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A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

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: NCT03398148
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis (UC) Drug: risankizumab IV Drug: placebo for risankizumab Drug: risankizumab SC Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 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 Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : September 23, 2020
Estimated Study Completion Date : August 29, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 2
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 2, Induction 1: Open-label Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(a)
Participants who received placebo with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 3
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 2
Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(a)
Participants who received placebo with inadequate response in Induction 1 receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 1(b)
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 2, Induction 1: Double-blind Risankizumab Dose 1
Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 1, Induction 1: Double-blind Risankizumab Dose 3
Participants randomized to receive risankizumab dose 3 administered by intravenous (IV) infusion.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Placebo Comparator: Substudy 1, Induction 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Drug: placebo for risankizumab
placebo for risankizumab

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 2
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 1, Induction 2: Double-blind Risankizumab Dose 3
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Induction 2.
Drug: risankizumab SC
risankizumab subcutaneous (SC) injection
Other Names:
  • ABBV-066
  • BI 655066

Placebo Comparator: Substudy 2, Induction 1: Double-blind Placebo
Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Drug: placebo for risankizumab
placebo for risankizumab

Experimental: Substudy 2, Induction 2: Double-blind Risankizumab Dose 1(b)
Participants who received risankizumab with inadequate response in Induction 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Induction 2.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066

Experimental: Substudy 1, Induction 1: Open-label Risankizumab Dose 3
Participants receive risankizumab dose 3 administered by intravenous (IV) infusion.
Drug: risankizumab IV
risankizumab intravenous (IV) infusion
Other Names:
  • ABBV-066
  • BI 655066




Primary Outcome Measures :
  1. Percentage of participants with clinical remission per adapted Mayo Score at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per adapted Mayo Score.


Secondary Outcome Measures :
  1. Percentage of participants achieving clinical remission per full Mayo Score at Week 12 in subjects with a full Mayo score of 6 to 12 at Baseline [ Time Frame: Week 12 ]
    Clinical remission per full Mayo Score.

  2. Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The US-SQ is a patient questionnaire to assess severity of Crohn's symptoms.

  3. Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.

  4. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.

  5. Percentage of participants achieving clinical response per adapted Mayo Score at week 12 [ Time Frame: Week 12 ]
    Clinical response per adapted Mayo Score.

  6. Percentage of participants with endoscopic remission at Week 12 [ Time Frame: Week 12 ]
    Endoscopic remission per endoscopy subscore.

  7. Percentage of participants achieving clinical response per partial adapted Mayo Score at week 4 [ Time Frame: Week 4 ]
    Clinical response per partial adapted Mayo Score (without endoscopy).

  8. Percentage of participants with mucosal healing at Week 12 [ Time Frame: Week 12 ]
    Mucosal healing defined as endoscopic and histologic remission.

  9. 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The SF-36 is an indicator of overall health status.

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

  11. Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 12 [ Time Frame: 12 weeks ]
    Participants who underwent surgery related to UC.

  12. Percentage of participants with endoscopic improvement at Week 12 [ Time Frame: Week 12 ]
    Endoscopic improvement per endoscopy subscore.



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 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
  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
  • Active UC as assessed by adapted Mayo Score
  • Demonstrated intolerance or inadequate response to one or more biologic therapies
  • Females must be postmenopausal for more than 2 years or surgically sterile or practicing specific forms of birth control.

Exclusion Criteria:

  • Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Subject receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Subject with currently known complications of UC (e.g., megacolon).

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): NCT03398148


Contacts
Layout table for location contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

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Locations
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United States, California
Ucsd /Id# 160452 Recruiting
La Jolla, California, United States, 92093
United Gastroenterologists /ID# 158528 Recruiting
Los Alamitos, California, United States, 90720-3309
Gastrointestinal Biosciences /ID# 200931 Recruiting
Los Angeles, California, United States, 90067-2001
UCSF Center for Colitis and Crohn's Disease /ID# 201210 Recruiting
San Francisco, California, United States, 94115-3011
Kaiser Permanente - San Francisco /ID# 211627 Not yet recruiting
San Francisco, California, United States, 94115
Cedars-Sinai Medical Center - West Hollywood /ID# 163851 Recruiting
West Hollywood, California, United States, 90048
United States, Colorado
Peak Gastroenterology Associat /ID# 165841 Recruiting
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Pediatric Gastroenterology /ID# 207174 Recruiting
Lone Tree, Colorado, United States, 80124-6798
United States, Connecticut
Medical Research Ctr CT /ID# 160311 Recruiting
Hamden, Connecticut, United States, 06518
Yale Univ Digestive Diseases /ID# 213179 Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
South Lake Pain Institute, Inc /ID# 162878 Completed
Clermont, Florida, United States, 34711
Ctr for Advanced Gastroenterol /ID# 202811 Recruiting
Maitland, Florida, United States, 32751-6108
Coral Research Clinic /ID# 158584 Recruiting
Miami, Florida, United States, 33186-4643
Nirvana Research Center /ID# 161848 Recruiting
Miami, Florida, United States, 33193
Gastroenterology Group Naples /ID# 165212 Recruiting
Naples, Florida, United States, 34102
Advanced Research Institute /ID# 161938 Recruiting
New Port Richey, Florida, United States, 34653
Endoscopic Research, Inc. /ID# 206711 Recruiting
Orlando, Florida, United States, 32803
Florida Hospital /ID# 160433 Not yet recruiting
Orlando, Florida, United States, 32803
Omega Research Maitland /ID# 203059 Recruiting
Orlando, Florida, United States, 32810
Lenus Research & Medical Group /ID# 169730 Recruiting
Sweetwater, Florida, United States, 33172
Clinical Research Trials of Florida, Inc. /ID# 201783 Recruiting
Tampa, Florida, United States, 33607
Florida Hospital Tampa /ID# 170503 Recruiting
Tampa, Florida, United States, 33613-4680
United States, Georgia
Gastro Assoc of Central GA /ID# 160523 Recruiting
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Spec /ID# 161372 Completed
Suwanee, Georgia, United States, 30024
United States, Illinois
University of Chicago /ID# 160521 Recruiting
Chicago, Illinois, United States, 60637-1443
DM Clinical Research/Southwest /ID# 165012 Recruiting
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Indiana University /ID# 167252 Not yet recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Cotton-O'Neil Clinical Res Ctr /ID# 160412 Completed
Topeka, Kansas, United States, 66606
United States, Louisiana
Houma Digestive Health Special /ID# 158317 Recruiting
Houma, Louisiana, United States, 70360
Delricht Research /ID# 206815 Recruiting
New Orleans, Louisiana, United States, 70115
Nola Research Works, LLC /ID# 161368 Recruiting
New Orleans, Louisiana, United States, 70115
Louisiana Research Ctr. LLC /ID# 201204 Recruiting
Shreveport, Louisiana, United States, 71105-6800
United States, Massachusetts
MGH Digestive Health Center /ID# 164255 Recruiting
Boston, Massachusetts, United States, 02114
Children's Hospital Boston /ID# 171034 Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Hospitals /ID# 158524 Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Center for Digestive Health /ID# 160327 Recruiting
Troy, Michigan, United States, 48098-6363
United States, Minnesota
Mayo Clinic - Rochester /ID# 200458 Recruiting
Rochester, Minnesota, United States, 55905-0001
United States, Nebraska
Quality Clinical Research Inc. /ID# 167313 Recruiting
Omaha, Nebraska, United States, 68114
United States, New York
Concorde Medical Group PLLC /ID# 211805 Not yet recruiting
New York, New York, United States, 10016
Columbia Univ Medical Center /ID# 161934 Recruiting
New York, New York, United States, 10032-3725
Lenox Hill Hospital, Northwell /ID# 168470 Recruiting
New York, New York, United States, 10075
DiGiovanna Institute for Medic /ID# 171129 Recruiting
North Massapequa, New York, United States, 11758
Wilmot Cancer Center /ID# 161664 Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Medical Center /ID# 158512 Recruiting
Charlotte, North Carolina, United States, 28203
Carolina Research, Greenville, NC /ID# 201090 Completed
Greenville, North Carolina, United States, 27834
United States, North Dakota
Plains Clinical Research Center, LLC /ID# 169732 Recruiting
Fargo, North Dakota, United States, 58104-5925
United States, Ohio
Cleveland Clinic Main Campus /ID# 209232 Recruiting
Cleveland, Ohio, United States, 44195
The Ohio State University - Columbus /ID# 164714 Recruiting
Columbus, Ohio, United States, 43210
Optimed Research, Ltd. /ID# 167113 Recruiting
Columbus, Ohio, United States, 43235
Great Lakes Gastroenterology Research LLC /ID# 201777 Recruiting
Mentor, Ohio, United States, 44060-6211
United States, Oklahoma
Digestive Disease Specialists /ID# 170779 Recruiting
Oklahoma City, Oklahoma, United States, 73112
Adult Gastroenterology Associates - Main /ID# 208867 Recruiting
Tulsa, Oklahoma, United States, 74136-7823
United States, Pennsylvania
University of Pennsylvania /ID# 166266 Recruiting
Philadelphia, Pennsylvania, United States, 19104-5502
United States, South Carolina
Gastroenterology Associates, P.A. /ID# 160472 Recruiting
Greenville, South Carolina, United States, 29615-3593
United States, Tennessee
Gastro One /ID# 160418 Recruiting
Germantown, Tennessee, United States, 38138
East Tennessee Research Instit /ID# 168747 Recruiting
Johnson City, Tennessee, United States, 37604
Vanderbilt Univ Med Ctr /ID# 160580 Recruiting
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Inquest Clinical Research /ID# 165685 Recruiting
Baytown, Texas, United States, 77521-2415
Texas Digestive Disease Consultants /ID# 209798 Recruiting
Cedar Park, Texas, United States, 78613-5028
Texas Digestive Disease Consultants /ID# 209950 Recruiting
Cedar Park, Texas, United States, 78613-5028
DHAT Research Institute /ID# 158226 Recruiting
Garland, Texas, United States, 75044-2208
Vilo Research Group Inc /ID# 207656 Recruiting
Houston, Texas, United States, 77017-2337
CliniCore International, LLC /ID# 158218 Recruiting
Houston, Texas, United States, 77027-6812
Baylor College of Medicine /ID# 158221 Not yet recruiting
Houston, Texas, United States, 77030-3411
Precision Research Institute - Houston /ID# 201351 Recruiting
Houston, Texas, United States, 77036
Centex Studies, Inc. - Houston /ID# 201222 Recruiting
Houston, Texas, United States, 77058
Caprock Gastro Research /ID# 215432 Not yet recruiting
Lubbock, Texas, United States, 79424-3017
Clinical Associates in Researc /ID# 161376 Recruiting
San Antonio, Texas, United States, 78212
Sagact Pllc /Id# 168776 Recruiting
San Antonio, Texas, United States, 78229
Baylor Scott & White Health - Temple /ID# 204130 Recruiting
Temple, Texas, United States, 76508
Tyler Research Institute, LLC /ID# 166800 Recruiting
Tyler, Texas, United States, 75701
Victoria gastroenterology /ID# 164321 Recruiting
Victoria, Texas, United States, 77904
United States, Utah
Advanced Research Institute /ID# 160480 Recruiting
Ogden, Utah, United States, 84403
United States, Washington
Virginia Mason Medical Center /ID# 160466 Recruiting
Seattle, Washington, United States, 98101
American Samoa
Southern California Res. Ctr. /ID# 169660 Recruiting
Coronado, American Samoa, 92118-1408
Argentina
Hopital Centenario /ID# 170898 Recruiting
Rosario, Santa Fe, Argentina, 2000
Cemic /Id# 167782 Not yet recruiting
Buenos Aires, Argentina, 1431
Instituto Medico CER /ID# 168686 Not yet recruiting
Quilmes, Argentina, 1878
Sanatorio 9 de Julio S.A. /ID# 167780 Recruiting
San Miguel de Tucuman, Argentina, 4000
Austria
Universitätsklinikum St.Pölten /ID# 169048 Recruiting
St. Pölten, Niederoesterreich, Austria, 3100
Medical University of Vienna /ID# 169050 Recruiting
Vienna, Wien, Austria, 1090
LKH-Univ. Klinikum Graz /ID# 169053 Recruiting
Graz, Austria, 8036
LKH Salzburg and Paracelsus /ID# 200685 Recruiting
Salzburg, Austria, 5020
Belgium
CUB Hospital Erasme /ID# 200252 Recruiting
Brussels, Bruxelles-Capitale, Belgium, 1070
Cliniques Universitaires Saint Luc /ID# 200039 Recruiting
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
CHU de Liege /ID# 200253 Recruiting
Liège, Liege, Belgium, 4000
UZ Gent /ID# 200251 Not yet recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Imelda Ziekenhuis /ID# 211100 Recruiting
Bonheiden, Belgium, 2820
UZ Brussels /ID# 164176 Not yet recruiting
Jette, Brussels, Belgium, 1090
UZ Leuven /ID# 170812 Recruiting
Leuven, Belgium, 3000
Clinique St Joseph /ID# 200250 Recruiting
Liege, Belgium, 4000
AZ-Delta /ID# 200040 Recruiting
Roeselare, Belgium, 8800
CHU Dinant Godinne - UCL Namur /ID# 200254 Recruiting
Yvoir, Belgium, 5530
Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda /ID# 157679 Recruiting
Goiania, Goias, Brazil, 74535-170
Hospital Nossa Senhora das Graças /ID# 157671 Recruiting
Curitiba, Parana, Brazil, 80810-040
Hospital de Clinicas de Porto Alegre /ID# 157662 Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Upeclin Fmb - Unesp /Id# 157690 Recruiting
Botucatu, Sao Paulo, Brazil, 18618-686
Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP /ID# 157660 Recruiting
Ribeirão Preto, Sao Paulo, Brazil, 14048-900
Faculdade de Medicina do ABC /ID# 163995 Recruiting
Santo André, Sao Paulo, Brazil, 09060-870
Kaiser Clinica e Hospital Dia /ID# 157680 Recruiting
Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015-110
Hosp U Clementino Fraga Filho /ID# 157661 Not yet recruiting
Rio de Janeiro, Brazil, 21941-913
Bulgaria
MBAL "Hadzhi Dimitar" /ID# 207945 Not yet recruiting
Sliven, Bulgaria, 8800
II MHAT - Sofia /ID# 200799 Not yet recruiting
Sofia, Bulgaria, 1202
UMHAT Tsaritsa Joanna - ISUL /ID# 209977 Not yet recruiting
Sofia, Bulgaria, 1527
UMHAT Sv. Ivan Rilski /ID# 210797 Not yet recruiting
Sofia, Bulgaria, 1612
Canada, Alberta
University of Calgary /ID# 169111 Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Allen Whey Khye Lim Professional Corporation /ID# 169767 Recruiting
Edmonton, Alberta, Canada, T5R 1W2
Zeidler Ledcor Centre /ID# 204588 Not yet recruiting
Edmonton, Alberta, Canada, T6G 2X8
Covenant Health /ID# 169114 Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Canada, British Columbia
Fraser Clinical Trials Inc /ID# 169102 Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
Percuro Clinical Research, Ltd /ID# 169109 Recruiting
Victoria, British Columbia, Canada, V8V 3M9
Canada, Nova Scotia
IWK Health Center /ID# 169110 Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
London Health Sciences Centre /ID# 169103 Recruiting
London, Ontario, Canada, N6A 5A5
Scott Shulman Medicine Professional Corporation /ID# 169113 Recruiting
North Bay, Ontario, Canada, P1B 2H3
Toronto Digestive Diseases Ass /ID# 169106 Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Canada, Quebec
Hopital Charles-Lemoyne /ID# 169105 Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Hotel-Dieu de Levis /ID# 214378 Not yet recruiting
Levis, Quebec, Canada, G6V 3Z1
CIUSSS de l'Est de l'Ile de Montréal /ID# 169108 Not yet recruiting
Montréal, Quebec, Canada, H1T 2M4
Montreal General Hospital /ID# 169104 Not yet recruiting
Montréal, Quebec, Canada, H3G 1A4
Chile
Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151 Not yet recruiting
Victoria, Araucania, Chile, 4720843
Complejo Asistencial Dr. Sotero del Rio /ID# 169385 Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 8207257
Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125 Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 8350488
Hospital Guillermo Grant Benavente de Concepción /ID# 210761 Not yet recruiting
Concepción, Chile, 4070038
Hospital Las Higueras /ID# 167093 Recruiting
Talcahuano, Chile
Hospital Dr. Hernán Henríquez Aravena /ID# 210731 Not yet recruiting
Temuco, Chile, 4781151
China, Anhui
The First Affiliated Hospital of Anhui Medical University /ID# 211228 Not yet recruiting
Hefei, Anhui, China, 230022
Renji Hosp, Shanghai Jiaotong /ID# 211233 Not yet recruiting
Shanghai, Anhui, China, 200127
China, Guangdong
The Sixty Affiliated Hospital of Sun Yat-Sen University /ID# 211231 Not yet recruiting
Guangzhou, Guangdong, China, 510655
China, Hebei
The Second Hospital of Hebei Medical University /ID# 213018 Not yet recruiting
Shijiazhuang, Hebei, China, 050005
China, Hunan
Xiangya Hospital Central South University /ID# 211197 Not yet recruiting
Changsha, Hunan, China, 410008
China, Jiangxi
1st Aff Hosp Nanchang Univ /ID# 212183 Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
The First Hosp of Jilin Univ /ID# 212278 Not yet recruiting
Changchun, Jilin, China, 130021
China, Ningxia
General Hospital of Ningxia Medical University /ID# 213911 Not yet recruiting
Yinchuan, Ningxia, China, 750004
China, Shaanxi
Xijing Hospital /ID# 211639 Not yet recruiting
Xian, Shaanxi, China, 710032
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong /ID# 210962 Not yet recruiting
Shanghai, Shanghai, China, 200025
China, Sichuan
West China Hospital /ID# 211276 Not yet recruiting
Chengdu, Sichuan, China, 610041
China, Zhejiang
The second affiliated hospital of Zhejiang University school of medicine /ID# 211025 Not yet recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital /ID# 211064 Not yet recruiting
Hangzhou, Zhejiang, China, 310016
China
Beijing Friendship Hospital /ID# 211066 Not yet recruiting
Beijing, China, 100050
The Second Xiangya Hospital of Central South University /ID# 211198 Not yet recruiting
Changsha, China, 410000
Jiangsu Province Hospital /ID# 211232 Not yet recruiting
Nanjing, China, 210029
Shengjing Hospital of China Medical University /ID# 211646 Not yet recruiting
Shenyang, China, 110004
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211071 Not yet recruiting
Wuhan, China, 430022
Tongji Hosp Tongji Med College /ID# 211072 Not yet recruiting
Wuhan, China, 430030
Renmin Hospital of Wuhan Univ /ID# 212868 Not yet recruiting
Wuhan, China, 430060
4th Military Medical Universit /ID# 215504 Not yet recruiting
Xi'an, China, 710038
Colombia
Corporacion Hospitalaria Juan Ciudad sede Denominada Hospital Universitario Mayo /ID# 158717 Not yet recruiting
Bogota DC, Cundinamarca, Colombia, 11411
Instituto de Coloproctologia /ID# 158739 Not yet recruiting
Medellin, Colombia, 050024
Hospital Universitario San Vic /ID# 171490 Recruiting
Medellin, Colombia, 50010
Inst Med Alta Tec Onc (IMAT) /ID# 206937 Recruiting
Montería, Colombia, 230002
Croatia
Klinicka bolnica Dubrava Zagreb /ID# 157475 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 157471 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Zagreb /ID# 201917 Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Klinicki bolnicki centar Osijek /ID# 157472 Recruiting
Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
Klinicki bolnicki centar Split /ID# 157473 Recruiting
Split, Croatia, 21000
Denmark
Bispebjerg Hospital /ID# 208945 Recruiting
Copenhagen NV, Hovedstaden, Denmark, 2400
Sjaellands Universitets Hospit /ID# 200033 Recruiting
Roskilde, Sjælland, Denmark, 4000
Odense Universitets Hospital /ID# 205602 Recruiting
Odense C, Syddanmark, Denmark, 5000
Hvidovre Hospital /ID# 202266 Recruiting
Hvidovre, Denmark, 2650
Egypt
Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848 Recruiting
Alexandria, Egypt, 21131
Air Force Specialized Hospital /ID# 170986 Not yet recruiting
Cairo, Egypt
National Liver Institute /ID# 171040 Not yet recruiting
Menoufiya, Egypt, 35111
France
Chu de Nice-Hopital L'Archet Ii /Id# 171577 Not yet recruiting
Nice CEDEX 3, Alpes-Maritimes, France, 06202
Hôpital Haut-Lévêque /ID# 171579 Not yet recruiting
Pessac CEDEX, Gironde, France, 33604
Hopital Beaujon /ID# 200092 Not yet recruiting
Clichy, Ile-de-France, France, 92110
CHU de SAINT ETIENNE - Hopital Nord /ID# 171580 Not yet recruiting
St. Priest En Jarez, Loire, France, 42270
CHU Amiens Picardie - Site Sud /ID# 171576 Not yet recruiting
Amiens Cedex 1, France, 80054
Germany
Universitatsklinikum Mannheim /ID# 162035 Not yet recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Universitaetsklinikum Erlangen /ID# 159354 Recruiting
Erlangen, Bayern, Germany, 91054
Uniklinik Koln /ID# 164991 Not yet recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Univ Hosp Schleswig-Holstein /ID# 159360 Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Universitaetsklinikum Ulm /ID# 164992 Not yet recruiting
Ulm, Thueringen, Germany, 89081
Praxis am Bayrischen Platz /ID# 159361 Recruiting
Berlin, Germany, 10825
Charite; Campus Benjamin Frank /ID# 210510 Not yet recruiting
Berlin, Germany, 12200
DRK Kliniken Berlin /ID# 166153 Recruiting
Berlin, Germany, 14050
Stadtisches Klinikum Braunschw /ID# 163687 Recruiting
Braunschweig, Germany, 38126
Agaplesion Markus Krankenhaus /ID# 159356 Recruiting
Frankfurt, Germany, 60341
Universitätsklinikum Freiburg /ID# 162034 Recruiting
Freiburg, Germany, 79106
Med Hochschule Hanover /ID# 162036 Not yet recruiting
Hannover, Germany, 30625
Praxis fuer Gastroenterologie /ID# 166152 Recruiting
Heidelberg, Germany, 69121
Gastroenterologie Opernstrasse /ID# 163683 Recruiting
Kassel, Germany, 34117
Klinikum Landshut /ID# 211551 Not yet recruiting
Landshut, Germany, 84034
Klinikum Lueneburg /ID# 163685 Recruiting
Lueneburg, Germany, 21339
Gastro Gemeinschaftspraxis /ID# 162033 Recruiting
Minden, Germany, 32423
LMU Klinikum der Universität München /ID# 210481 Not yet recruiting
Munich, Germany, 80337
Klinikum Univ Regensburg /ID# 163686 Recruiting
Regensburg, Germany, 93042
Universitatsklinikum Tubingen /ID# 159363 Not yet recruiting
Tuebingen, Germany, 72076
Greece
General Hospital of Athens Laiko /ID# 206440 Recruiting
Athens, Attiki, Greece, 115 27
Tzaneio general hospital of Piraeus /ID# 206439 Recruiting
Piraeus, Attiki, Greece, 18536
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915 Recruiting
Athens, Greece, 11527
University General Hospital of Heraklion "PA.G.N.I" /ID# 165216 Recruiting
Heraklion, Greece, 71110
General Hospital Nikaias-Piraeus St. Panteleimon /ID# 165218 Recruiting
Pireaus, Greece, 18454
Theageneio Anticancer Hospital /ID# 165217 Recruiting
Thessaloniki, Greece, 54639
Israel
Soroka Medical Center /ID# 171100 Recruiting
Be'er Sheva, HaDarom, Israel, 84101
Rabin Medical Center /ID# 167403 Recruiting
Petakh Tikva, Tel-Aviv, Israel, 4941492
Hadassah Ein Kerem Medical Ctr /ID# 171099 Recruiting
Jerusalem, Yerushalayim, Israel, 91120
Rambam Medical Center /ID# 171101 Not yet recruiting
Haifa, Israel, 3525408
Rambam Medical Center /ID# 171103 Recruiting
Haifa, Israel, 3525408
Shaare Zedek Medical Center /ID# 163544 Recruiting
Jerusalem, Israel, 91031
Shaare Zedek Medical Center /ID# 171102 Not yet recruiting
Jerusalem, Israel, 91031
Sheba Medical Center /ID# 171104 Not yet recruiting
Ramat Gan, Israel, 5262100
Sheba Medical Center /ID# 211278 Recruiting
Ramat Gan, Israel, 5262100
Italy
Universita di Catanzaro Magna Graecia /ID# 200125 Recruiting
Catanzaro, Calabria, Italy, 88100
Ospedale Sant Orsola Malpighi /ID# 155611 Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 201819 Recruiting
Modena, Emilia-Romagna, Italy, 41124
Policlinico Universitario Campus Bio-Medico /ID# 163992 Recruiting
Rome, Lazio, Italy, 00128
Azienda Ospedaliera San Camillo Forlanini /ID# 155612 Recruiting
Rome, Lazio, Italy, 00152
Azienda Policlinico Universitario Umberto I /ID# 171226 Not yet recruiting
Rome, Lazio, Italy, 00161
ASST Rhodense /ID# 211449 Not yet recruiting
Rho, Lombardia, Italy, 20017
Istituto Clinico Humanitas /ID# 155610 Not yet recruiting
Rozzano, Milano, Italy, 20089
A.O. Per L'Emergenza Cannizzaro /ID# 164036 Recruiting
Catania, Sicilia, Italy, 95126
Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 164041 Recruiting
Negrar, Verona, Italy, 37024
Ospedale Policlinico San Martino - IRCCS /ID# 164031 Recruiting
Genoa, Italy, 16132
Azienda Ospedaliera Ospedale N /ID# 170947 Recruiting
Milano, Italy, 20162
Azienda Ospedaliera Luigi Sacc /ID# 155607 Not yet recruiting
Milan, Italy, 20157
Policlinico Tor Vergata /ID# 158018 Recruiting
Rome, Italy, 00133
UOC Medicina Interna e Gastroe /ID# 155608 Recruiting
Rome, Italy, 168
Japan
Aichi Medical University Hosp /ID# 164332 Recruiting
Nagakute, Aichi, Japan, 4801195
Daido Clinic /ID# 211479 Recruiting
Nagoya-shi, Aichi, Japan, 457-8511
Nagoya University Hospital /ID# 164271 Recruiting
Nagoya-shi, Aichi, Japan, 466-8560
Nagoya City University Hospital /ID# 164331 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Toho University Sakura Medical Center /ID# 164254 Recruiting
Sakura-shi, Chiba, Japan, 285-8741
Fukuoka University Chikushi Hospital /ID# 209055 Recruiting
Chikushino, Fukuoka, Japan, 818-8502
Kurume University Hospital /ID# 164427 Recruiting
Kurume-shi, Fukuoka, Japan, 830-0011
Gifu University Hospital /ID# 208081 Recruiting
Gifu-shi, Gifu, Japan, 501-1194
National Hospital Organization Takasaki General Medical Center /ID# 164437 Recruiting
Takasaki-shi, Gunma, Japan, 370-0829
NHO Fukuyama Medical Center /ID# 164439 Recruiting
Fukuyama-shi, Hiroshima, Japan, 720-8520
Asahikawa Medical University Hospital /ID# 164433 Recruiting
Asahikawa-shi, Hokkaido, Japan, 078-8510
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-0033
Sapporo Medical Univ Hosp /ID# 164432 Recruiting
Sapporo-shi, Hokkaido, Japan, 060-8543
Aoyama Clinic /ID# 164425 Recruiting
Kobe, Hyogo, Japan, 650-0015
Kanazawa University Ho /ID# 169224 Recruiting
Kanazawa, Ishikawa, Japan, 92086-41
Gokeikai Ofuna Chuo Hospital /ID# 169300 Recruiting
Kamakura-shi, Kanagawa, Japan, 2470056
Mie University Hospital /ID# 203633 Recruiting
Tsu-shi, Mie, Japan, 514-8507
Tohoku University Hospital /ID# 164430 Recruiting
Sendai-shi, Miyagi, Japan, 980-8574
Nagasaki University Hospital /ID# 202674 Recruiting
Nagasaki-shi, Nagasaki, Japan, 852-8501
Saga University Hospital /ID# 209396 Recruiting
Saga-shi, Saga, Japan, 849-8501
Tokito Clinic /ID# 164253 Recruiting
Saitama-shi, Saitama, Japan, 336-0963
Shiga University of Medical Science Hospital /ID# 164440 Recruiting
Otsu, Shiga, Japan, 520-2192
Medical Hospital of Tokyo Medical and Dental University /ID# 164258 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Kyorin University Hospital /ID# 164259 Recruiting
Mitaka-shi, Tokyo, Japan, 181-8611
Keio University Hospital /ID# 203629 Recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Yamagata University Hospital /ID# 171474 Recruiting
Yamagata-shi, Yamagata, Japan, 990-9585
Hiroshima University Hospital /ID# 164426 Recruiting
Hiroshima, Japan, 734-8551
Tokai University Hospital /ID# 209204 Recruiting
Isehara, Japan, 259-1143
Sameshima Hospital /ID# 211181 Recruiting
Kagoshima, Japan
Nara Medical Univ Hospital /ID# 169225 Recruiting
Kashihara, Japan, 634-0813
The Jikei University Hospital /ID# 164434 Recruiting
Minato-ku, Japan, 105-8471
Kitasato University Kitasato I /ID# 164256 Recruiting
Minato-ku, Japan, 108-8642
The Hospital of Hyogo College /ID# 164424 Recruiting
Nishinomiya-shi, Japan, 663-8501
Kitasato University Hospital /ID# 169226 Recruiting
Sagamihara-shi, Japan, 252-0375
NHO Shizuoka Medical Center /ID# 164435 Recruiting
Shimizu-sho, Japan
Fujita Health University Hosp /ID# 164261 Recruiting
Toyoake, Japan, 470-1192
Wakayama Medical University /ID# 169487 Recruiting
Wakayama, Japan, 641-8510
JP Red Cross Wakayama Med Ctr /ID# 171195 Recruiting
Wakayama, Japan
Yokkaichi Hazu Medical Center /ID# 164441 Recruiting
Yokkaichi-shi, Japan, 510-0016
Showa Univ Fujigaoka Hosp /ID# 209555 Recruiting
Yokohama-shi, Japan, 227-0043
Korea, Republic of
Dong-A University Hospital /ID# 158705 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 49201
Pusan National University Hosp /ID# 158711 Recruiting
Busan, Busan Gwang Yeogsi, Korea, Republic of, 602-739
Yeungnam University Med Ctr /ID# 158703 Recruiting
Daegu, Daegu Gwang Yeogsi, Korea, Republic of, 42415
CHA bundang medical center, CHA University /ID# 158710 Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13496
St. Vincent's Hospital /ID# 158706 Recruiting
Suwon, Gyeonggido, Korea, Republic of, 16247
Kangbuk Samsung Hospital /ID# 158707 Recruiting
Jongno-Gu, Seoul Teugbyeolsi, Korea, Republic of, 03181
Severance Hospital /ID# 158701 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Samsung Medical Center /ID# 158704 Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Haeundae Paik Hospital /ID# 203028 Recruiting
Busan, Korea, Republic of, 48108
Hanyang University Guri Hosp /ID# 158702 Recruiting
Guri-si, Korea, Republic of, 471-701
Latvia
Riga East Clinical Univ Hosp /ID# 163802 Not yet recruiting
Riga, Latvia, 1038
P. Stradins Clinical Univ Hosp /ID# 163803 Recruiting
Riga, Latvia, LV-1002
Lithuania
Hospital of Lithuanian Univers /ID# 170714 Recruiting
Kovno, Kaunas, Lithuania, 50161
Klaipeda Seamens Hospital /ID# 170847 Not yet recruiting
Klaipeda, Lithuania, LT-92288
Vilnius University Hospital /ID# 170614 Recruiting
Vilnius, Lithuania, LT-08661
Malaysia
UKM Medical Centre /ID# 200635 Not yet recruiting
Kuala Lumpur, Selangor, Malaysia, 56000
Mexico
JM Research /ID# 203593 Not yet recruiting
Cuernavaca, Morelos, Mexico, 62290
Health Pharma Professional Research S.A de C.V /ID# 203597 Not yet recruiting
Del. Benito Juárez, Mexico, 03810
Unidad de Atencion Medica e Investigacion en Salud /ID# 203595 Not yet recruiting
Merida Yucatan, Mexico, 97000
Netherlands
Academisch Medisch Centrum /ID# 157959 Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Elisabeth Tweesteden Ziekenhuis /ID# 163767 Recruiting
Tilburg, Netherlands, 5022 GC
New Zealand
Christchurch Hospital /ID# 205342 Recruiting
Christchurch, Canterbury, New Zealand, 8011
Waikato Hospital /ID# 212789 Not yet recruiting
Hamilton, Waikato, New Zealand, 3204
Hutt Valley Dist Health Board /ID# 212786 Not yet recruiting
Lower Hutt, New Zealand, 5020
Wellington Hospital (Capital and Coast District Health Board) /ID# 205343 Recruiting
Wellington, New Zealand, 6021
Poland
Vistamed /ID# 210105 Completed
Wrocław, Dolnoslaskie, Poland, 53-149
Centrum Medyczne Plejady /ID# 170633 Recruiting
Krakow, Malopolskie, Poland, 30-363
Centrum Zdrowia MDM /ID# 170597 Recruiting
Warsaw, Mazowieckie, Poland, 00-635
Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 170601 Recruiting
Warszawa, Mazowieckie, Poland, 02-507
Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie w Warszawie /ID# 170600 Recruiting
Warszawa, Mazowieckie, Poland, 02-781
NZOZ All-Medicus /ID# 170596 Recruiting
Katowice, Slaskie, Poland, 40-659
NZOZ Vitamed /ID# 213283 Not yet recruiting
Bydgoszcz, Poland, 85-079
Portugal
Centro Hospitalar do Algarve - Hospital de Portimão /ID# 166551 Recruiting
Portimao, Faro, Portugal, 8500-338
Centro Hosp de Lisboa Central /ID# 165582 Not yet recruiting
Lisbon, Lisboa, Portugal, 1169-050
Hospital Garcia de Orta, E.P.E /ID# 165583 Recruiting
Almada, Setubal, Portugal, 2805-267
Centro Hospitalar e Universitário de Coimbra, EPE /ID# 166054 Recruiting
Coimbra, Portugal, 3000-075
HSOG - Hospital Senhora da Oli /ID# 165580 Recruiting
Guimaraes, Portugal, 4835-044
Centro Hospitalar de Sao Joao, EPE /ID# 165581 Recruiting
Porto, Portugal, 4200-319
Centro Hospitalar de Entre o D /ID# 166052 Recruiting
Santa Maria Da Feira, Portugal, 4520-211
Centro Hosp de Tondela-Viseu /ID# 166053 Not yet recruiting
Viseu, Portugal, 3504 - 509
Puerto Rico
San Jorge Children Hospital /ID# 166954 Recruiting
San Juan, Puerto Rico, 00912-3310
Romania
Institutul Clinic Fundeni /ID# 171264 Not yet recruiting
Bucharest, Romania, 22328
Cabinet Particular Policlinic Algomed /ID# 171266 Not yet recruiting
Timisoara, Romania, 300002
Centrul Medical Tuculanu SRL /ID# 171268 Not yet recruiting
Timisoara, Romania, 300168
Russian Federation
GBUZ Interdisctrict Multidisciplinary Hospital /ID# 203335 Recruiting
Anzorey, Kabardino-Balkarskaya Respublika, Russian Federation, 361350
Immanuel Kant Baltic Federal University /ID# 204888 Recruiting
Kaliningrad, Kaliningradskaya Oblast, Russian Federation, 236016
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev /ID# 165750 Recruiting
Kemerovo, Kemerovskaya Oblast, Russian Federation, 650066
LLC "Korolev Medicina" /ID# 208946 Recruiting
Korolev, Moskovskaya Oblast, Russian Federation, 141077
Regional Clinical Hospital #1 /ID# 165754 Recruiting
Tyumen, Tyumenskaya Oblast, Russian Federation, 625023
Clinic of New Technologies of /ID# 203369 Recruiting
Dzerzhinskiy, Russian Federation, 140091
Sechenov First Moscow Medical /ID# 204978 Recruiting
Moscow, Russian Federation, 119992
Scien Ctr Coloproctology Rosme /ID# 203512 Recruiting
Moscow, Russian Federation, 123423
Central Clinical Hosp 2 /ID# 204917 Recruiting
Moscow, Russian Federation, 129128
PMI Euromedservice /ID# 204892 Recruiting
Pushkin, Russian Federation, 196603
International Medical Center SOGAZ /ID# 206727 Recruiting
Sankt-Peterburg, Russian Federation, 191186
City Clinical Hospital #40 /ID# 203370 Recruiting
St. Petersburg, Russian Federation, 197706
Ulyanovsk Regional Clin Hosp /ID# 203368 Recruiting
Ulyanovsk, Russian Federation, 432018
Serbia
Clinical Center Serbia /ID# 200152 Recruiting
Belgrade, Beograd, Serbia, 11000
Clinical Hosp Center Zvezdara /ID# 200151 Recruiting
Belgrade, Beograd, Serbia, 11000
Clin Hosp Ctr Bezanijska Kosa /ID# 202059 Recruiting
Belgrade, Beograd, Serbia, 11080
Clinical Center Kragujevac /ID# 156913 Not yet recruiting
Kragujevac, Sumadijski Okrug, Serbia, 34000
Singapore
Singapore General Hospital /ID# 204227 Not yet recruiting
Singapore, Singapore, 169608
KL Ling Gastroenterology and Liver Clinic /ID# 205738 Recruiting
Singapore, Singapore, 228510
Slovakia
FN s poliklinikou F.D. Rooseve /ID# 164347 Recruiting
Banska Bystrica, Slovakia, 97517
KM Management s.r.o, Nitra, SK /ID# 206602 Recruiting
Nitra, Slovakia, 949 01
Gastro I.S.R.O. /ID# 164346 Recruiting
Presov, Slovakia, 08001
Slovenia
Univ Medical Ctr Ljubljana /ID# 210627 Recruiting
Ljubljana, Slovenia, 1000
South Africa
Farmovs (Pty) Ltd /Id# 207537 Not yet recruiting
Bloemfontein, Free State, South Africa, 9301
Wits Clinical Research Site /ID# 171136 Not yet recruiting
Johannesburg, Gauteng, South Africa, 2193
Mediclinic Constantiaberg /ID# 171137 Recruiting
Cape Town, Western Cape, South Africa, 7800
Dr JP Wright /ID# 171138 Recruiting
Cape Town, South Africa, 7708
Spain
Hospital Alvaro Cunqueiro /ID# 167360 Not yet recruiting
Vigo, Pontevedra, Spain, 36312
Hospital Universitario Parc Tauli /ID# 159461 Recruiting
Barcelona, Spain, 08028
Hospital Clinic de Barcelona /ID# 159439 Not yet recruiting
Barcelona, Spain, 08036
Hospital Universitario Reina S /ID# 167058 Recruiting
Cordoba, Spain, 14004
Hospital Universitario de Cabu /ID# 170748 Recruiting
Gijon, Spain, 33394
Hospital General Universitario Gregorio Maranon /ID# 161146 Not yet recruiting
Madrid, Spain, 28007
Hospital Universitario La Paz /ID# 159459 Recruiting
Madrid, Spain, 28046
Hosp Univ Puerta de Hierro /ID# 159443 Recruiting
Majadahonda, Spain, 28222
Hospital Clinico Univ de Salamanca /ID# 159446 Not yet recruiting
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena /ID# 159968 Recruiting
Sevilla, Spain, 41009
Hospital de Manises /ID# 167059 Not yet recruiting
Valencia, Spain, 46940
Hospital Univ Miguel Servet /ID# 159445 Recruiting
Zaragoza, Spain, 50009
Sweden
Alingsås lasarett /ID# 202074 Recruiting
Alingsås, Vastra Gotalands Lan, Sweden, 441 33
SU Molndal. /ID# 202843 Recruiting
Molndal, Sweden, 431 80
Danderyds sjukhus AB /ID# 202035 Recruiting
Stockholm, Sweden, 182 88
Switzerland
University Hospital Zurich /ID# 202910 Recruiting
Zurich, Switzerland, 8091
Taiwan
National Taiwan University Hospital /ID# 162187 Recruiting
Taipei City, Taipei, Taiwan, 100
Chung Shan Medical University /ID# 163651 Recruiting
Taichung City, Taiwan, 40201
Taichung Veterans General Hosp /ID# 163649 Recruiting
Taichung City, Taiwan, 40705
Taipei Veterans General Hosp /ID# 163650 Recruiting
Taipei City, Taiwan, 11217
Turkey
Acıbadem Kozyatagı Hospital /ID# 213276 Not yet recruiting
Kadiköy, Istanbul, Turkey, 34742
Erciyes University Medical Fac /ID# 171291 Recruiting
Melikgazi, Kayseri, Turkey, 38030
Ankara Univ Medical Faculty /ID# 167210 Not yet recruiting
Ankara, Turkey, 6100
Inonu Universitesi Turgut Ozal /ID# 203981 Recruiting
Battalgazi/malatya, Turkey, 44280
Uludag University Medical Faculty /ID# 204182 Recruiting
Bursa, Turkey, 16059
Fırat University Medical Facul /ID# 171292 Not yet recruiting
Elazig, Turkey, 23100
Istanbul University Cerrahpasa Medical Faculty /ID# 167207 Recruiting
Istanbul, Turkey, 34098
Marmara University Medical Fac /ID# 171293 Not yet recruiting
Istanbul, Turkey, 34899
Sisli Etfal Train & Res Hosp /ID# 171409 Recruiting
Sisli, Turkey, 34371
Ukraine
Medical Centre of OK!Clinic of International Institute of Clinical Trials /ID# 205482 Recruiting
Kiev, Kyivska Oblast, Ukraine, 02091
Regional Clinical Hospital /ID# 203367 Not yet recruiting
Ivano-frankivsk, Ukraine, 76018
United Kingdom
RD&E Hospital /ID# 157587 Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Barnsley Hospital NHS Foundation Trust /ID# 202770 Recruiting
Barnsley, United Kingdom, S75 2EP
Royal United Hospitals Bath /ID# 157592 Not yet recruiting
Bath, United Kingdom, BA1 3NG
Univ Hospitals Birmingham NHS Foundation trust /ID# 157588 Not yet recruiting
Birmingham, United Kingdom, B15 2TG
Addenbrookes Hospital /ID# 158040 Recruiting
Cambridge, United Kingdom, CB2 0SP
Western General Hospital /ID# 208802 Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Royal Liverpool and Broadgreen /ID# 203858 Recruiting
Liverpool, United Kingdom, L7 8XP
Barts and the London NHS Trust /ID# 157590 Recruiting
London, United Kingdom, EC1A 7BE
King's College Hospital NHS /ID# 158766 Recruiting
London, United Kingdom, SE5 9RS
St. George's Healthcare NHS /ID# 208378 Recruiting
London, United Kingdom, SW17 0QT
The Newcastle Upon Tyne Hospitals NHS Foundation Trust' /ID# 158041 Recruiting
Newcastle Upon Tyne, United Kingdom, NE1 4LP
Univ Hosp Southampton NHS /ID# 210813 Not yet recruiting
Southampton, United Kingdom, SO166YD
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: NCT03398148     History of Changes
Other Study ID Numbers: M16-067
2016-004677-40 ( EudraCT Number )
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 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

Layout table for additional information
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:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs