Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
Crohn Disease
About this trial
This is an interventional treatment trial for Crohn Disease focused on measuring Crohn's Disease, GED-0301, Mongersen, IBD, Safety, Efficacy
Eligibility Criteria
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study:
- Male or female ≥ 18 years
- Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period
- Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
- Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
- Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
- Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
- Ileostomy or a colostomy
- Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study.
Sites / Locations
- ADDC Research LLC
- Arizona Digestive Health
- Mayo Clinic Arizona
- Colon & Digestive Health Specialists
- Arizona Digestive Health
- Gastroenterology Associates PA
- HCP Clinical Research LLC
- T. Joseph Raoof MD Inc
- Valley View Internal Medicine
- OM Research
- University of Southern California Medical Center
- Cedars-Sinai Medical Center
- Facey Medical Foundation
- Medical Associates Research Group Inc.
- Clinical Applications Laboratories Inc
- University of California at San Francisco
- Ventura Clinical Trials
- University Of Colorado
- Innovative Clinical Research
- Connecticut Gastroenterology Institute
- Medical Research Center of Connecticut LLC
- Connecticut GI PC Research Division
- Yale University
- Florida Medical Research - Southeastern Integrated Medical
- Sarkis Clinical Trials - Parent
- Borland-Groover Clinic
- Florida Center for Gastroenterology
- Galiz Research LLC
- Advance Medical Research Center
- Cordova Research Institute
- My Community Research Center inc
- Sanitas Research
- Gastroenterology Group of Naples
- GCRM
- Center For Digestive Health
- BRCR Medical Center Inc.
- Advanced Medical Research Center
- East Coast Institute for Research LLC
- Cleveland Clinic Florida Weston
- Shafran Gastroenterology Center
- Atlanta Gastroenterology Associates, LLC
- Georgia Regents University
- Columbus Regional Research Institute
- Atlanta Gastroenterology Specialists PC
- Grand Teton Research Group PLLC
- Northwestern University-Feinberg School of Medicine
- University of Chicago Medical Center
- NorthShore University HealthSystem
- Indiana University
- Iowa Digestive Disease Center
- Health Science Research Center, LLC
- Heartland Research Associates LLC
- Via Christi Research a division of Via Christi Hospitals Wichita Inc
- Graves Gilbert Clinic
- University of Kentucky Medical Center
- University of Louisville
- Gastroenterology Associates LLC
- Clinical Trials of SW Louisiana LLC
- Louisiana Research Center LLC
- University of Maryland Medical Center
- Johns Hopkins University School of Medicine
- Metropolitan Gastroenterology
- Gastro Center of Maryland
- Boston Medical Center
- Commonwealth Clinical Studies PLLC
- UMass Medical Center
- University of Michigan Health System
- Medex Research Institute
- Clinical Research Institute of Michigan, LLC
- Henry Ford Medical Center - New Center One
- Gastroenterology Associates of Western Michigan PLC
- University of Minnesota
- Mayo Clinic
- Ehrhardt Clinical Research LLC
- Jefferson City Medical Group
- Saint Louis University
- Mercy Research
- Mercy Clinic East Communities d/b/a Mercy Health Research
- Dartmouth-Hitchcock Medical Center
- AGA Clinical Research Associates LLC
- Southwest Gastroenterology Associates PC
- Sing Chan Private Practice
- NYU Langone Nassau Gastroenterology Associates
- Montefiore Medical Center PRIME
- The Feinstein Institute for Medical Research PRIME
- Winthrop University Hospital
- North Shore Long Island Jewish Health System
- Concord Medical Group PRIME
- New York University School of Medicine
- New York - Presbyterian/Weill Cornell Medical Center
- Icahn School of Medicine at Mount Sinai
- Columbia University Medical Center
- Premier Medical Group of the Hudson Valley PC
- University of Rochester
- Asheville Gastroenterology Associates, PA
- University of North Carolina at Chapel Hill
- Carolina Center for Liver Disease
- Gaffney Health Services
- Carolinas Medical Center
- PhysiqueMed Clinical Trials
- Kinston Medical Specialists PA
- Clinical Trials of America, LLC
- Trial Management Associates LLC
- PMG Research of Winston-Salem LLC
- Wake Forest University Baptist Medical Center
- Ohio Clinical Research Partners LLC
- Dr. Deepak Sarwal, MD
- UC Health Clinical Trials Office
- Consultants for Clinical Research Inc.
- Cleveland Clinic Foundation
- University Hospitals Case Medical Center
- Clinical Inquest Center Ltd
- Springfield Health Care Center
- Oklahoma University Health Sciences Center
- Oregon Health and Science University
- Main Line Gastroenterology
- Drexel University College of Medicine
- University of Pennsylvania School of Medicine
- Penn State University Milton S Hershey Medical Center
- ClinSearch LLC
- Gastro One
- Vanderbilt University Medical Center
- Texas Clinical Research Institute LLC
- Texas Digestive Disease Consultants - Dallas
- Texas Digestive Disease Consultants Dallas
- Texas Digestive Disease Consultants - Southlake
- Gulf Coast Research Group LLC
- The Methodist Hospital Research Institute
- University of Texas Health Science Center at Houston
- Houston Endoscopy and Research Center
- Sagact Pllc
- San Antonio Military Medical Center
- Scott & White Medical Center
- Digestive Health Specialist of Tyler
- University of Utah
- University of Vermont
- University of Virginia
- Charlottesville Medical Research Center
- Gastroenterology Associates of Tidewater
- Emeritas Research Group
- Digestive and Liver Disease Specialists
- Hunter Holmes Mcguire Ctr
- Virginia Mason Medical Center
- Harborview Medical Center
- Swedish Medical Center
- University of Washington School of Medicine
- The Vancouver Clinic
- Dean Clinic Oregon
- University of Wisconsin Hospital and Clinics
- Medical College of Wisconsin
- Bankstown-Lidcombe Hospital
- Royal Prince Alfred Hospital
- Concord Repatriation General Hospital
- Centre For Digestive Diseases
- Liverpool Hospital
- Mater Adult Hospital
- Princess Alexandra Hospital
- Royal Adelaide Hospital
- Flinders Medical Centre
- Box Hill Hospital
- The Alfred Hospital
- Fiona Stanley Hospital
- Ballarat Base Hospital
- Monash Medical Centre Clayton
- St Vincents Hospital Melbourne
- Austin Hospital
- Royal Brisbane and Women's Hospital
- Nepean Hospital
- LKH Universitaetsklinikum Graz
- Medizinische Universitat Innsbruck
- Klinikum Klagenfurt am Wörtersee
- KH der Barmherzigen Bruder Linz
- a.o.Krankenhaus d.Barmherz.Schwestern Ried
- LKH - Universitätsklinikum der PMU Salzburg
- Ordination Dr. Thomas Haas Darmpraxis Salzburg
- KH der Barmherzigen Brüder St.Veit an der Glan
- Krankenanstalt Rudolfstiftung Wien
- AKH Medizinische Universitat Wien
- Universitair Ziekenhuis Brussel
- Cliniques Universitaires St Luc
- Universitair Ziekenhuis Gent
- UZ Leuven
- CHU Sart Tilman
- Centre Hospitalier de Mouscron
- MHAT Sv Nikolay Chudotvorets EOOD
- MHAT Kaspela EOOD
- MHAT Ruse AD
- Second MHAT Sofia AD
- City Clinic UMHAC EOOD
- UMHAT Sv Ivan Rilski EAD
- UMHAT Tsaritsa Yoanna - ISUL EAD
- Fourth MHAT Sofia EAD
- MHAT Doverie AD
- University of Calgary
- GI Research Institute
- University of Alberta
- South Edmonton Gastroenterology
- Vancouver General Hospital
- GI Research Institute
- PerCuro Clinical Research
- Brandon Medical Arts Clinic
- Barrie GI Associates
- McMaster University Health Sciences Center
- London Health Science Center U. Hospital
- LHSC Victoria Hospital
- Montfort Hospital
- Humber River Hospital
- Mount Sinai Hospital
- Toronto Liver Centre
- Toronto Digestive Disease Associates Inc
- Medicine Professional Corporation
- Tarabain Osman MD
- Centre de sante et de services sociaux Champlain Charles Le Moyne
- Recherche GCP Research
- Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal
- CHUM Hôpital Saint-Luc
- McGill University Health Centre Glen Site Royal Victoria Hospital
- CHUS Hopital Fleurimont
- Recherche Medicale St Jerome Inc
- Royal University Hospital
- Recherche Clinique Sigma Inc
- Clinical Hospital Centre Osijek
- Clinical Hospital Centre Rijeka
- Clinical Hospital Centre Zagreb
- Clinical Hospital Dubrava
- Clinical Hospital Merkur
- Clinical Hospital Sveti Duh
- Fakultni nemocnice u sv Anny v Brne
- Hepato-Gastroenterologie HK
- Soukroma Gastroenterologicka ambulance a endoskopie
- PreventaMed
- CCBR Czech as
- CCBR Prague CZ
- IBD Centrum ISCARE IVF as
- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
- Nemocnice Znojmo
- Aarhus Universitetshospital
- Nordsjaellands Hospital Frederikssund
- Herlev Hospital
- Hvidovre Hospital
- Koge Sygehus
- Regionshospitalet Silkeborg
- Alborg University Hospital
- West Tallinn Central Hospital
- Tartu University Hospital
- Tampereen yliopistollinen sairaala
- Turunmaan sairaala
- CHU Amiens Hopital Sud
- CHU Besancon Hopital Jean Minjoz
- CHU Tours Hopital Trousseau
- CHU Clermont Ferrand
- Hopital Beaujon
- CHU Dijon - Hopital Bocage Central
- CHU de Grenoble Hopital Nord
- Groupement Hospitalier Sud Hopital Bicetre
- Hopital Claude Huriez CHRU Lille
- Hopital Nord
- CHU Nantes Hotel Dieu
- CHU Nice Hopital de lArchet 2
- Hopital Saint Antoine
- Hopital Saint Louis
- Groupe Hospitalier Sud Hopital Haut Leveque USN
- Centre Hospitalier Lyon Sud
- CHU Reims Hopital Robert Debre
- CHU Rennes Hopital Pontchaillou
- CHU de Rouen Hopital Charles Nicolle
- CHU Saint Etienne Hopital Nord
- CHU Strasbourg Hopital Hautepierre
- CHU de Toulouse Hopital Rangueil
- Hopital de Brabois Adultes
- Charite Universitaetsmedizin Berlin Campus Benjamin Franklin
- Charite Campus Virchow Klinikum
- DRK Kliniken Berlin Westend
- Krankenhaus Waldfriede e V
- Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH
- Staedisches Klinikum Brandenburg
- Universitaetsklinikum Carl Gustav Carus TU Dresden
- Zentrum fuer HIV und Hepatogastroenterologie GmbH
- Universitaetsklinikum Erlangen
- Kliniken Essen-Mitte
- Katholische Kliniken Ruhrhalbinsel GmbH
- Agaplesion Markus Krankenhaus
- Crohn Colitis Centrum Rhein Main
- Universitaetsklinikum FreiburgInnere Med.1, Haematologie
- Universitaetsklinikum Halle Saale
- Asklepios Klinik Hamburg
- Medizinische Hochschule Hannover
- Universitatsklinikum Heidelberg
- Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter
- Universitaetsklinikum Jena
- Universitaetsklinikum Schleswig Holstein Campus Kiel
- University Leipzig
- Internistische Gemeinschaftspraxis f. Verdauungs- und Stoffwechselerkrankungen
- EUGASTRO GmbH
- Medizinisches Zentrum Klinikum Lueneburg
- Universitaetsklinikum Magdeburg A oeR
- Klinikum Mannheim GmbH Universitaetsklinikum
- Gastroenterologische Praxis Minden
- Isar Klinik GmbH
- Universitaetsklinikum Muenster
- Gastro Campus Research
- Klinikum der Universitaet Muenchen
- Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer
- Universitaetsklinikum Regensburg
- Universitaetsklinikum Ulm
- University General Hospital of Alexandroupolis
- General Hospital of Athens Evangelismos
- Athens Medical Center
- General Hospital of Nikaea Piraeus Ag. Panteleimon
- University General Hospital of Heraklion
- General Hospital of Heraklion Benizeleio Pananeio
- University General Hospital of Ioannina
- University General Hospital of Patras
- Anticancer Hospital of Thessaloniki THEAGENIO
- General Hospital of Thessaloniki Hippokration
- DRC Gyogyszervizsgalo Kozpont Kft
- Clinexpert Egeszsegugyi Szolg es Ker Kft
- Magyar Honvedseg Egeszsegugyi Kozpont
- Semmelweis Egyetem AOK
- Semmelweis Egyetem AOK
- Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
- Pannonia Maganorvosi Centrum
- Endomedix Diagnosztikai Kozpont
- Debreceni Egyetem Klinikai Kozpont
- Szent Pantaleon Korhaz Rendelointezet Dunaujvaros
- Markhot Ferenc Oktato Korhaz es Rendelointezet
- Petz Aladar Megyei Oktato Korhaz
- Bekes Megyei Pandy Kalman Korhaz
- Somogy Megyei Kaposi Mor Oktato Korhaz
- Mohacsi Korhaz
- SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
- Mazso-Pharma Kutatas-fejlesztesi Kft
- Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
- Clinfan Szolgaltato Kft
- HaEmek Medical Center
- Soroka University Medical Center
- Rambam Health Care Campus
- Wolfson Medical Center
- Shaare Zedek Medical Center
- Hadassah University Hospital
- Rabin Medical Center
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center Department of Hematology
- Assaf Harofeh Medical Center
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
- Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi
- Azienda Ospedaliera Universitaria Policlinico G Martino
- Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
- Seconda Universita Degli Studi Di Napoli
- Azienda Ospedaliera Universitaria Federico II
- Hospital of Di Padova
- Azienda Ospedaliera Vincenzo Cervello
- Fondazione IRCCS Policlinico San Matteo
- Azienda Ospedaliero Universitaria Pisana
- Universita Campus Bio-Medico di Roma
- Ospedale Sandro Pertini
- Complesso Integrato Columbus
- Policlinico Universitario Agostino Gemelli
- Azienda Ospedaliera San Camillo Forlanini
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Istituto Clinico Humanitas
- Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi dAragona
- IRCCS Policlinico San Donato
- IRCCS Ospedale Casa Sollievo della Sofferenza
- Dong-A University Hospital
- Pusan National University Hospital
- Yeungnam University Medical Center
- Hanyang Univerisy Guri Hospital
- CHA Bundang Medical Center CHA University
- Seoul National University Bundang Hospital
- Kyung Hee University Hospital
- Kangbuk Samsung Hospital
- Asan Medical Center
- Severance Hospital, Yonsei University Health System
- Samsung Medical Center
- Korea University Anam Hospital
- Ewha Womans University Mokdong Hospital
- The Catholic University of Korea, St.Vicent's Hospital
- Digestive Diseases Center Gastro
- Riga East Clinical University Hospital clinic Gailezers
- Pauls Stradins Clinical University Hospital
- Hospital Sultanah Bahiyah
- Hospital Raja Perempuan Zainab II
- Hospital Ampang
- University Malaya Medical Centre
- Hospital Universiti Sains Malaysia
- VU Medisch Centrum
- Academisch Medisch Centrum
- Amphia Ziekenhuis
- Universitair Medisch Centrum Groningen
- Leiden Universitair Medisch Centrum
- Medisch Centrum Haaglanden,Antoniushoeve
- Radboudumc
- Zuyderland Medisch Centrum
- St. Elisabeth Ziekenhuis
- University Medical Center Utrecht
- Waikato Hospital
- Sykehuset Ostfold Fredrikstad
- Akershus universitetssykehus HF
- Oslo Universitetssykehus HF Ulleval
- Oslo Universitetssykehus Rikshospitalet
- Stavanger Unviversitetssjukehus Helse Stavanger HF
- SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego
- Clinsante S.C. Osrodek Badan Klinicznych
- Uniwersyteckie Centrum Kliniczne
- Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA
- Indywidualna Praktyka Lekarska Maciej Zymla
- Centrum Medyczne Plejady
- LUX MED Sp. z o.o.
- SPZOZ Szpital Uniwersytecki w Krakowie
- SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow
- Centrum Medyczne AMED
- GASTROMED Sp.zo.o.
- Ai Centrum Medyczne Sp. Z O.O. Sp.K.
- Centrum Medyczne Medyk
- Endoskopia Sp. z o.o.
- Nzoz Vivamed
- LexMedica Osrodek Badan Klinicznych
- Hospital de Braga
- Centro Hospitalar E Universitario de Coimbra EPE
- Hospital da Senhora da Oliveira Guimaraes
- Hospital Da Luz
- Centro Hospitalar de Sao Joao, EPE
- Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE
- S.C MedLife S.A
- Tvm Med Serv Srl
- Spitalul Clinic Judetean de Urgente Sf. Spiridon
- CMI Dr. Tirnaveanu Amelita
- Centrul de Gastroenterologie Dr. Goldis
- Irkutsk State Medical Academy of Continuing Education
- TSBIH Territorial Clinical Hospital
- Medical Center Stolitsa-Medikl
- SBHI of NN region RCH of NN n.a. N.A.Semashko
- SBEIHPE Novosibirsk State Medical University
- RSHI State Novosibirsk Regional Clinical Hospital
- FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS
- BHI of Omsk region Clinical Oncology Dispensary
- SBEI of HPE Omsk State Medical Academy Ministry of healthcare of RF
- SBIH of Perm territory City Clinical Hospital 2 na Fedor Khristoforovich Gral
- Evromedservis
- SEIHPE Rostov State Medical University of MoH of RF
- City Mariinskaya Hospital
- SPb SBIH City Hospital # 26
- Private Educational Institution of Higher Education Medical university REAVIZ
- NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways
- SHI Regional Clinical Hospital
- SBI of Healthcare of Leningrad region Clinical Interregional Hospital of Tosno
- SBHI of Yaroslavl Region Clinical Hospital 8
- Clinical Center of Serbia
- Clinical Center Zvezdara
- Military Medical Academy
- Clinical Center Bezanijska Kosa
- Clinical Center Zemun
- Clinical Center Kragujevac
- Clinical Center Nis
- Fakultna nemocnica s poliklinikou F. D. Roosevelta
- Alian s.r.o.
- Univerzitna nemocnica Bratislava Nemocnica Ruzinov
- Gastroentero-Hepatologicke centrum THALION
- Nemocnica A.Lena Humenne n o
- B & B MED, s.r.o.
- KARDIO 1 s.r.o.
- Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.
- Fakultna nemocnica Nitra
- KM Management, spol. s r.o.
- GASTRO I., s.r.o.
- Nemocnica s poliklinikou sv Barbory Roznava a s
- Fakultna nemocnica s poliklinikou Zilina
- Hospital Universitari Germans Trias i Pujol
- Hospital del Mar
- Hospital Clinic I Provincial de Barcelona
- Hospital Universitario Reina Sofia
- Hospital Universitario de la Princesa
- Hospital Universitario Ramon y Cajal
- Hospital Universitario Puerta de Hierro Majadahonda
- Corporacion Sanitaria Parc Tauli
- Hospital Universitario Infanta Sofia
- Hospital Universitario Virgen Del Rocio
- Hospital Universitario Virgen Macarena
- Hospital Universitario Miguel Servet
- Sodersjukhuset
- Danderyds Sjukhus AB
- Akademiska Sjukhuset
- Universitaetsspital Basel
- Inselspital - Universitaetsspital Bern
- Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner
- Kantonsspital St.Gallen
- Universitaetsspital Zuerich
- Ankara University Medical Faculty
- Hacettepe University Medical Faculty
- Turkiye Yuksek Ihtisas Hospital
- Gazi University Medical Faculty
- Firat University Medical Faculty
- Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
- Yeditepe University Medical School Hospital
- Istanbul University Cerrahpasa Medical Faculty Hospital
- Acibadem Fulya Hospital
- Haydarpasa Numune Training and Research Hospital
- Istanbul Medeniyet Uni Goztepe Training&Res Hosp
- Marmara University Pendik Training and Research Hospital
- Ege University Medical Faculty
- Inonu Uni. Med. Fac.
- Mersin University Medical Faculty
- Kocaeli Derince Training and Research Hospital
- RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU
- CI of PH Kharkiv CCH #2
- GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
- Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus
- Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC
- Kyiv City Clinical Hospital #1
- SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU
- Lviv Regional Clinical Hospital D Halytskyi Lviv NMU
- Lviv Municipal City Clinical Hospital #5 Dept of Therapy D.Halytsky Lviv NMU
- CI Odesa Regional Clinical Hospital
- Communal Institution City Policlinic #20 Cabinet of Gastroenterology
- M.V. Sklifosovskyi Poltava RCH Outpatient UMSA HSEIU Ukrainian Medical Stomatological Academy
- CI of SRC Sumy RCH Dept of Rheumatology Sumy SU MI
- Ternopil City Communal Emergency Medical Care Hospital
- M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU
- SRI of Invalid Rehabilitation EST Complex of Vinnytsia M.I.Pyrogov NMU MOHU
- SI Branch CH of Zaporizhzhia Station-2 of SE Prydniprovska Railway Dept of Surgery Zaporizhzhia SMU
- CI Zaporizhzhia Regional Clinical Hospital of ZRC
- Queen Elizabeth Hospital
- Bristol Royal Infirmary
- Royal Devon and Exeter Hospital Wonford
- Glasgow Royal Infirmary
- Queen Elizabeth University Hospital
- Hull Royal Infirmary
- Royal London Hospital
- St Marys Hospital
- Manchester Royal Infirmary
- University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung
- Nottingham University Hospitals Queens Medical Centre
- John Radcliffe Hospital
- Borders General Hospital
- Royal Shrewsbury Hospital
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301
GED0301 160mg x 12 weeks followed by periodic GED0301 40mg
GED0301 160mg x 12 weeks followed by continuous GED0301 40mg
Placebo
GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 160 mg QD for 4 weeks and placebo QD for 4 weeks, until the the Week 52 Visit
GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 40 mg QD for 4 weeks and placebo QD for 4 weeks, until the Week 52 Visit
GED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit
Placebo once daily (QD) until the Week 52 Visit