CULTIVATE: A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease
Sponsor
Arena Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04173273
Collaborator
(none)
1,265
358
3
117.6
3.5
0
Study Details
Study Description
Brief Summary
This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the 28-Day Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
This study includes 5 substudies:
Substudy A - Phase 2: A Phase 2, randomized, double-blind, substudy to assess the safety, tolerability, and efficacy of oral etrasimod therapy in participants with moderate to severe CD that supports the selection of an induction and maintenance dose(s) for Phase 3. Substudy A is currently closed for enrollment.
Substudy 1 - Phase 2: A Phase 2b randomized, double-blind, placebo-controlled, dose-ranging induction substudy to evaluate etrasimod as induction therapy and select an induction and maintenance dose(s) for continued evaluation in Phase 3. Substudy 1 is currently enrolling participants.
Substudy 2 - Induction: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as induction therapy.
Substudy 3 - Maintenance: A Phase 3 randomized, double-blind, placebo-controlled substudy to evaluate etrasimod as maintenance therapy. Participants from Substudy 1 and Substudy 2 will be enrolled in Substudy 3.
Substudy 4 - Long-Term Extension: A long-term extension substudy for participants who complete at least 52 weeks of treatment. Participants from Substudy 3 and Substudy A are planned to be enrolled in Substudy 4.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1265 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn's Disease
Actual Study Start Date
:
Feb 12, 2020
Anticipated Primary Completion Date
:
Oct 1, 2023
Anticipated Study Completion Date
:
Dec 1, 2029
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Etrasimod Dose A
|
Drug: Etrasimod
Dose A taken by mouth, once daily.
Other Names:
|
| Experimental: Etrasimod Dose B
|
Drug: Etrasimod
Dose B taken by mouth, once daily.
Other Names:
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Etrasimod matching placebo tablet taken by mouth, once daily.
|
Outcome Measures
Primary Outcome Measures
- Number and Severity of Adverse Events [Substudy A] [Up to approximately 70 weeks]
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
- Proportion of Participants With Endoscopic Response [Substudy 1] [Week 14]
- Proportion of Participants With Endoscopic Response [Substudy 2] [Week 14]
- Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2] [Week 14]
- Proportion of Participants With Clinical Remission CDAI [Substudy 3] [Week 52]
- Proportion of Participants With Endoscopic Response [Substudy 3] [Week 52]
Secondary Outcome Measures
- Proportion of Participants With Endoscopic Response [Substudy A] [Weeks 14 and 66]
- Proportion of Participants With Clinical Remission CDAI [Substudy A] [Up to Week 66]
- Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A] [Baseline to Week 66]
- Change From Baseline in CDAI Score [Substudy A] [Baseline to Week 66]
- Proportion of Participants With Clinical Remission CDAI [Substudy 1] [Week 14]
- Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2] [Week 14]
- Proportion of Participants With Clinical Response CDAI [Substudy 2] [Week 14]
- Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2] [Week 14]
- Proportion of Participants With Endoscopic Remission [Substudy 2] [Week 14]
- Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3] [Week 52]
- Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3] [Week 52]
- Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3] [Week 52]
- Proportion of Participants With Endoscopic Remission [Substudy 3] [Week 52]
- Proportion of Participants With Clinical Remission PRO2 [Substudy 3] [Week 52]
- Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4] [Up to Week 208]
- Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4] [Up to Week 208]
- Number and Severity of Adverse Events [Up to approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4]
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Eligibility criteria applicable to all substudies:
Inclusion Criteria:
-
Men or women 18 to 80 years of age,
-
Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
-
Diagnosed with Crohn's disease (CD) ≥ 3 months
-
Have moderately to severely active CD at Screening
-
Demonstrated inadequate response (ie, primary non-response), loss of response to, or intolerance to ≥ 1 of the following therapies for the treatment of CD:
-
Oral corticosteroids (eg, prednisone or its equivalent, budesonide)
-
Immunosuppressants (eg, azathioprine [AZA], 6 mercaptopurine [6-MP], or methotrexate [MTX])
-
Tumor necrosis factor alpha (TNFα) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
-
Integrin receptor antagonist (eg, vedolizumab)
-
Interleukin -12/-23 antagonist (eg, ustekinumab)
-
Females of childbearing potential must be nonpregnant
-
Females of childbearing potential and males must use contraception
Exclusion Criteria:
-
History of inadequate response (ie, primary non-response) to agents from ≥ 2 classes of biologics marketed for the treatment of CD (ie, TNFα antagonists, interleukin 12/ 23 antagonist, and integrin receptor antagonist).
-
Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening.
-
Have functional or post-operative short-bowel syndrome or any associated complications that may require surgery or interfere with efficacy assessments
-
Had surgical treatment for intra abdominal abscesses ≤ 8 weeks prior to randomization or surgical treatment for perianal abscesses ≤ 4 weeks prior to randomization.
-
Had intestinal resection ≤ 24 weeks prior to randomization or other intra abdominal surgeries ≤ 12 weeks prior to randomization.
-
Have an ileostomy or a colostomy.
Inclusion Criteria for Substudy 3:
- Participants who entered the Extended Induction Period of Substudy 1 and Substudy 2 must have completed the Extended Induction -Week 6 Visit
Inclusion Criteria for Substudy 4:
- Participant must have completed the Week 52 Visit of Substudy 3 or the Week 66 Visit of Substudy A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Digestive Health Specialists | Dothan | Alabama | United States | 36305 |
| 2 | East View Medical Research, LLC | Mobile | Alabama | United States | 36606 |
| 3 | Arizona Digestive Health | Sun City | Arizona | United States | 85351 |
| 4 | Om Research LLC | Apple Valley | California | United States | 92307 |
| 5 | VVCRD Research | Garden Grove | California | United States | 92845 |
| 6 | University of California San Diego Medical Center | La Jolla | California | United States | 92037 |
| 7 | Om Research, LLC | Lancaster | California | United States | 93534 |
| 8 | United Medical Doctors | Los Alamitos | California | United States | 90720 |
| 9 | Entertainment Medical Group, Inc. | Los Angeles | California | United States | 90036 |
| 10 | United Medical Doctors | Murrieta | California | United States | 92563 |
| 11 | San Diego Gastroenterology Medical Associates | San Diego | California | United States | 92103 |
| 12 | ACRC Studies, LLC | San Diego | California | United States | 92119 |
| 13 | Peak Gastroenterology Associates | Colorado Springs | Colorado | United States | 80920 |
| 14 | Xera Med Research | Boca Raton | Florida | United States | 33487 |
| 15 | RecioMed Clinical Research Network, Inc | Boynton Beach | Florida | United States | 33472 |
| 16 | Synergy Healthcare | Bradenton | Florida | United States | 34202 |
| 17 | Gastro Florida | Clearwater | Florida | United States | 33761 |
| 18 | Gastro Florida | Clearwater | Florida | United States | 33762 |
| 19 | Hollywood Research Center | Hollywood | Florida | United States | 33021 |
| 20 | UF Health Jacksonville Gastroenterology-Emerson | Jacksonville | Florida | United States | 32207 |
| 21 | Latashia Hundley, CCRC | Jacksonville | Florida | United States | 32256 |
| 22 | Florida Center for Gastroenterology | Largo | Florida | United States | 33777 |
| 23 | Infinite Clinical Research | Miami | Florida | United States | 33133 |
| 24 | La Salud Research Clinic | Miami | Florida | United States | 33155 |
| 25 | Javier Sobrado, MD | Miami | Florida | United States | 33156 |
| 26 | Anchor Medical Research LLC | Miami | Florida | United States | 33176 |
| 27 | Gastroenterology Group of Naples | Naples | Florida | United States | 34102 |
| 28 | Pharma Research International, Inc. | Naples | Florida | United States | 34110 |
| 29 | Sarkis Clinical Trials | Ocala | Florida | United States | 34474 |
| 30 | Endoscopic Research, Inc. | Orlando | Florida | United States | 32803 |
| 31 | Orlando Health Cancer Institute | Orlando | Florida | United States | 32806 |
| 32 | Pediatric & Adult Research Center | Orlando | Florida | United States | 32825 |
| 33 | IMIC, Inc. | Palmetto Bay | Florida | United States | 33157 |
| 34 | Gastro Florida | Pinellas Park | Florida | United States | 33781 |
| 35 | BRCR Medical Center Inc. | Plantation | Florida | United States | 33322 |
| 36 | Advanced Medical Research Center | Port Orange | Florida | United States | 32127 |
| 37 | Theia Clinical Research, LLC | Saint Petersburg | Florida | United States | 33709 |
| 38 | Advanced Research Institute, Inc. | Saint Petersburg | Florida | United States | 33710 |
| 39 | GCP Clinical Research | Tampa | Florida | United States | 33609 |
| 40 | University of South Florida (USF) | Tampa | Florida | United States | 33612 |
| 41 | Morehouse School of Medicine | Atlanta | Georgia | United States | 30303 |
| 42 | Digestive Healthcare of Georgia | Atlanta | Georgia | United States | 30309 |
| 43 | AGA, LLC | Atlanta | Georgia | United States | 30342 |
| 44 | Atlanta Gastroenterology Associates | Atlanta | Georgia | United States | 30342 |
| 45 | One Health Research Clinic | Norcross | Georgia | United States | 30093 |
| 46 | Illinois Gastroenterology Group - Arlington Heights | Arlington Heights | Illinois | United States | 60005 |
| 47 | Illinois Gastroenterology Group | Gurnee | Illinois | United States | 60031 |
| 48 | CroNOLA, LLC | Houma | Louisiana | United States | 70360 |
| 49 | Gastro Center of Maryland, LLC | Columbia | Maryland | United States | 21045 |
| 50 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 51 | Flint Clinical Research | Flint | Michigan | United States | 48503 |
| 52 | Southern Therapy and Advanced Research, LLC | Jackson | Mississippi | United States | 39216 |
| 53 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 54 | Sierra Clinical Research | Las Vegas | Nevada | United States | 89106 |
| 55 | Allied Health Clinical Research Organization | Freehold | New Jersey | United States | 07728 |
| 56 | NYU Langone IBD Center | New York | New York | United States | 10016 |
| 57 | Carolinas Research Center | Charlotte | North Carolina | United States | 28215 |
| 58 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 59 | Clinical Research of Gastonia | Gastonia | North Carolina | United States | 28054 |
| 60 | Carolina Research | Greenville | North Carolina | United States | 27834 |
| 61 | University of Cincinnati | Cincinnati | Ohio | United States | 45267 |
| 62 | Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | United States | 44060 |
| 63 | Care Access Research | Poland | Ohio | United States | 44514 |
| 64 | Great Lakes Medical Research, LLC | Warren | Ohio | United States | 44483 |
| 65 | Hightower Clinical | Oklahoma City | Oklahoma | United States | 73102 |
| 66 | Digestive Disease Specialists, Inc. | Oklahoma City | Oklahoma | United States | 73112 |
| 67 | Central Sooner Research | Oklahoma City | Oklahoma | United States | 73118 |
| 68 | Penn State Health Milton S.Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
| 69 | Guthrie Clinical Research/Guthrie Foundation | Sayre | Pennsylvania | United States | 18840 |
| 70 | Clinical Research of Rock Hill | Rock Hill | South Carolina | United States | 29732 |
| 71 | Tri-Cities Gastroenterology | Kingsport | Tennessee | United States | 37663 |
| 72 | The University of Texas at Austin Dell Medical School | Austin | Texas | United States | 78712 |
| 73 | Texas Gastroenterology Associates, PA | Cypress | Texas | United States | 77429 |
| 74 | Digestive Health Associates | Houston | Texas | United States | 77024 |
| 75 | Baylor College of Medicine - McNair Campus | Houston | Texas | United States | 77030 |
| 76 | Baylor Gastroenterology Assoc | Houston | Texas | United States | 77030 |
| 77 | The University of Texas Health Science Center at Houston (UTHealth) | Houston | Texas | United States | 77030 |
| 78 | Invesclinic US LLC | McAllen | Texas | United States | 78503 |
| 79 | Linq Research, LLC | Pearland | Texas | United States | 77584 |
| 80 | Spring Gastroenterology | Spring | Texas | United States | 77379 |
| 81 | Tyler Research Institute, LLC | Tyler | Texas | United States | 75701 |
| 82 | Victoria Gastroenterology | Victoria | Texas | United States | 77904 |
| 83 | Care Access Research LLC | Ogden | Utah | United States | 84403 |
| 84 | Blue Ridge Medical Research | Lynchburg | Virginia | United States | 24502 |
| 85 | Swedish Medical Center | Seattle | Washington | United States | 98101 |
| 86 | Marshall University Department of Clinical Research | Huntington | West Virginia | United States | 25701 |
| 87 | Medical College of Wisconsin Clinical Trials Office | Milwaukee | Wisconsin | United States | 53226 |
| 88 | Instituto Medico Elsa Perez (I.M.E.P.) | Ciudadela | Buenos Aires | Argentina | B1702 |
| 89 | Hospital Italiano de La Plata | La Plata | Buenos Aires | Argentina | B1900 |
| 90 | Centro de Investigaciones Médicas Mar del Plata | Mar del Plata | Buenos Aires | Argentina | B7600 |
| 91 | Instituto Medico de la Fundacion Estudios Clinicos | Rosario | Santa Fe | Argentina | S2000 |
| 92 | CEMIC | Buenos Aires | Argentina | 1431 | |
| 93 | Clinica Adventista Belgrano | Ciudad Autonoma Buenos Aires | Argentina | C1430EGF | |
| 94 | Macquarie University Hospital Clinical Trials | Macquarie Park | New South Wales | Australia | 2109 |
| 95 | The Northern Hospital | Epping | Victoria | Australia | 3076 |
| 96 | Footscray Hospital | Footscray | Victoria | Australia | 3011 |
| 97 | Austin Health | Heidelberg | Victoria | Australia | 3084 |
| 98 | The Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 99 | Fiona Stanley Hospital-Harry Perkins Building | Murdoch | Western Australia | Australia | 6150 |
| 100 | LKH Universitäts-Klinikum Graz | Graz | Austria | 8036 | |
| 101 | Medical University Innsbruck, Internal Medicine I | Innsbruck | Austria | 6020 | |
| 102 | AKH Wien- Universitätsklinik für Innere Medizin III Klinische Abteilung für Gastroenterologie & Hepa | Vienna | Austria | 1090 | |
| 103 | Brest Regional Clinical Hospital | Brest | Belarus | 224027 | |
| 104 | Gomel Regional Clinical Hospital | Gomel | Belarus | 246029 | |
| 105 | City Clinical Hospital #10 | Minsk | Belarus | 220096 | |
| 106 | Mogilev Hospital #1 | Mogilev | Belarus | 212018 | |
| 107 | Vitebsk Regional Clinical Hospital | Vitebsk | Belarus | 210037 | |
| 108 | Vitebsk Regional Clinical Specialized Center | Vitebsk | Belarus | 210604 | |
| 109 | AZ Sint-Lucas & Volkskliniek | Gent | Belgium | 9000 | |
| 110 | UZ Gent | Gent | Belgium | 9000 | |
| 111 | AZ Delta tav studies MDL | Roeselare | Belgium | 8800 | |
| 112 | CHU UCL Namur Site Godinne | Yvoir | Belgium | 5530 | |
| 113 | University Clinical Hospital Mostar, Department of gastroenterology | Mostar | Bosnia and Herzegovina | 88000 | |
| 114 | Clinical Center University Sarajevo | Sarajevo | Bosnia and Herzegovina | 71000 | |
| 115 | DCC "Alexandrovska", EOOD | Sofia | Bulgaria | 1431 | |
| 116 | UMHAT 'Tsaritsa Yoanna - ISUL', EAD | Sofia | Bulgaria | 1527 | |
| 117 | UMHATEM 'N.I. Pirogov', EAD | Sofia | Bulgaria | 1606 | |
| 118 | McGill University Health Centre/Glen Site / Royal Victoria Hospital | Montreal | Quebec | Canada | H3G1A4 |
| 119 | Biomedica Research Group | Santiago | Chile | 7500710 | |
| 120 | M y F Estudios Clínicos/MIRES | Santiago | Chile | 7750495 | |
| 121 | CeCim Biocinetic | Santiago | Chile | 8331143 | |
| 122 | Centro de Investigacion del Maule | Talca | Chile | 3465586 | |
| 123 | Clinical Research Chile SpA | Valdivia | Chile | 5090000 | |
| 124 | Clinica de la Costa Ltda. | Barranquilla | Atlantico | Colombia | 080020 |
| 125 | Fundación Cardiomet Cequin | Armenia | Colombia | 630004 | |
| 126 | Clinica de la Mujer S.A.S | Bogota | Colombia | ||
| 127 | Centro de Investigaciones Clínicas S.A.S | Cali | Colombia | 760036 | |
| 128 | General Hospital Koprivnica | Koprivnica | Croatia | 48000 | |
| 129 | General Hospital Zadar | Zadar | Croatia | 23000 | |
| 130 | University hospital centre Zagreb | Zagreb | Croatia | 10000 | |
| 131 | Asclepiades - interna a gastroenterologie s. r. o. | Havirov | Czechia | 736 01 | |
| 132 | Hepato-Gastroenterologie HK, s.r.o. | Hradec Kralove | Czechia | 50012 | |
| 133 | GASTRO JeKa, s.r.o. | Klatovy | Czechia | 33901 | |
| 134 | CTCenter MaVe s.r.o. | Olomouc | Czechia | 77900 | |
| 135 | PreventaMed s.r.o. | Olomouc | Czechia | 77900 | |
| 136 | Axon Clinical s.r.o. | Prague | Czechia | 15000 | |
| 137 | ISCARE a.s. | Prague | Czechia | 19000 | |
| 138 | Nemocnice Slany | Slany | Czechia | 27401 | |
| 139 | Aalborg University Hospital | Aalborg | Denmark | 9000 | |
| 140 | Alexandria Clinical Research Center, Faculty of Medicine, Alexandria University | Alexandria | Egypt | 21131 | |
| 141 | National Hepatology and Tropical Medicine Research Institute | Cairo | Egypt | 11451 | |
| 142 | Cairo University, Kasr Al Aini Hospital | Cairo | Egypt | 11559 | |
| 143 | Ain Shams University Hospital | Cairo | Egypt | 11566 | |
| 144 | Air Force Specialized Hospital (AFSH) | Cairo | Egypt | 11566 | |
| 145 | Theodor Bilharz Research Institute | Giza | Egypt | 12411 | |
| 146 | National Liver Institute | Mansoura | Egypt | 32511 | |
| 147 | Egyptian Liver Research Institute and Hospital (ELRIAH) | Mansoura | Egypt | 35516 | |
| 148 | CHU Nice - Hôpital de l'Archet 2 | Nice Cedex 3 | Alpes Maritimes | France | 06202 |
| 149 | CHU de Reims | Reims | Ardennes | France | 51100 |
| 150 | Chu Besancon | Besançon Cedex | Doubs | France | 25000 |
| 151 | Hopital Rangueil | Toulouse Cedex 09 | Haute Garonne | France | 31059 |
| 152 | Hopital Saint Eloi Pole Digestif Hgea Recherche Clinique Rdc | Montpellier Cedex 5 | Herault | France | 34295 |
| 153 | CHU de Grenoble - Hôpital Nord | Grenoble Cedex 09 | Isere | France | 38043 |
| 154 | CHU Saint Etienne - Hôpital Nord | Saint Etienne | Loire | France | 42055 |
| 155 | Chru Nancy Brabois | Vandoeuvre les Nancy | Meurthe Et Moselle | France | 54511 |
| 156 | Chu Lille | Lille cedex | Nord | France | 59037 |
| 157 | CHU Clermont Ferrand - Hôpital d'Estaing | Clermont Ferrand cedex 1 | Puy De Dome | France | 63000 |
| 158 | Chu Amiens Picardie-Sit Sud | Amiens Cedex | Somme | France | 80054 |
| 159 | Centre Hospitalier Départemental Vendée | La Roche-sur-Yon cedex 9 | Vendee | France | 85925 |
| 160 | LLC Vivamedi | Tbilisi | Georgia | 0131 | |
| 161 | LTD Institute of Clinical Cardiology | Tbilisi | Georgia | 0159 | |
| 162 | JSC Infectious Diseases, AIDS and Clinical Immunology Research Center | Tbilisi | Georgia | 0160 | |
| 163 | LTD Aversi Clinic | Tbilisi | Georgia | 0160 | |
| 164 | LTD Central University Clinic After Academic N. Kipshidze | Tbilisi | Georgia | 0160 | |
| 165 | Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD | Tbilisi | Georgia | 0172 | |
| 166 | Medical Center "CITO" Ltd. | Tbilisi | Georgia | 0179 | |
| 167 | Medius Klinik Nürtingen | Nürtingen | Baden Wuerttemberg | Germany | 72622 |
| 168 | Städtisches Klinikum Brandenburg GmbH | Brandenburg an der Havel | Brandenburg | Germany | 14770 |
| 169 | Agaplesion Markus-Krankenhaus Medizinische Klinik I Studienzentrale | Frankfurt | Hessen | Germany | 60431 |
| 170 | Gastroenterologie Opernstrasse | Kassel | Hessen | Germany | 34117 |
| 171 | Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling | Bonn | Nordrhein Westfalen | Germany | 53123 |
| 172 | Florence Nightingale Krankenhaus | Duesseldorf | Nordrhein Westfalen | Germany | 40489 |
| 173 | Johanna Etienne Krankenhaus | Neuss | Nordrhein Westfalen | Germany | 41462 |
| 174 | Magen-Darm-Zentrum Remscheid | Remscheid | Nordrhein Westfalen | Germany | 42859 |
| 175 | Barebel Renner | Kiel | Schleswig | Germany | 24105 |
| 176 | University General Hospital of Alexandroupoli | Alexandroupolis | Greece | 68100 | |
| 177 | Anticancer-Oncology Hospital of Athens "Agios Savvas" | Athens | Greece | 11522 | |
| 178 | General Hospital of Athens of Chest Diseases Sotiria, C Internal Medicine Clinic | Athens | Greece | 11527 | |
| 179 | General Hospital of Corfu - Agia Eirini | Corfu | Greece | 49100 | |
| 180 | University General Hospital of Heraklion, Gastroenterology Department | Heraklion | Greece | 71110 | |
| 181 | Clinexpert Kft. | Budapest | Hungary | 1033 | |
| 182 | Pannonia Maganorvosi Centrum | Budapest | Hungary | 1136 | |
| 183 | Bugat Pal Korhaz | Gyongyos | Hungary | 3200 | |
| 184 | Szent Borbála Hospital | Tatabanya | Hungary | 2800 | |
| 185 | Krishna Institute of Medical Sciences Limited (KIMS Hospital) | Secunderabad | Andhra Pradesh | India | 500003 |
| 186 | Yashoda Hospital | Secunderabad | Andhra Pradesh | India | 500003 |
| 187 | Maharaja Agrasen Hospital | New Delhi | Delhi | India | 110026 |
| 188 | Surat Institute of Digestive Sciences | Surat | Gujarat | India | 395002 |
| 189 | Gujarat Hospital, Gastro and Vascular Centre | Surat | Gujarat | India | 395009 |
| 190 | Isha Multispeciality Hospital | Vadodara | Gujarat | India | 390007 |
| 191 | Fortis Memorial Research Institute | Gurgaon | Haryana | India | 122002 |
| 192 | Aster DM Healthcare LTD | Kochi | Kerala | India | 682027 |
| 193 | Midas Multispeciality Hospital Pvt. Ltd. | Nagpur | Maharashtra | India | 440010 |
| 194 | S. R. Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | India | 302001 |
| 195 | Portinucula hospital | Galway | Ireland | H53 T971 | |
| 196 | Our Lady of Lourdes Hospital | Louth | Ireland | A92 VW28 | |
| 197 | HaEmek Medical Center | Afula | Israel | 1834111 | |
| 198 | Wolfson Medical Center | Holon | Israel | 5822012 | |
| 199 | Shaare Zedek Medical Center | Jerusalem | Israel | 9103102 | |
| 200 | Galilee Medical Center | Nahariya | Israel | 22100 | |
| 201 | Chaim Sheba Medical Center | Ramat Gan | Israel | 5265602 | |
| 202 | Ziv Medical Center | Safed | Israel | 13100 | |
| 203 | Institute of Gastroenterology and Liver Diseases,Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 6423906 | |
| 204 | I.R.C.C.S Saverio De Bellis, UOC Gastroenterologia II | Castellana Grotte | Bari | Italy | 70013 |
| 205 | IRCCS Ospedale Casa Sollievo della Sofferenza, S.C. Gastroenterologia ed Endoscopia Digestiva | San Giovanni Rotondo | Foggia | Italy | 71013 |
| 206 | U.O.C. Gastroenterologia ed Endoscopia Digestiva | Rho | Milano | Italy | 20017 |
| 207 | Azienda Ospedaliero-Universitaria Sant 'Andrea UOC Malattie dell'a arato di erente | Rome | Roma | Italy | 00189 |
| 208 | IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | Verona | Italy | 37024 |
| 209 | A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente | Catanzaro | Italy | 88100 | |
| 210 | Centro Ricerche Cliniche c/o Policlinico G.B.Rossi, Borgo Roma | Verona | Italy | 37126 | |
| 211 | Ospedale San Bortolo di Vicenza, , Gastroenterologia | Vicenza | Italy | 36100 | |
| 212 | Kojunkai Daido Clinic | Nagoya-shi | Aichi-Ken | Japan | 457-8511 |
| 213 | Tsujinaka Hospital Kashiwanoha | Kashiwa-shi | Chiba-Ken | Japan | 277-0871 |
| 214 | Gifu University Hospital | Gifu-shi | Gifu-Ken | Japan | 501-1194 |
| 215 | Tsuchiura Kyodo General Hospital | Tsuchiura-shi | Ibaraki-Ken | Japan | 300-0028 |
| 216 | Sameshima Hospital | Kagoshima-shi | Kagoshima-Ken | Japan | 892-0846 |
| 217 | Japanese Red Cross Kumamoto Hospital | Kumamoto-shi | Kumamoto-Ken | Japan | 861-8520 |
| 218 | Saga University Hospital | Saga-shi | Saga-Ken | Japan | 849-8501 |
| 219 | JCHO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo-To | Japan | 169-0073 |
| 220 | Korea University Ansan Hospital | Ansan-si | Gyeonggi-do | Korea, Republic of | 15355 |
| 221 | DongGuk University ilsan Hospital | Goyang Si | Gyeonggi-do | Korea, Republic of | 410773 |
| 222 | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13496 |
| 223 | Ajou University Hospital | Suwon | Gyeonggi-do | Korea, Republic of | 16499 |
| 224 | Dong-A University Hospital | Busan | Korea, Republic of | 49201 | |
| 225 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
| 226 | Kyungpook National University Chilgok Hospital | Daegu | Korea, Republic of | 41404 | |
| 227 | Keimyung University Dongsan Hospital | Daegu | Korea, Republic of | 41931 | |
| 228 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 41944 | |
| 229 | The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon | Korea, Republic of | 34943 | |
| 230 | Gachon University Gil Medical Center | Incheon | Korea, Republic of | 21565 | |
| 231 | Kyunghee University Medical Center | Seoul | Korea, Republic of | 02447 | |
| 232 | Inje University Seoul Paik Hospital | Seoul | Korea, Republic of | 04551 | |
| 233 | Gangnam Severance Hospital, Yonsei University Health System | Seoul | Korea, Republic of | 06273 | |
| 234 | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 235 | Chung-Ang University Hospital | Seoul | Korea, Republic of | 06973 | |
| 236 | Kyung Hee University Hospital at Gangdong | Seoul | Korea, Republic of | 134-727 | |
| 237 | P. Stradins Clinical University Hospital | Riga | Latvia | LV-1002 | |
| 238 | Saint George University Hospital Medical Center | Beirut | Lebanon | 11 00 2807 | |
| 239 | Rafik Hariri University Hospital | Beirut | Lebanon | 113-6044 | |
| 240 | Hotel Dieu de France Hospital | Beirut | Lebanon | 166830 | |
| 241 | Hammoud Hospital University Medical Center | Sidon | Lebanon | 652 | |
| 242 | Nini Hospital s.a.l | Tripoli | Lebanon | 1434 | |
| 243 | Vilnius University Hospital Santaros Klinikos | Vilnius | Lithuania | LT-08661 | |
| 244 | Clinical Trial Unit | Kota Bharu | Kelantan | Malaysia | 15200 |
| 245 | Hospital Tengku Ampuan Rahimah Klang | Klang | Selangor | Malaysia | 41200 |
| 246 | University Malaya Medical Centre | Kuala Lumpur | Malaysia | 59100 | |
| 247 | Invesclinic Mx | Irapuato | Guanajuato | Mexico | 36650 |
| 248 | Centro de Investigacion Medico Bilogica y Terapia Avanzada s.c. | Guadalajara | Jalisco | Mexico | 44130 |
| 249 | Servicios Médicos y de Investigación Clínica InspirePharma S de R L de CV. | Monterrey | Nuevo León | Mexico | 64660 |
| 250 | Scientia, Investigacion Clinica S.C. | Chihuahua | Mexico | 31203 | |
| 251 | Faicic S. de R.L. de C.V. | Veracruz | Mexico | 91900 | |
| 252 | PMSI "Timofei Mosneaga" Republican Clinical Hospital | Chisinau | Moldova, Republic of | MD-2025 | |
| 253 | PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery | Chisinau | Moldova, Republic of | MD-2025 | |
| 254 | PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department | Chisinau | Moldova, Republic of | MD-2025 | |
| 255 | PMSI "Sfanta Treime" Municipal Clinical Hospital | Chisinau | Moldova, Republic of | MD-2068 | |
| 256 | Sf. Arhanghel Mihail" Municipal Clinical Hospital | Chisinau | Moldova, Republic of | MD2025 | |
| 257 | Amsterdam UMC, location AMC | Amsterdam | Netherlands | 1105 AZ | |
| 258 | UMC Utrecht, Trialbureau MDL | Utrecht | Netherlands | 3508 GA | |
| 259 | Akershus universitetssykehus, Avdeling for Fordøyelsessykdommer | Nordbyhagen | Norway | 1478 | |
| 260 | The Medical City Clark, Pampanga | Mabalacat | Pampanga | Philippines | 2023 |
| 261 | Makati Medical Center | Manila | Philippines | 1000 | |
| 262 | Philippine General Hospital | Manila | Philippines | 1000 | |
| 263 | The Medical City | Pasig City | Philippines | 1605 | |
| 264 | Beata Wlodarczyk CM Pratia | Czestochowa | Poland | 42-200 | |
| 265 | Karkonoskie Centrum Badan Klinicznych - Lexmedica | Jelenia Gora | Poland | 58-500 | |
| 266 | Specjalistyczne Gabinety Lekarskie LANDA | Krakow | Poland | 31-156 | |
| 267 | Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. jawna | Ksawerow | Poland | 95-054 | |
| 268 | AmiCare Sp. z .o .o. Sp.k. | Lodz | Poland | 90-644 | |
| 269 | IP Clinic | Lodz | Poland | 90-752 | |
| 270 | Allmedica Badania Kliniczne Sp. z o.o. Sp.k. | Nowy Targ | Poland | 34-400 | |
| 271 | Medicome Sp. ZO.O. | Oswiecim | Poland | 32-600 | |
| 272 | Trialmed Crs | Piotrkow Trybunalski | Poland | 97-300 | |
| 273 | Centrum Medyczne Grunwald | Poznan | Poland | 60-369 | |
| 274 | SOLUMED Centrum Medyczne | Poznan | Poland | 60-529 | |
| 275 | Centrum Medyczne Medyk | Rzeszow | Poland | 35-236 | |
| 276 | Korczowski Bartosz, Gabinet Lekarski | Rzeszow | Poland | 35-302 | |
| 277 | Kiepury Clinic | Sosnowiec | Poland | 41-209 | |
| 278 | EZ-MED Centrum Medyczne | Swidnica | Poland | 58-100 | |
| 279 | Centrum Zdrowia MDM | Warszawa | Poland | 00-635 | |
| 280 | Wip Warsaw Ibd Point | Warszawa | Poland | 00-728 | |
| 281 | Body Clinic | Warszawa | Poland | 03-712 | |
| 282 | Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Wroclaw | Poland | 51-162 | |
| 283 | PLANETMED Sp. z o.o. | Wroclaw | Poland | 52-210 | |
| 284 | ETG Zamosc | Zamosc | Poland | 22-400 | |
| 285 | Hospital da Luz Lisboa | Lisboa | Portugal | 1500-650 | |
| 286 | Centro Hospitalar Universitário de São João, EPE | Porto | Portugal | 4200-319 | |
| 287 | Ponce Medical school Foundation, Inc CAIMED Center | Ponce | Puerto Rico | 00716 | |
| 288 | S.C MedLife S.A | Bucuresti | Romania | 010719 | |
| 289 | SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie | Bucuresti | Romania | 012015 | |
| 290 | S.C. Quantum Medical Center S.R.L. Specialitatea Gastroenterologie | Bucuresti | Romania | 012071 | |
| 291 | Delta Health Care SRL | Bucuresti | Romania | 014142 | |
| 292 | S.C Euroclinic Hospital S.A | Bucuresti | Romania | 014461 | |
| 293 | Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie, Sectia Gastroenterologie II | Bucuresti | Romania | 022328 | |
| 294 | Medicina Interna Ii | Bucuresti | Romania | 022328 | |
| 295 | S.C Policlinica CCBR S.R.L | Bucuresti | Romania | 030463 | |
| 296 | Spitalul Clinic Judetean de Urgenta Cluj Napoca | Cluj-Napoca | Romania | 400006 | |
| 297 | Affidea Romania Srl | Constanta | Romania | 900591 | |
| 298 | S.C Pelican Impex S.R.L | Oradea | Romania | 410469 | |
| 299 | S.C. Centrul Medical Unirea S.R.L., Specialitatea Gastroenterologie | Targu Mures | Romania | 540139 | |
| 300 | SAIH "Kemerovo Regional Clinical Hospital" | Kemerovo | Russian Federation | 650066 | |
| 301 | LLC "Medicine Center SibNovoMed | Novosibirsk | Russian Federation | 630005 | |
| 302 | LLC "Novosibirsk GastroCenter" | Novosibirsk | Russian Federation | 630007 | |
| 303 | Llc Ultramed | Omsk | Russian Federation | 644024 | |
| 304 | LLC "Polyclinic of ultrasonography 4D" | Pyatigorsk | Russian Federation | 357502 | |
| 305 | North-Western Medical University n.a. I.I. Mechnikov of Ministry of Healthcare of Russian Federation | Saint Petersburg | Russian Federation | 191015 | |
| 306 | Stavropol Regional Clinical Diagnostic Centre | Stavropol | Russian Federation | 355017 | |
| 307 | Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University | Ufa | Russian Federation | 450077 | |
| 308 | Clinical Center | Belgrade | Serbia | 11000 | |
| 309 | Clinical Health Centre Zvezdara | Belgrade | Serbia | 11000 | |
| 310 | Clinical Hospital Center -Dr Dragisa Misovic-Dedinje | Belgrade | Serbia | 11000 | |
| 311 | General Hospital Euromedik | Belgrade | Serbia | 11000 | |
| 312 | Clinical Center Kragujevac | Kragujevac | Serbia | 34000 | |
| 313 | University Clinical Center Nis | Nis | Serbia | 18000 | |
| 314 | General Hospital Sremska Mitrovica | Sremska Mitrovica | Serbia | 22000 | |
| 315 | Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banska Bystrica | Slovakia | 97517 | |
| 316 | Alian S.R.O | Bardejov | Slovakia | 08501 | |
| 317 | ENDOMED, s.r.o | Kosice | Slovakia | 040 13 | |
| 318 | KM Management spol. s r.o. | Nitra | Slovakia | 94901 | |
| 319 | Gastro LM s.r.o. | Presov | Slovakia | 08001 | |
| 320 | FARMOVS (Pty) Ltd | Bloemfontein | Free State | South Africa | 9301 |
| 321 | JOHESE Clinical Research | Centurion | Gauteng | South Africa | 0157 |
| 322 | Worthwhile Clinical Trials | Johannesburg | Gauteng | South Africa | 1500 |
| 323 | Clinresco Centres | Kempton Park | Gauteng | South Africa | 1619 |
| 324 | Dr Eduan Deetlefs / Spoke Research Inc | Cape Town | Western Cape | South Africa | 7441 |
| 325 | Hospital Marina Baixa | Villajoyosa | Alicante | Spain | 03570 |
| 326 | Hospital Universitari Parc Taulí | Sabadell | Barcelona | Spain | 08208 |
| 327 | Hospital General de Tomelloso | Tomelloso | Ciudad Real | Spain | 13700 |
| 328 | Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | Las Palmas | Spain | 35019 |
| 329 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 330 | Dr. Matthias Froh, Gastroenterologie | Baden | Switzerland | 5404 | |
| 331 | Inselspital, University Hospital for Gastroenterology, Abdominal Center | Bern | Switzerland | 3010 | |
| 332 | Crohn-Colitis Zentrum Bern - Gemeinschaftspraxis Balsiger, Seibold und Partner | Bern | Switzerland | 3012 | |
| 333 | Hacettepe University Medical Faculty | Ankara | Turkey | 06100 | |
| 334 | Gazi Universitesi Tip Fakultesi | Ankara | Turkey | 06500 | |
| 335 | T.C. Saglik Bakanligi Ankara Sehir Hastanesi | Ankara | Turkey | 06800 | |
| 336 | Antalya Training and Research Hospital | Antalya | Turkey | 07100 | |
| 337 | Uludag University Medical Faculty | Bursa | Turkey | 16059 | |
| 338 | Ege Universitesi Tip Fakultesi Hastanesi | Izmir | Turkey | 35100 | |
| 339 | Kocaeli University Research and Training Hospital | Kocaeli | Turkey | 41380 | |
| 340 | Mersin Universitesi Tip Fakultesi | Mersin | Turkey | 33343 | |
| 341 | Karadeniz Tecnical Uni. Med. Fac. | Trabzon | Turkey | 61100 | |
| 342 | Chernivtsi Regional Clinical Hospital | Chernivtsi | Ukraine | 58002 | |
| 343 | I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital | Dnipro | Ukraine | 49005 | |
| 344 | CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC | Kharkiv | Ukraine | 61037 | |
| 345 | CHI Kharkiv City Clinical Hospital #13 | Kharkiv | Ukraine | 61124 | |
| 346 | Medical Center of Limited Liability Company Harmoniia Krasy | Kyiv | Ukraine | 01135 | |
| 347 | Kyiv City Clinical Hospital #1 | Kyiv | Ukraine | 02091 | |
| 348 | Communal Enterprise Volyn Regional Clinical Hospital of Volyn Regional Council | Lutsk | Ukraine | 43005 | |
| 349 | Communal Non-commercial Enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council, D | Lutsk | Ukraine | 43005 | |
| 350 | Communal Noncommercial Enterprise Lviv Clinical Emergency Hospital | Lviv | Ukraine | 21009 | |
| 351 | A. Novak Transcarpathian Regional Clinical Hospital | Uzhgorod | Ukraine | 88018 | |
| 352 | Communal Noncommercial Enterprise Vinnytsia City Clinical Hospital #1, Department of Gastroenterology | Vinnytsia' | Ukraine | 21029 | |
| 353 | MCIC Health Clinic BO LTD TPC Slaomed | Vinnytsia | Ukraine | 21009 | |
| 354 | Vinnytsia M.I.Pyrogov Regional Clinical Hospital of Vinnytsia Regional Council | Vinnytsia | Ukraine | 21018 | |
| 355 | SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU | Vinnytsia | Ukraine | 21029 | |
| 356 | Guy's Hospital | Lambeth | Greater London | United Kingdom | SE1 7EH |
| 357 | Yeovil District Hospital | Yeovil | Somerset | United Kingdom | BA21 4AT |
| 358 | St. James's University Hospital | Leeds | West Yorkshire | United Kingdom | LS9 7TF |
Sponsors and Collaborators
- Arena Pharmaceuticals
Investigators
- Study Director: Arena CT.gov Administrator, Arena Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05033340
Other Study ID Numbers:
- APD334-202
- NCT05033340
First Posted:
Nov 21, 2019
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arena Pharmaceuticals
Additional relevant MeSH terms: