Recruiting
Hamburg, Germany, 22559
Med Hochschule Hanover /ID# 162027 Recruiting
Hannover, Germany, 30625
Praxis fuer Gastroenterologie /ID# 166148 Recruiting
Heidelberg, Germany, 69121
Klinikum Landshut /ID# 211549 Not yet recruiting
Landshut, Germany, 84034
EUGASTRO GmbH /ID# 212077 Not yet recruiting
Leipzig, Germany, 04103
Stadtisches Klin Luneburg GmbH /ID# 163671 Recruiting
Lueneburg, Germany, 21339
Universitatsklinikum Magdeburg /ID# 211840 Not yet recruiting
Magdeburg, Germany, 39120
Gastro Gemeinschaftspraxis /ID# 162024 Recruiting
Minden, Germany, 32423
Klinikum Univ Regensburg /ID# 163812 Recruiting
Regensburg, Germany, 93042
Universitatsklinikum Tubingen /ID# 159341 Recruiting
Tuebingen, Germany, 72076
Gastro-Praxis Wiesbaden /ID# 159335 Completed
Wiesbaden, Germany, 65189
Greece
Tzaneio general hospital of Piraeus /ID# 206441 Recruiting
Piraeus, Attiki, Greece, 18536
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 157418 Recruiting
Athens, Greece, 10676
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170905 Recruiting
Athens, Greece, 11527
University General Hospital of Heraklion "PA.G.N.I" /ID# 157417 Recruiting
Heraklion, Greece, 71110
University General Hospital of Ioannina /ID# 157415 Recruiting
Ioannina, Greece, 45500
General Hospital Nikaias-Piraeus St. Panteleimon /ID# 157419 Recruiting
Pireaus, Greece, 18454
Theageneio Anticancer Hospital /ID# 163922 Recruiting
Thessaloniki, Greece, 54639
Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 213192 Not yet recruiting
Budapest, Hungary, 1036
Semmelweis Egyetem I. Belgyogyaszati Klinika /ID# 213132 Not yet recruiting
Budapest, Hungary, 1083
Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 166814 Not yet recruiting
Debrecen, Hungary, 4031
Debrecen University /ID# 157318 Not yet recruiting
Debrecen, Hungary, 4032
Ireland
St Vincent's University Hospit /ID# 157569 Recruiting
Dublin, Ireland, 4
Beaumont Hospital /ID# 157572 Recruiting
Dublin, Ireland, D09 XR63
University Hospital Galway /ID# 157570 Recruiting
Galway, Ireland, H91 YR71
Israel
Soroka Medical Center /ID# 157789 Recruiting
Be'er Sheva, HaDarom, Israel, 84101
Tel Aviv Sourasky Medical Ctr /ID# 157787 Recruiting
Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
Hadassah Ein Kerem Medical Ctr /ID# 171062 Recruiting
Jerusalem, Yerushalayim, Israel, 91120
Rambam Medical Center /ID# 171056 Recruiting
Haifa, Israel, 3525408
Shaare Zedek Medical Center /ID# 163539 Recruiting
Jerusalem, Israel, 91031
Shaare Zedek Medical Center /ID# 171055 Recruiting
Jerusalem, Israel, 91031
Sheba Medical Center /ID# 171059 Recruiting
Ramat Gan, Israel, 5262100
Italy
Universita di Catanzaro Magna Graecia /ID# 212017 Not yet recruiting
Catanzaro, Calabria, Italy, 88100
AOU Policlinico S.Orsola Malpighi /ID# 155659 Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018 Not yet recruiting
Modena, Emilia-Romagna, Italy, 41124
Policlinico Universitario Campus Bio-Medico /ID# 162433 Recruiting
Rome, Lazio, Italy, 00128
A.O. San Camillo-Forlanini /ID# 155660 Recruiting
Rome, Lazio, Italy, 00152
Azienda Policlinico Universitario Umberto I /ID# 166910 Recruiting
Rome, Lazio, Italy, 00161
Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434 Recruiting
Genoa, Liguria, Italy, 16132
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 155657 Recruiting
Milan, Lombardia, Italy, 20122
ASST Rhodense /ID# 211453 Not yet recruiting
Rho, Lombardia, Italy, 20017
Istituto Clinico Humanitas /ID# 155658 Recruiting
Rozzano, Milano, Italy, 20089
Presidio Columbus, Fondazione Policlinico Gemelli Universita Cattolica S. Cuore /ID# 155656 Recruiting
Rome, Roma, Italy, 00168
A.O. Per L'Emergenza Cannizzaro /ID# 161303 Recruiting
Catania, Sicilia, Italy, 95126
Azienda Ospedaliera Univ. Meyer /ID# 168049 Recruiting
Florence, Toscana, Italy, 50139
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 161302 Recruiting
Negrar, Verona, Italy, 37024
Ospedali Riuniti Universita /ID# 162431 Recruiting
Ancona, Italy, 60023
ASST Fatebenefratelli Sacco /ID# 155655 Recruiting
Milan, Lombardia, Italy, 20157
IRCCS Policlinico S. Matteo /ID# 212030 Not yet recruiting
Pavia, Italy, 27100
Policlinico Tor Vergata /ID# 158023 Recruiting
Rome, Italy, 00133
Korea, Republic of
Dong-A University Hospital /ID# 163370 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 163376 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr /ID# 163366 Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
CHA Bundang Medical center, CHA University /ID# 163377 Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
Kangbuk Samsung Hospital /ID# 163354 Recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
Severance Hospital /ID# 163374 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 163426 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Haeundae Paik Hospital /ID# 202516 Recruiting
Busan, Korea, Republic of, 48108
Hanyang University Guri Hosp /ID# 163351 Recruiting
Guri-si, Korea, Republic of, 471-701
The Catholic Univ. of Korea /ID# 163365 Recruiting
Gyeonggi-do, Korea, Republic of, 16247
Latvia
Riga East Clinical Univ Hosp /ID# 159615 Recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 159616 Recruiting
Riga, Latvia, LV-1002
Lithuania
Hospital of lithuanian university of Health Science Kauno Klinikos /ID# 162584 Recruiting
Kaunas, Lithuania, 50161
Vilnius University Hospital /ID# 162524 Recruiting
Vilnius, Lithuania, LT-08661
Malaysia
UKM Medical Centre /ID# 201362 Recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Universiti Sains Malaysia /ID# 160661 Recruiting
Kelantan, Malaysia, 16150
Queen Elizabeth Hospital /ID# 160659 Recruiting
Kota Kinabalu, Malaysia, 88586
Mexico
Investigación Biomédica para el Desarrollo de Fármacos, S.A. de C.V. /ID# 170766 Recruiting
Zapopan, Jalisco, Mexico, 45030
JM Research /ID# 170762 Recruiting
Cuernavaca, Morelos, Mexico, 62290
Unidad de Atencion Medica e Investigacion en Salud /ID# 170765 Recruiting
Merida Yucatan, Mexico, 97000
Health Pharma Professional Res /ID# 170763 Recruiting
Mexico, Mexico, 03810
Netherlands
Academisch Medisch Centrum /ID# 157953 Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Elisabeth Tweesteden Ziekenhuis /ID# 163620 Recruiting
Tilburg, Netherlands, 5022 GC
New Zealand
Christchurch Hospital /ID# 167212 Recruiting
Christchurch, Canterbury, New Zealand, 8011
Middlemore Clinical Trials /ID# 167214 Recruiting
Auckland, New Zealand, 2025
Dunedin Hospital /ID# 167215 Recruiting
Dunedin, New Zealand, 9016
Wellington Hospital (Capital and Coast District Health Board) /ID# 167213 Recruiting
Wellington, New Zealand, 6021
Poland
Planetmed Sp. z o.o. /ID# 205159 Recruiting
Wrocław, Dolnoslaskie, Poland, 52-210
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578 Not yet recruiting
Warsaw, Mazowieckie, Poland, 04-730
Centrum Zdrowia MDM /ID# 163602 Recruiting
Warszawa, Mazowieckie, Poland, 00-635
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604 Recruiting
Warszawa, Mazowieckie, Poland, 02-507
Centrum Medyczne LukaMed /ID# 212079 Not yet recruiting
Chojnice, Poland, 89-600
Uniwersytecki Szpital Kliniczn /ID# 212290 Not yet recruiting
Lodz, Poland, 90-153
1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984 Recruiting
Lublin, Poland, 20-049
SPSK Nr 4 /ID# 209980 Not yet recruiting
Lublin, Poland, 20-954
Wojewódzki Szpital Specjalistyczny w Olsztynie /ID# 212400 Not yet recruiting
Olsztyn, Poland, 10-561
Centrum Medyczne Medyk /ID# 212888 Not yet recruiting
Rzeszow, Poland, 35-055
H-T. Centrum Medyczne Spółka z o.o. Spółka Komandytowa /ID# 212458 Not yet recruiting
Tychy, Poland, 43-110
NZOZ Vivamed /ID# 202434 Recruiting
Warsaw, Poland, 03-580
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 212534 Not yet recruiting
Wrocław, Poland, 50-556
Portugal
Hospital Senhora da Oliveira de Guimarães, EPE /ID# 160691 Recruiting
Guimarães, Braga, Portugal, 4835-044
Centro Hospitalar do Algarve - Hospital de Portimão /ID# 167754 Recruiting
Portimao, Faro, Portugal, 8500-338
Centro Hosp de Lisboa Central /ID# 160677 Recruiting
Lisbon, Lisboa, Portugal, 1169-050
Centro Hospitalar Lisboa Ocidental, EPE /ID# 167753 Recruiting
Lisbon, Lisboa, Portugal, 1349-019
Hospital Garcia de Orta, E.P.E /ID# 160688 Recruiting
Almada, Setubal, Portugal, 2805-267
Centro Hospitalar do Algarve /ID# 160732 Recruiting
Faro, Portugal, 8000-386
Centro Hospitalar Lisboa Norte, EPE /ID# 160741 Recruiting
Lisboa, Portugal, 1649-035
Hospital Beatriz Angelo /ID# 207758 Not yet recruiting
Loures, Portugal, 2674-514
Centro Hospitalar de Sao Joao, EPE /ID# 160742 Recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de Entre o D /ID# 160676 Recruiting
Santa Maria Da Feira, Portugal, 4520-211
Centro Hosp de Tondela-Viseu /ID# 160731 Recruiting
Viseu, Portugal, 3504 - 509
Romania
Clinic Fundeni Institute /ID# 170890 Recruiting
Bucharest, Bucuresti, Romania, 022328
Institutul Clinic Fundeni /ID# 170888 Recruiting
Bucharest, Romania, 22328
Tvm Med Serv Srl /Id# 170891 Recruiting
Cluj, Romania, 400132
Cabinet Particular Policlinic Algomed /ID# 170889 Recruiting
Timisoara, Romania, 300002
Centrul Medical Tuculanu SRL /ID# 170892 Recruiting
Timisoara, Romania, 300168
Russian Federation
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 200707 Recruiting
Kemerovo, Kemerovskaya Oblast, Russian Federation, 650066
Perm state medical university n.a. E.A. Vagner /ID# 207438 Not yet recruiting
Perm, Permskiy Kray, Russian Federation, 614990
Private institution Center of educational and clinical gastroenterology, hepatol /ID# 200701 Completed
Stavropol, Stavropol Skiy Kray, Russian Federation, 355012
Tver Regional Clinical Hosp. /ID# 206586 Recruiting
Tver, Tverskaya Oblast, Russian Federation, 170036
Regional Clinical Hospital #1 /ID# 200708 Recruiting
Tyumen, Tyumenskaya Oblast, Russian Federation, 625023
Alliance Biomedical Ural Group /ID# 200703 Recruiting
Izhevsk, Udmurtskaya Respublika, Russian Federation, 426061
Scien Ctr Coloproctology Rosme /ID# 204806 Recruiting
Moscow, Russian Federation, 123423
State Pediatric Med University /ID# 211975 Not yet recruiting
St. Petersburg, Russian Federation, 194100
City Clinical Hospital # 31 /ID# 208865 Not yet recruiting
St. Petersburg, Russian Federation, 197110
Ulyanovsk State clinical hospi /ID# 200700 Recruiting
Ulyanovsk, Russian Federation, 432063
Serbia
Clinical Center Serbia /ID# 156957 Recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 156956 Recruiting
Belgrade, Beograd, Serbia, 11000
Military Medical Academy /ID# 156963 Not yet recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 156959 Recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center Kragujevac /ID# 156961 Recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Clinical Center Vojvodina /ID# 156958 Recruiting
Novi Sad, Vojvodina, Serbia, 21000
University Children's Hospital 'Tirsova' /ID# 211480 Not yet recruiting
Belgrade, Serbia, 11000
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798 Not yet recruiting
Belgrade, Serbia, 11040
Singapore
National University Hospital /ID# 160662 Not yet recruiting
Singapore, Singapore, 119074
Singapore General Hospital /ID# 160663 Not yet recruiting
Singapore, Singapore, 169608
KL Ling Gastroenterology and Liver Clinic /ID# 205736 Recruiting
Singapore, Singapore, 228510
Slovakia
Univerzitna nemocnica Martin /ID# 163205 Completed
Martin, Zilinsky Kraj, Slovakia, 036 01
FN s poliklinikou F.D. Rooseve /ID# 156453 Recruiting
Banska Bystrica, Slovakia, 97517
KM Management s.r.o. /ID# 206762 Recruiting
Nitra, Slovakia, 949 01
Gastro I.S.R.O. /ID# 156455 Recruiting
Presov, Slovakia, 08001
South Africa
Wits Clinical Research Site /ID# 171169 Recruiting
Parktown, Gauteng, South Africa, 2193
Mediclinic Milnerton /ID# 171172 Recruiting
CAPE TOWN,Milnerton, Western Cape, South Africa, 7441
Kingsbury Hospital /ID# 171158 Recruiting
Cape Town, Western Cape, South Africa, 7708
Mediclinic Constantiaberg /ID# 171159 Recruiting
Cape Town, Western Cape, South Africa, 7800
Spain
Complejo Hospitalario Universitario de Ferrol /ID# 157534 Recruiting
Ferrol, Galicia, Spain, 15405
Hospital Universitario y Politecnico La Fe /ID# 157537 Recruiting
Valencia, Valenciana, Spain, 46026
Hospital Clinico y Provincial Barcelona /ID# 157533 Recruiting
Barcelona, Spain, 08036
Corp Sanit Parc Tauli Sabadell /ID# 159234 Recruiting
Barcelona, Spain, 08208
Hospital Universitario Basurto /ID# 205188 Not yet recruiting
Bilbao, Spain, 48013
Hospital General Universitario Gregorio Maranon /ID# 161144 Recruiting
Madrid, Spain, 28007
Hospital Universitario La Paz /ID# 159232 Recruiting
Madrid, Spain, 28046
Hospital Clinico Univ de Salamanca /ID# 157539 Recruiting
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena /ID# 159966 Recruiting
Sevilla, Spain, 41009
Hosp Clin Univ de Valencia /ID# 209699 Recruiting
Valencia, Spain, 46010
Hospital Univ Miguel Servet /ID# 157538 Recruiting
Zaragoza, Spain, 50009
Switzerland
Universitaetsspital Basel /ID# 166321 Recruiting
Basel, Switzerland, 4031
University Hospital Zurich /ID# 163528 Recruiting
Zurich, Switzerland, 8091
Taiwan
China Medical University Hosp /ID# 160130 Recruiting
Taichung City, Taichung, Taiwan, 40447
National Cheng Kung University Hospital /ID# 160129 Recruiting
Tainan City, Tainan, Taiwan, 70403
Taichung Veterans General Hosp /ID# 160134 Recruiting
Taichung City, Taiwan, 40705
Taipei Veterans General Hosp /ID# 212711 Not yet recruiting
Taipei City, Taiwan, 11217
National Taiwan University Hos /ID# 162189 Recruiting
Taipei, Taiwan, 10041
Ukraine
Kyiv Municipal Clinical Hospital #18 /ID# 162527 Completed
Kiev, Kyiv, Ukraine, 03134
Transcarpathian Regional Clin. /ID# 167958 Recruiting
Uzhhorod, Ukraine, 88000
United Kingdom
Queen Elizabeth University Hos /ID# 202314 Recruiting
Glasgow, Glasgow City, United Kingdom, G51 4TF
Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938 Recruiting
Chertsey, Surrey, United Kingdom, KT16 0PZ
Barnsley Hospital NHS Foundation Trust /ID# 202772 Recruiting
Barnsley, United Kingdom, S75 2EP
Univ Hospitals Birmingham NHS Foundation trust /ID# 157577 Recruiting
Birmingham, United Kingdom, B15 2TG
Fairfield General Hospital /ID# 207765 Not yet recruiting
Bury, United Kingdom, BL9 7TD
Addenbrookes Hospital /ID# 158037 Recruiting
Cambridge, United Kingdom, CB2 0SP
Western General Hospital /ID# 207446 Recruiting
Edinburgh, United Kingdom, EH4 2XU
Hull and East Yorkshire NHS /ID# 158759 Recruiting
Hull, United Kingdom, HU8 9HE
Kings Healthcare NHS Trust /ID# 158758 Recruiting
London, United Kingdom, SE5 9RS
Royal Victoria Infirmary, Newc /ID# 163889 Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
John Radcliffe Hospital /ID# 158039 Recruiting
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03104413     History of Changes
Other Study ID Numbers: M15-991
2016-003190-17 ( EudraCT Number )
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
ABBV-066
BI 655066

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs