search
Back to results

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) (SEQUENCE)

Primary Purpose

Crohn's Disease (CD)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risankizumab
Risankizumab
Ustekinumab
Ustekinumab
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease (CD) focused on measuring Crohn's Disease (CD), Risankizumab, Ustekinumab, SKYRIZI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline.
  • Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
  • Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD).
  • Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies.

Exclusion Criteria:

  • Current diagnosis of ulcerative colitis or indeterminate colitis.
  • Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol).
  • Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab).
  • Currently know complications of CD (strictures, short bowel, etc).

Sites / Locations

  • Advanced Gastroenterology, P.C /ID# 224396
  • Southern California Res. Ctr. /ID# 223484
  • Hoag Memorial Hosp Presbyterian /ID# 224373
  • United Medical Doctors /ID# 223486
  • TLC Clinical Research Inc /ID# 223467
  • UC Davis Medical Center /ID# 225700
  • University of California, San Francisco /ID# 223621
  • Western Connecticut Medical Group /ID# 223478
  • Medical Research Center of CT /ID# 223540
  • Yale Univ Digestive Diseases /ID# 224463
  • Omega Research Maitland, LLC /ID# 223463
  • Nature Coast Clinical Research - Inverness /ID# 223600
  • University of Miami /ID# 223496
  • Gastroenterology Group Naples /ID# 223516
  • Advanced Research Institute, Inc /ID# 223470
  • Endoscopic Research, Inc. /ID# 223505
  • University of South Florida /ID# 224733
  • Atlanta Gastro Assoc /ID# 223537
  • Gastroenterology Associates of Central Georgia, LLC /ID# 223525
  • The University of Chicago DCAM /ID# 223520
  • NorthShore University HealthSystem /ID# 223538
  • Southwest Gastroenterology /ID# 223509
  • University of Louisville /ID# 223471
  • GI Alliance /ID# 223508
  • Nola Research Works, LLC /ID# 223489
  • Louisiana Research Center, LLC /ID# 223503
  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499
  • Gastro Center of Maryland /ID# 223518
  • Massachusetts General Hospital /Id# 224335
  • Beth Israel Deaconess Medical Center /ID# 228094
  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597
  • AA Medical Research Center - Flint /ID# 224384
  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465
  • Mayo Clinic - Rochester /ID# 223506
  • Las Vegas Medical Research /ID# 223533
  • Univ New Mexico /ID# 223515
  • NY Scientific /ID# 223479
  • Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048
  • Intercity Advanced Gastroentertology Center /ID# 224313
  • North Shore University Hospital /ID# 224356
  • The Mount Sinai Hospital /ID# 223687
  • Columbia Univ Medical Center /ID# 224215
  • Lenox Hill Hospital /ID# 223534
  • Univ NC Chapel Hill /ID# 224405
  • Wake Forest Baptist Medical Center /ID# 224406
  • Plains Clinical Research Center, LLC /ID# 223522
  • University of Cincinnati /ID# 224614
  • Cleveland Clinic Main Campus /ID# 223691
  • DSI Research, LLC /ID# 234116
  • Hightower Clinical /ID# 223566
  • Digestive Disease Specialists /ID# 223528
  • Penn State Milton S. Hershey Medical Center /ID# 224216
  • Guthrie Medical Group, PC /ID# 223910
  • Digestive Disease Associates, LTD /ID# 223462
  • Medical University of South Carolina /ID# 223485
  • Consultants in Gastroenterology - Columbia NE /ID# 224263
  • Gastroenterology Associates, P.A. of Greenville /ID# 223497
  • Gastro One /ID# 223539
  • Vanderbilt University Medical Center /ID# 224610
  • Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512
  • DHAT Research Institute /ID# 223521
  • Vilo Research Group Inc /ID# 223513
  • Baylor College of Medicine - Baylor Medical Center /ID# 223488
  • Clinical Associates in Research Therapeutics of America, LLC /ID# 223510
  • Southern Star Research Institute, LLC /ID# 223598
  • Texas Digestive Disease Consultants - Southlake /ID# 224264
  • Tyler Research Institute, LLC /ID# 223469
  • University of Vermont Medical Center /ID# 224047
  • Hunter Holmes McGuire VA Medical Center /ID# 223586
  • Virginia Mason Medical Center /ID# 224253
  • Harborview Medical Center /ID# 224464
  • West Virginia University Hospitals /ID# 223501
  • Hospital Italiano de Buenos Aires /ID# 224550
  • CINME Centro de Investigaciones Metabolicas /ID# 223447
  • Gedyt /ID# 224698
  • Hospital Britanico de Buenos Aires /ID# 223432
  • Cemic /Id# 223670
  • Sanatorio 9 de Julio /ID# 226086
  • Hospital Privado Univesitario /ID# 223433
  • Wollongong Hospital /ID# 224688
  • Mater Misericordiae Limited /ID# 223642
  • Griffith University /ID# 223641
  • Lyell McEwin Hospital /ID# 223643
  • Monash Medical Centre /ID# 224599
  • Universitaetsklinikum St. Poelten /ID# 223437
  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440
  • Medizinische Universitaet Wien /ID# 223438
  • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 223902
  • UCL Saint-Luc /ID# 223900
  • CHU UCL Namur - site Godinne /ID# 223905
  • UZ Gent /ID# 223899
  • Universitair Ziekenhuis Leuven /ID# 223901
  • AZ-Delta /ID# 223896
  • AZ Maria Middelares /ID# 223908
  • CHU de Liege /ID# 223904
  • Groupe Sante CHC - Clinique du MontLegia /ID# 223898
  • ZNA - Jan Palfijn /ID# 223907
  • Vitaz /Id# 224511
  • Upeclin Fmb - Unesp /Id# 223234
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 223233
  • Faculdade de Medicina do ABC /ID# 223231
  • Kaiser Clinica e Hospital Dia /ID# 223232
  • UMHAT Kaspela EOOD /ID# 223415
  • Second MHAT Sofia /ID# 223425
  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757
  • UMHAT Tsaritsa Joanna - ISUL /ID# 223822
  • University of Calgary /ID# 223750
  • Allen Whey Khye Lim Professional Corporation /ID# 223755
  • Covenant Health /ID# 223753
  • Fraser Clinical Trials Inc /ID# 223742
  • Percuro Clinical Research, Ltd /ID# 223747
  • QEII - Health Sciences Centre /ID# 223748
  • London Health Sciences Center- University Hospital /ID# 223741
  • Scott Shulman Medicine Professional Corporation /ID# 223754
  • Mount Sinai Hospital /ID# 223752
  • Axler, Toronto, ON. Canada /ID# 223740
  • CISSS de la Monteregie /ID# 224399
  • CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744
  • CHUS - Hopital Fleurimont /ID# 224819
  • Montreal General Hospital- McGill University Health Center /ID# 223743
  • Sociedad de Servicios Medicos Walsen Galmez /ID# 224032
  • Hospital Guillermo Grant Benavente de Concepción /ID# 223668
  • Hospital Las Higueras /ID# 223669
  • Anhui Provincial Hospital /ID# 224832
  • Peking University Third Hospital /ID# 224479
  • Chongqing General Hospital /ID# 232305
  • Zhongshan Hospital Xiamen University /ID# 224663
  • Zhujiang Hospital of Southern Medical University /ID# 224524
  • The Sixth Affiliated Hosp Sun /ID# 224416
  • The Second Affiliated Hospital of Zhengzhou University /ID# 224528
  • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545
  • Tongji Hospital Tongji Medical College of HUST /ID# 224428
  • Renmin Hospital of Wuhan University /ID# 224525
  • The Third Xiangya Hospital of Central South University /ID# 224754
  • Changzhou No.2 People's Hospital /ID# 238965
  • Nanjing Drum Tower Hospital /ID# 224746
  • Wuxi People's Hospital /ID# 224426
  • The First Affiliated Hospital of Nanchang University /ID# 224507
  • Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420
  • West China Hospital, Sichuan University /ID# 224786
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 224662
  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421
  • The Second Xiangya Hospital of Central South University /ID# 224684
  • Shengjing Hospital of China Medical University /ID# 224478
  • Nemocnice Ceske Budejovice a.s. /ID# 224219
  • Hepato-Gastroenterologie HK, s.r.o. /ID# 223277
  • Nemocnice Pardubickeho kraje, a.s. /ID# 223256
  • Axon Clinical, s.r.o. /ID# 223260
  • Nemocnice Horovice - NH Hospital a.s /ID# 223276
  • ISCARE a.s. /ID# 223279
  • Chu de Nice-Hopital L'Archet Ii /Id# 223763
  • CHU Clermont-Ferrand /ID# 224529
  • APHM - Hopital Nord /ID# 223869
  • CHU Bordeaux - Hopital Haut Leveque /ID# 223764
  • CHRU Lille - Hopital Claude Huriez /ID# 223765
  • CHU Montpellier - Hôpital Saint Eloi /ID# 223860
  • Hopital Beaujon /ID# 223863
  • Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249859
  • CHU de SAINT ETIENNE - Hopital Nord /ID# 223768
  • CHU Reims - Hôpital Robert Debre /ID# 224530
  • CHRU Nancy - Hopitaux de Brabois /ID# 223767
  • CHU de Nantes, Hotel Dieu -HME /ID# 241098
  • CHU Grenoble - Hopital Michallon /ID# 224091
  • Clinique Jules Verne /ID# 223870
  • Polyclinique Grand Sud /ID# 224092
  • Hopital Universitaire Purpan Hopital Rangueil /ID# 224732
  • Universitaetsklinikum Freiburg /ID# 223406
  • Universitatsklinikum Mannheim /ID# 223410
  • Universitaetsklinikum Ulm /ID# 223400
  • Universitaetsklinikum Erlangen /ID# 223404
  • Universitatsklinik Regensburg /ID# 223407
  • Universitaetsklinikum Frankfurt /ID# 223396
  • Praxiszentrum fuer Gastroenterologie /ID# 223409
  • Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395
  • Krankenhaus Waldfriede /ID# 223397
  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 223405
  • Praxis Dr. Michael Mross /ID# 229110
  • MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411
  • DRK Kliniken Berlin Westend /ID# 223412
  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403
  • Agaplesion Markus Krankenhaus /ID# 223673
  • Medizinische Hochschule Hannover /ID# 223402
  • EUGASTRO GmbH /ID# 223401
  • Klinikum Lueneburg /ID# 223408
  • Otto-von-Guericke-Universitaet /ID# 223413
  • Medizinisches Versorgungszentrum Portal 10 /ID# 224552
  • General Hospital of Athens Ippokratio /ID# 223344
  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342
  • University General Hospital of Heraklion PA.G.N.I /ID# 223336
  • General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338
  • University General Hospital of Ioannina /ID# 223339
  • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340
  • General Hospital of Thessaloniki Hippokrateio /ID# 223887
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
  • Debreceni Egyetem Klinikai Kozpont /ID# 223773
  • Clinexpert Kft /ID# 223775
  • Semmelweis Egyetem /ID# 223772
  • Clinfan Szolgaltato Kft. /ID# 224751
  • Soroka University Medical Center /ID# 223556
  • The Chaim Sheba Medical Center /ID# 223557
  • Tel Aviv Sourasky Medical Center /ID# 223551
  • The Edith Wolfson Medical Center /ID# 227652
  • Shaare Zedek Medical Center /ID# 223549
  • Rabin Medical Center /ID# 223558
  • Assaf Harofeh Medical Center /ID# 224686
  • Ospedale Policlinico San Martino /ID# 223329
  • Azienda Ospedaliera San Camillo Forlanini /ID# 223325
  • Policlinico Agostino Gemelli /ID# 223323
  • Ospedale San Raffaele IRCCS /ID# 241167
  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332
  • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330
  • Azienda Ospedaliera G. Brotzu /ID# 241165
  • Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474
  • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324
  • A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333
  • Kangbuk Samsung Hospital /ID# 223452
  • Dong-A University Hospital /ID# 223455
  • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456
  • Samsung Medical Center /ID# 223453
  • Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179
  • BRCR Global México /ID# 223970
  • Centro Medico Zambrano Hellion /ID# 224025
  • Medical Care & Research SA de CV /ID# 223974
  • Faicic S de Rl de Cv /Id# 226990
  • Radboud Universitair Medisch Centrum /ID# 233750
  • Academisch Medisch Centrum /ID# 223228
  • Elisabeth Tweesteden Ziekenhuis /ID# 223229
  • Universitair Medisch Centrum Utrecht /ID# 223696
  • Gastromed Sp. z o.o /ID# 223705
  • Malopolskie Centrum Kliniczne /ID# 223708
  • NZOZ Vivamed Jadwiga Miecz /ID# 223706
  • Institutul Clinic Fundeni /ID# 223914
  • Sana Monitoring /Id# 223682
  • Spitalul Clinic Colentina /ID# 223680
  • Univ Emergency Hosp Bucharest /ID# 223579
  • Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017
  • Targu Mures Emergency Clinical County Hospital /ID# 223613
  • Cabinet Particular Policlinic Algomed /ID# 223578
  • Immanuel Kant Baltic Federal University /ID# 224224
  • National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222
  • City Clinical Hospital No. 31 /ID# 224223
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302
  • KM Management, spol. s.r.o. /ID# 223304
  • Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580
  • GASTRO I., s.r.o. /ID# 223303
  • Lenasia Clinical Trial Centre /ID# 224306
  • Spoke Research Inc /ID# 223803
  • Dr MJ Prins /ID# 224304
  • Private Practice Dr MN Rajabally /ID# 223805
  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356
  • Hospital Clínico Universitario de Santiago-CHUS /ID# 226554
  • Hospital Universitario Central de Asturias /ID# 223368
  • Hospital Universitario Germans Trias i Pujol /ID# 223436
  • Hospital Universitario de Bellvitge /ID# 225719
  • Hospital Universitario de Fuenlabrada /ID# 223371
  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 223319
  • Hospital General Universitario de Alicante Doctor Balmis /ID# 223552
  • Hospital Clinic de Barcelona /ID# 223355
  • Hospital General Universitario Gregorio Maranon /ID# 223317
  • Hospital Clinico Universitario San Carlos /ID# 223367
  • Hospital Universitario La Paz /ID# 223318
  • Hospital Universitario Virgen Macarena /ID# 223315
  • Hospital Universitario Virgen del Rocio /ID# 223476
  • Hospital Clinico Universitario de Valencia /ID# 223321
  • Hospital Universitario y Politecnico La Fe /ID# 223314
  • Karolinska University Hospital Solna /ID# 223423
  • GHP Stockholm Gastro Center /ID# 223420
  • Falu Lasarett /ID# 227222
  • Danderyds sjukhus AB /ID# 223363
  • Universitätsspital Basel /ID# 223711
  • Universitatsspital Zurich /ID# 223712
  • Inselspital, Universitätsspital Bern /ID# 223590
  • Gazi Universitesi Tip Fakultes /ID# 223386
  • Ankara Univ Medical Faculty /ID# 223388
  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 223387
  • Mersin University Medical /ID# 223385
  • Kyiv Municipal Clinical Hospital #18 /ID# 223700
  • Lviv Regional Clinical Hospital /ID# 223661
  • Medical Center of LLC DIASERVIS /ID# 224249
  • University Hospital Southampton NHS Foundation Trust /ID# 224351
  • East and North Hertfordshire NHS Trust /ID# 224607
  • Barts Health NHS Trust /ID# 223651
  • Guys and St Thomas NHS Foundation Trust /ID# 223647
  • Nottingham University Hospitals NHS Trust /ID# 224179
  • Oxford University Hospitals NHS Foundation Trust /ID# 223645
  • NHS Greater Glasgow and Clyde /ID# 223653
  • Belfast Health and Social Care Trust /ID# 224023
  • Cambridge University Hospitals NHS Foundation Trust /ID# 223648
  • NHS Lothian /ID# 223646
  • Royal Devon and Exeter NHS Foundation Trust /ID# 223644
  • Calderdale and Huddersfield NHS Foundation Trust /ID# 223654
  • King's College Hospital NHS Foundation Trust /ID# 223649
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655
  • Northern Care Alliance NHS Group /ID# 223650
  • NHS Forth Valley /ID# 224657
  • St George's University Hospitals NHS Foundation Trust /ID# 223656

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Risankizumab Dose A Followed by Dose B

Ustekinumab

Arm Description

Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.

Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Clinical Remission at Week 24
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
Number of Participants Reporting Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Secondary Outcome Measures

Percentage of Participants Achieving Clinical Remission at Week 48
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Percentage of Participants Achieving Endoscopic Response at Week 48
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Percentage of Participants Achieving Endoscopic Response at Week 24
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Percentage of Participants Achieving Steroid-Free Endoscopic Remission
Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.
Percentage of Participants Achieving Steroid-Free Clinical Remission
Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.

Full Information

First Posted
August 20, 2020
Last Updated
September 25, 2023
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT04524611
Brief Title
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
Acronym
SEQUENCE
Official Title
A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
February 11, 2028 (Anticipated)
Study Completion Date
February 11, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease (CD)
Keywords
Crohn's Disease (CD), Risankizumab, Ustekinumab, SKYRIZI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
527 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Risankizumab Dose A Followed by Dose B
Arm Type
Experimental
Arm Description
Participants will receive intravenous risankizumab dose A at Week 0, 4 ,8 followed by subcutaneous (SC) risankizumab dose B every 8 weeks through Week 48. Participants who complete the Week 48 visit will continue SC risankizumab for up to an additional 220 weeks.
Arm Title
Ustekinumab
Arm Type
Active Comparator
Arm Description
Participants will receive weight-based intravenous ustekinumab at Week 0 followed by subcutaneous ustekinumab every 8 weeks through Week 48.
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, SKYRIZI
Intervention Description
Intravenous (IV) Infusion
Intervention Type
Drug
Intervention Name(s)
Risankizumab
Other Intervention Name(s)
ABBV-066, SKYRIZI
Intervention Description
Subcutaneous (SC) Injection
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission at Week 24
Description
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Time Frame
Week 24
Title
Percentage of Participants Achieving Endoscopic Remission
Description
Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) <= 4 and at least a 2-point reduction versus Baseline and no sub score greater than 1 in any individual variable, as scored by a central reviewer.
Time Frame
Week 48
Title
Number of Participants Reporting Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time Frame
Up to 220 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission at Week 48
Description
Clinical remission is defined as Crohn's disease activity index (CDAI)<150.
Time Frame
Week 48
Title
Percentage of Participants Achieving Endoscopic Response at Week 48
Description
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time Frame
Week 48
Title
Percentage of Participants Achieving Endoscopic Response at Week 24
Description
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Time Frame
Week 24
Title
Percentage of Participants Achieving Steroid-Free Endoscopic Remission
Description
Steroid-free endoscopic remission is defined as participants with endoscopic remission and not receiving steroids at Week 48.
Time Frame
Week 48
Title
Percentage of Participants Achieving Steroid-Free Clinical Remission
Description
Steroid-free clinical remission is defined as participants with clinical remission and not receiving steroids at Week 48.
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of Crohn's disease (CD) for at least 3 months prior to Baseline. Crohn's disease activity index (CDAI) score 220 - 450 at Baseline. Confirmed diagnosis of moderate to severe Crohn's Disease as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic score for CD (SES-CD). Demonstrated intolerance or inadequate response to one or more anti-tumor necrosis factor (TNF) therapies. Exclusion Criteria: Current diagnosis of ulcerative colitis or indeterminate colitis. Receipt of CD approved biologic agents prior to Baseline (as detailed in protocol), or any investigational biologic or other agent or procedure prior to Baseline (as detailed in protocol). Prior exposure to p19 and/or p40 inhibitors (e.g., risankizumab and ustekinumab). Currently know complications of CD (strictures, short bowel, etc).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Gastroenterology, P.C /ID# 224396
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224-1636
Country
United States
Facility Name
Southern California Res. Ctr. /ID# 223484
City
Coronado
State/Province
California
ZIP/Postal Code
92118-1408
Country
United States
Facility Name
Hoag Memorial Hosp Presbyterian /ID# 224373
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
United Medical Doctors /ID# 223486
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3309
Country
United States
Facility Name
TLC Clinical Research Inc /ID# 223467
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UC Davis Medical Center /ID# 225700
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, San Francisco /ID# 223621
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Western Connecticut Medical Group /ID# 223478
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Medical Research Center of CT /ID# 223540
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Yale Univ Digestive Diseases /ID# 224463
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 223463
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
Nature Coast Clinical Research - Inverness /ID# 223600
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452-4717
Country
United States
Facility Name
University of Miami /ID# 223496
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Gastroenterology Group Naples /ID# 223516
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Research Institute, Inc /ID# 223470
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Endoscopic Research, Inc. /ID# 223505
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of South Florida /ID# 224733
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta Gastro Assoc /ID# 223537
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 223525
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
The University of Chicago DCAM /ID# 223520
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
NorthShore University HealthSystem /ID# 223538
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Southwest Gastroenterology /ID# 223509
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
University of Louisville /ID# 223471
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
GI Alliance /ID# 223508
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Nola Research Works, LLC /ID# 223489
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Louisiana Research Center, LLC /ID# 223503
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 223499
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland /ID# 223518
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Massachusetts General Hospital /Id# 224335
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 228094
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 223597
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
AA Medical Research Center - Flint /ID# 224384
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 223465
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 223506
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Las Vegas Medical Research /ID# 223533
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Univ New Mexico /ID# 223515
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
NY Scientific /ID# 223479
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 224048
City
Burnt Hills
State/Province
New York
ZIP/Postal Code
12027
Country
United States
Facility Name
Intercity Advanced Gastroentertology Center /ID# 224313
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
North Shore University Hospital /ID# 224356
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
The Mount Sinai Hospital /ID# 223687
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 224215
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Lenox Hill Hospital /ID# 223534
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Univ NC Chapel Hill /ID# 224405
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514-4220
Country
United States
Facility Name
Wake Forest Baptist Medical Center /ID# 224406
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-0001
Country
United States
Facility Name
Plains Clinical Research Center, LLC /ID# 223522
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104-5925
Country
United States
Facility Name
University of Cincinnati /ID# 224614
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Cleveland Clinic Main Campus /ID# 223691
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
DSI Research, LLC /ID# 234116
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066-1615
Country
United States
Facility Name
Hightower Clinical /ID# 223566
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Digestive Disease Specialists /ID# 223528
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center /ID# 224216
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-2360
Country
United States
Facility Name
Guthrie Medical Group, PC /ID# 223910
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Digestive Disease Associates, LTD /ID# 223462
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610-2002
Country
United States
Facility Name
Medical University of South Carolina /ID# 223485
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Consultants in Gastroenterology - Columbia NE /ID# 224263
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203-8902
Country
United States
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 223497
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Gastro One /ID# 223539
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 224610
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 223512
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
DHAT Research Institute /ID# 223521
City
Garland
State/Province
Texas
ZIP/Postal Code
75044-2208
Country
United States
Facility Name
Vilo Research Group Inc /ID# 223513
City
Houston
State/Province
Texas
ZIP/Postal Code
77017-2337
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center /ID# 223488
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-3411
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC /ID# 223510
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Southern Star Research Institute, LLC /ID# 223598
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Facility Name
Texas Digestive Disease Consultants - Southlake /ID# 224264
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Tyler Research Institute, LLC /ID# 223469
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701-4464
Country
United States
Facility Name
University of Vermont Medical Center /ID# 224047
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-1473
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center /ID# 223586
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 224253
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Harborview Medical Center /ID# 224464
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-2420
Country
United States
Facility Name
West Virginia University Hospitals /ID# 223501
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Hospital Italiano de Buenos Aires /ID# 224550
City
Ciudad Autonoma Buenos Aires
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1199
Country
Argentina
Facility Name
CINME Centro de Investigaciones Metabolicas /ID# 223447
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1027
Country
Argentina
Facility Name
Gedyt /ID# 224698
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1115
Country
Argentina
Facility Name
Hospital Britanico de Buenos Aires /ID# 223432
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Facility Name
Cemic /Id# 223670
City
Ciudad Autonoma de Buenos Aire
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Sanatorio 9 de Julio /ID# 226086
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Hospital Privado Univesitario /ID# 223433
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Wollongong Hospital /ID# 224688
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Mater Misericordiae Limited /ID# 223642
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Griffith University /ID# 223641
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Lyell McEwin Hospital /ID# 223643
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Monash Medical Centre /ID# 224599
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Universitaetsklinikum St. Poelten /ID# 223437
City
Sankt Poelten
State/Province
Niederoesterreich
ZIP/Postal Code
3100
Country
Austria
Facility Name
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 223440
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Medizinische Universitaet Wien /ID# 223438
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 223902
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UCL Saint-Luc /ID# 223900
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU UCL Namur - site Godinne /ID# 223905
City
Godinne
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
UZ Gent /ID# 223899
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven /ID# 223901
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ-Delta /ID# 223896
City
Roeselare
State/Province
West-Vlaanderen
ZIP/Postal Code
8800
Country
Belgium
Facility Name
AZ Maria Middelares /ID# 223908
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU de Liege /ID# 223904
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Groupe Sante CHC - Clinique du MontLegia /ID# 223898
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
ZNA - Jan Palfijn /ID# 223907
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
Facility Name
Vitaz /Id# 224511
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Upeclin Fmb - Unesp /Id# 223234
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Facility Name
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 223233
City
Ribeirão Preto
State/Province
Sao Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Faculdade de Medicina do ABC /ID# 223231
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Kaiser Clinica e Hospital Dia /ID# 223232
City
Sao Jose Do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15015-110
Country
Brazil
Facility Name
UMHAT Kaspela EOOD /ID# 223415
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Second MHAT Sofia /ID# 223425
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda University Hospital EAD /ID# 223757
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Tsaritsa Joanna - ISUL /ID# 223822
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
University of Calgary /ID# 223750
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Allen Whey Khye Lim Professional Corporation /ID# 223755
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 1W2
Country
Canada
Facility Name
Covenant Health /ID# 223753
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6K 4B2
Country
Canada
Facility Name
Fraser Clinical Trials Inc /ID# 223742
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W4
Country
Canada
Facility Name
Percuro Clinical Research, Ltd /ID# 223747
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3M9
Country
Canada
Facility Name
QEII - Health Sciences Centre /ID# 223748
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
London Health Sciences Center- University Hospital /ID# 223741
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Scott Shulman Medicine Professional Corporation /ID# 223754
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Facility Name
Mount Sinai Hospital /ID# 223752
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Axler, Toronto, ON. Canada /ID# 223740
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 0A9
Country
Canada
Facility Name
CISSS de la Monteregie /ID# 224399
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 223744
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
CHUS - Hopital Fleurimont /ID# 224819
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Montreal General Hospital- McGill University Health Center /ID# 223743
City
Montreal
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Sociedad de Servicios Medicos Walsen Galmez /ID# 224032
City
Santiago
State/Province
Region Metropolitana Santiago
ZIP/Postal Code
7500010
Country
Chile
Facility Name
Hospital Guillermo Grant Benavente de Concepción /ID# 223668
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Hospital Las Higueras /ID# 223669
City
Talcahuano
ZIP/Postal Code
1740000
Country
Chile
Facility Name
Anhui Provincial Hospital /ID# 224832
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Peking University Third Hospital /ID# 224479
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Chongqing General Hospital /ID# 232305
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400013
Country
China
Facility Name
Zhongshan Hospital Xiamen University /ID# 224663
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361004
Country
China
Facility Name
Zhujiang Hospital of Southern Medical University /ID# 224524
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
The Sixth Affiliated Hosp Sun /ID# 224416
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Facility Name
The Second Affiliated Hospital of Zhengzhou University /ID# 224528
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 224545
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Tongji Hospital Tongji Medical College of HUST /ID# 224428
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Renmin Hospital of Wuhan University /ID# 224525
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Facility Name
The Third Xiangya Hospital of Central South University /ID# 224754
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Changzhou No.2 People's Hospital /ID# 238965
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213000
Country
China
Facility Name
Nanjing Drum Tower Hospital /ID# 224746
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Wuxi People's Hospital /ID# 224426
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University /ID# 224507
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 224420
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 224786
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 224662
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 224421
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310018
Country
China
Facility Name
The Second Xiangya Hospital of Central South University /ID# 224684
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Shengjing Hospital of China Medical University /ID# 224478
City
Shenyang
ZIP/Postal Code
110022
Country
China
Facility Name
Nemocnice Ceske Budejovice a.s. /ID# 224219
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Hepato-Gastroenterologie HK, s.r.o. /ID# 223277
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Nemocnice Pardubickeho kraje, a.s. /ID# 223256
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Facility Name
Axon Clinical, s.r.o. /ID# 223260
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Nemocnice Horovice - NH Hospital a.s /ID# 223276
City
Praha
ZIP/Postal Code
155 00
Country
Czechia
Facility Name
ISCARE a.s. /ID# 223279
City
Praha
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Chu de Nice-Hopital L'Archet Ii /Id# 223763
City
Nice
State/Province
Alpes-Maritimes
ZIP/Postal Code
06200
Country
France
Facility Name
CHU Clermont-Ferrand /ID# 224529
City
Clermont
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
63100
Country
France
Facility Name
APHM - Hopital Nord /ID# 223869
City
Marseille
State/Province
Bouches-du-Rhone
ZIP/Postal Code
13015
Country
France
Facility Name
CHU Bordeaux - Hopital Haut Leveque /ID# 223764
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 223765
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Montpellier - Hôpital Saint Eloi /ID# 223860
City
Montpellier Cedex 5
State/Province
Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Beaujon /ID# 223863
City
Clichy
State/Province
Ile-de-France
ZIP/Postal Code
92110
Country
France
Facility Name
Centre Médico Chirurgical Ambroise Paré Hartmann /ID# 249859
City
Neuilly Sur Seine
State/Province
Ile-de-France
ZIP/Postal Code
92200
Country
France
Facility Name
CHU de SAINT ETIENNE - Hopital Nord /ID# 223768
City
St. Priest En Jarez
State/Province
Loire
ZIP/Postal Code
42270
Country
France
Facility Name
CHU Reims - Hôpital Robert Debre /ID# 224530
City
Reims CEDEX
State/Province
Marne
ZIP/Postal Code
51092
Country
France
Facility Name
CHRU Nancy - Hopitaux de Brabois /ID# 223767
City
Vandoeuvre-les-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 241098
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
CHU Grenoble - Hopital Michallon /ID# 224091
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Clinique Jules Verne /ID# 223870
City
Nantes
ZIP/Postal Code
44300
Country
France
Facility Name
Polyclinique Grand Sud /ID# 224092
City
Nimes Cedex
ZIP/Postal Code
30932
Country
France
Facility Name
Hopital Universitaire Purpan Hopital Rangueil /ID# 224732
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitaetsklinikum Freiburg /ID# 223406
City
Freiburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Mannheim /ID# 223410
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Ulm /ID# 223400
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Universitaetsklinikum Erlangen /ID# 223404
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinik Regensburg /ID# 223407
City
Ratisbon
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt /ID# 223396
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Praxiszentrum fuer Gastroenterologie /ID# 223409
City
Grevenbroich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41515
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 223482
City
Saarbrücken
State/Province
Saarland
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 223395
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Krankenhaus Waldfriede /ID# 223397
City
Berlin-Zehlendorf
ZIP/Postal Code
14163
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 223405
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis Dr. Michael Mross /ID# 229110
City
Berlin
ZIP/Postal Code
10318
Country
Germany
Facility Name
MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 223411
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
DRK Kliniken Berlin Westend /ID# 223412
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 223403
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus /ID# 223673
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Medizinische Hochschule Hannover /ID# 223402
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
EUGASTRO GmbH /ID# 223401
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Lueneburg /ID# 223408
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Otto-von-Guericke-Universitaet /ID# 223413
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Medizinisches Versorgungszentrum Portal 10 /ID# 224552
City
Muenster
ZIP/Postal Code
48155
Country
Germany
Facility Name
General Hospital of Athens Ippokratio /ID# 223344
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 223342
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 223336
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 223338
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
University General Hospital of Ioannina /ID# 223339
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 223340
City
Pireaus
ZIP/Postal Code
18454
Country
Greece
Facility Name
General Hospital of Thessaloniki Hippokrateio /ID# 223887
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 223774
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 223773
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Clinexpert Kft /ID# 223775
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Semmelweis Egyetem /ID# 223772
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Clinfan Szolgaltato Kft. /ID# 224751
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Soroka University Medical Center /ID# 223556
City
Beer Sheva
State/Province
HaDarom
ZIP/Postal Code
8410101
Country
Israel
Facility Name
The Chaim Sheba Medical Center /ID# 223557
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 223551
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
The Edith Wolfson Medical Center /ID# 227652
City
Holon
ZIP/Postal Code
5822000
Country
Israel
Facility Name
Shaare Zedek Medical Center /ID# 223549
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Rabin Medical Center /ID# 223558
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Assaf Harofeh Medical Center /ID# 224686
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Ospedale Policlinico San Martino /ID# 223329
City
Genoa
State/Province
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 223325
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Agostino Gemelli /ID# 223323
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale San Raffaele IRCCS /ID# 241167
City
Milan
State/Province
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST Rhodense/Presidio Ospedaliero di Rho /ID# 223335
City
Rho
State/Province
Milano
ZIP/Postal Code
20017
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 223332
City
Rome
State/Province
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 223327
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 223330
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera G. Brotzu /ID# 241165
City
Cagliari
ZIP/Postal Code
09121
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 223474
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 223322
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 223324
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 223333
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Kangbuk Samsung Hospital /ID# 223452
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Dong-A University Hospital /ID# 223455
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 223456
City
Daejeon
ZIP/Postal Code
34943
Country
Korea, Republic of
Facility Name
Samsung Medical Center /ID# 223453
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Centro de Investigacion en Artritis y Osteoporosis S.C. /ID# 227179
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Facility Name
BRCR Global México /ID# 223970
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Centro Medico Zambrano Hellion /ID# 224025
City
San Pedro Garza Garcia
State/Province
Nuevo Leon
ZIP/Postal Code
66278
Country
Mexico
Facility Name
Medical Care & Research SA de CV /ID# 223974
City
Mérida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Faicic S de Rl de Cv /Id# 226990
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Radboud Universitair Medisch Centrum /ID# 233750
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Academisch Medisch Centrum /ID# 223228
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Elisabeth Tweesteden Ziekenhuis /ID# 223229
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Universitair Medisch Centrum Utrecht /ID# 223696
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Gastromed Sp. z o.o /ID# 223705
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Malopolskie Centrum Kliniczne /ID# 223708
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-149
Country
Poland
Facility Name
NZOZ Vivamed Jadwiga Miecz /ID# 223706
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Institutul Clinic Fundeni /ID# 223914
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Sana Monitoring /Id# 223682
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
Facility Name
Spitalul Clinic Colentina /ID# 223680
City
Bucuresti
ZIP/Postal Code
020121
Country
Romania
Facility Name
Univ Emergency Hosp Bucharest /ID# 223579
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures /ID# 224017
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Targu Mures Emergency Clinical County Hospital /ID# 223613
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed /ID# 223578
City
Timișoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
Immanuel Kant Baltic Federal University /ID# 224224
City
Kaliningrad
State/Province
Kaliningradskaya Oblast
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 224222
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
City Clinical Hospital No. 31 /ID# 224223
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 223302
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
KM Management, spol. s.r.o. /ID# 223304
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224580
City
Nove Zamky
ZIP/Postal Code
940 34
Country
Slovakia
Facility Name
GASTRO I., s.r.o. /ID# 223303
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Lenasia Clinical Trial Centre /ID# 224306
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Spoke Research Inc /ID# 223803
City
CAPE TOWN Milnerton
State/Province
Western Cape
ZIP/Postal Code
7441
Country
South Africa
Facility Name
Dr MJ Prins /ID# 224304
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Private Practice Dr MN Rajabally /ID# 223805
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7800
Country
South Africa
Facility Name
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 223356
City
Ferrol
State/Province
A Coruna
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 226554
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Central de Asturias /ID# 223368
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol /ID# 223436
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de Bellvitge /ID# 225719
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada /ID# 223371
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 223319
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Universitario de Alicante Doctor Balmis /ID# 223552
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 223355
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 223317
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 223367
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 223318
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena /ID# 223315
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 223476
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia /ID# 223321
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 223314
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Karolinska University Hospital Solna /ID# 223423
City
Solna
State/Province
Stockholms Lan
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
GHP Stockholm Gastro Center /ID# 223420
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
114 28
Country
Sweden
Facility Name
Falu Lasarett /ID# 227222
City
Falun
ZIP/Postal Code
791 31
Country
Sweden
Facility Name
Danderyds sjukhus AB /ID# 223363
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Universitätsspital Basel /ID# 223711
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Universitatsspital Zurich /ID# 223712
City
Zurich
State/Province
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Inselspital, Universitätsspital Bern /ID# 223590
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Gazi Universitesi Tip Fakultes /ID# 223386
City
Yenimahalle
State/Province
Ankara
ZIP/Postal Code
06560
Country
Turkey
Facility Name
Ankara Univ Medical Faculty /ID# 223388
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 223387
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Mersin University Medical /ID# 223385
City
Mersin
ZIP/Postal Code
33343
Country
Turkey
Facility Name
Kyiv Municipal Clinical Hospital #18 /ID# 223700
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital /ID# 223661
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Medical Center of LLC DIASERVIS /ID# 224249
City
Zaporizhzhia
ZIP/Postal Code
69076
Country
Ukraine
Facility Name
University Hospital Southampton NHS Foundation Trust /ID# 224351
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
East and North Hertfordshire NHS Trust /ID# 224607
City
Stevenage
State/Province
Hertfordshire
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Barts Health NHS Trust /ID# 223651
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 2ES
Country
United Kingdom
Facility Name
Guys and St Thomas NHS Foundation Trust /ID# 223647
City
London
State/Province
London, City Of
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust /ID# 224179
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 223645
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde /ID# 223653
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust /ID# 224023
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust /ID# 223648
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
NHS Lothian /ID# 223646
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom
Facility Name
Royal Devon and Exeter NHS Foundation Trust /ID# 223644
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Calderdale and Huddersfield NHS Foundation Trust /ID# 223654
City
Huddersfield
ZIP/Postal Code
HX3 0PW
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 223649
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 223655
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Northern Care Alliance NHS Group /ID# 223650
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
NHS Forth Valley /ID# 224657
City
Stirling
ZIP/Postal Code
FK9 4SW
Country
United Kingdom
Facility Name
St George's University Hospitals NHS Foundation Trust /ID# 223656
City
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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, analyses plans, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/
Description
Related Info

Learn more about this trial

Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)

We'll reach out to this number within 24 hrs