A Long-term Active Treatment Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

NCT02641392 | Terminated Phase 3 Results DMC

• 1 other identifier: GED-0301-CD-004
• Study Type: interventional
• Target: 310
• Locations: 29 countries
• Sites: 221

Brief Summary

The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study. The GED-0301-CD-003 trial was not initiated; see detailed description.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; GED 0301; Mongersen; Safety; Irritable Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208

  A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.

  From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose

Study Arms (5)

GED-0301 (160 mg) followed by Placebo intermittent 160 mg

EXPERIMENTAL

GED-0301 160 mg once daily (QD) for 12 weeks, followed by alternating Placebo (PBO) QD for 4 weeks with GED 0301 160 mg QD for 4 weeks, up to 208 weeks, if the subject previously received Placebo in the prior GED-0301 Study

Drug: GED-0301

Intermittent GED-0301 160 mg and placebo

EXPERIMENTAL

Alternating GED-0301 160 mg once daily (QD) for 4 weeks with placebo (PBO) QD for 4 weeks, up to 208 weeks, depending on previous response in the prior GED-0301 study

Drug: GED-0301; Other: Placebo

Intermittent placebo and GED-0301 40 mg

EXPERIMENTAL

Alternating PBO once daily (QD) for 4 weeks with GED-0301 40 mg QD for 4 weeks with, up to 208 weeks, depending on previous response in the prior GED-0301 study

Drug: GED-0301; Other: Placebo

Continuous GED-0301 40 mg

EXPERIMENTAL

GED-0301 40 mg once daily (QD) for up to 208 weeks

Drug: GED-0301

Intermittent placebo and GED-0301 160 mg

EXPERIMENTAL

Alternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208

Drug: GED-0301; Other: Placebo

Interventions

GED-0301 DRUG

Mongersen

Also known as: Mongersen

Continuous GED-0301 40 mg; GED-0301 (160 mg) followed by Placebo intermittent 160 mg; Intermittent GED-0301 160 mg and placebo; Intermittent placebo and GED-0301 160 mg; Intermittent placebo and GED-0301 40 mg

Placebo OTHER

Placebo

Intermittent GED-0301 160 mg and placebo; Intermittent placebo and GED-0301 160 mg; Intermittent placebo and GED-0301 40 mg

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy the following criteria to be screened and enrolled in the study:
• Male or female ≥ 18 years of age.
• Subject must have participated in the GED-0301-CD-002 or GED 0301 CD 003 study.
• Subject must use protocol approved contraception.
• Adolescent subjects must satisfy the following criteria to be screened and enrolled in the study
• Male or female 12 to 17 years of age.
• Subject must have participated in the GED 0301 CD 003 study.
• Subject is able to swallow the IP tablets.
• Subject must use protocol approved contraception.

You may not qualify if:

• The presence of any of the following will exclude a subject from screening and enrollment:
• Subject had experienced a serious adverse event (SAE) related to the investigational product while participating in the previous Phase 3 GED-0301 study.
• Subject has initiated biologic agents, such as TNF-α blockers or integrin antagonists.
• Subject is pregnant or breastfeeding.
• Subject has developed a known hypersensitivity to oligonucleotides, GED 0301 or any ingredient in the investigational product.

Sponsors & Collaborators

• Celgene: lead

Study Sites (231)

Medical Associates Research Group Inc.

San Diego, California, 902123, United States

Location

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, 30342, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Health Science Research Center, LLC

Pratt, Kansas, 67124, United States

Location

Via Christi Research a division of Via Christi Hospitals Wichita Inc

Wichita, Kansas, 67208, United States

Location

Gastroenterology Associates LLC

Baton Rouge, Louisiana, 70809, United States

Location

Metropolitan Gastroenterology

Chevy Chase, Maryland, 20815, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Gastroenterology Associates of Western Michigan PLC

Wyoming, Michigan, 49519, United States

Location

Ehrhardt Clinical Research LLC

Belton, Missouri, 64012, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Trial Management Associates LLC

Wilmington, North Carolina, 28401, United States

Location

ClinSearch LLC

Chattanooga, Tennessee, 37421, United States

Location

Texas Clinical Research Institute LLC

Arlington, Texas, 76012, United States

Location

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, 75231, United States

Location

Texas Digestive Disease Consultants - Southlake

Flower Mound, Texas, 75028, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Sagact Pllc

San Antonio, Texas, 78229, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78229, United States

Location

Digestive Health Specialists of Tyler

Tyler, Texas, 75701, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington School of Medicine

Seattle, Washington, 98104, United States

Location

The Vancouver Clinic

Vancouver, Washington, 98664-4896, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Centre For Digestive Diseases

Five Dock, New South Wales, 2046, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Mater Adult Hospital

South Brisbane, Queensland, 4101, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Monash Medical Centre Clayton

Bentleigh East, 3165, Australia

Location

LKH Universitaetsklinikum Graz

Graz, 8036, Austria

Location

Medizinische Universitat Innsbruck

Innsbruck, 6020, Austria

Location

KH der Barmherzigen Bruder Linz

Linz, 4021, Austria

Location

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, 5020, Austria

Location

KH der Barmherzigen Brüder St.Veit an der Glan

Sankt Veit an der Glan, 9300, Austria

Location

Krankenanstalt Rudolfstiftung Wien

Wein, 1030, Austria

Location

AKH Medizinische Universitat Wien

Wein, 1090, Austria

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU Sart Tilman

Liège, 4000, Belgium

Location

MHAT Kaspela EOOD

Plovdiv, 4002, Bulgaria

Location

MHAT Ruse AD

Rousse, 7002, Bulgaria

Location

Second MHAT Sofia AD

Sofia, 1202, Bulgaria

Location

City Clinic UMHAC EOOD

Sofia, 1407, Bulgaria

Location

UMHAT Sv Ivan Rilski EAD

Sofia, 1431, Bulgaria

Location

UMHAT Tsaritsa Yoanna - ISUL EAD

Sofia, 1527, Bulgaria

Location

MHAT Doverie AD

Sofia, 1632, Bulgaria

Location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

South Edmonton Gastroenterology

Edmonton, Alberta, T6L 6K3, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

PerCuro Clinical Research

Victoria, British Columbia, V8V 3P9, Canada

Location

Brandon Medical Arts Clinic

Brandon, Manitoba, R7A 0N7, Canada

Location

McMaster University Health Sciences Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

London Health Science Center U. Hospital

London, Ontario, N6A 5A5, Canada

Location

LHSC Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location

Montfort Hospital

Ottawa, Ontario, K1K 0T2, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto Digestive Disease Associates Inc

Vaughan, Ontario, L4L 4Y7, Canada

Location

Medicine Professional Corporation

Waterloo, Ontario, N2J 1C4, Canada

Location

Centre de sante et de services sociaux Champlain Charles Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

McGill University Health Centre Glen Site Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

Location

Fakultni nemocnice u sv Anny v Brne

Brno, 656 91, Czechia

Location

Hepato-Gastroenterologie HK

Hradec Králové, 50012, Czechia

Location

PreventaMed

Olomouc, 77900, Czechia

Location

CCBR Prague CZ

Prague, 13000, Czechia

Location

Aarhus Universitetshospital

Aahus C, 8000, Denmark

Location

Alborg Universitets Hospital

Aalborg, 9000, Denmark

Location

Nordsjaellands Hospital Frederikssund

Frederikssund, 3600, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

Koge Sygehus

Køge, 4600, Denmark

Location

Regionshospitalet Silkeborg

Silkeborg, 8600, Denmark

Location

CHU Amiens Hopital Sud

Amiens, 80054, France

Location

CHU Besancon Hopital Jean Minjoz

Besançon, 25030, France

Location

CHU Tours Hopital Trousseau

Chambray-lès-Tours, 37170, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

CHU Nantes Hotel Dieu

Nantes, 44093, France

Location

CHU Nice Hopital de lArchet 2

Nice, 06200, France

Location

Groupe Hospitalier Sud Hopital Haut Leveque USN

Pessac, 33604, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

CHU Reims Hopital Robert Debre

Reims, 51092, France

Location

CHU Rennes Hopital Pontchaillou

Rennes, 35033, France

Location

CHU Saint Etienne Hopital Nord

Saint-Etienne, 42055, France

Location

CHU Strasbourg Hopital Hautepierre

Strasbourg, 67098, France

Location

CHU de Toulouse Hopital Rangueil

Toulouse, 31059, France

Location

Hopital de Brabois Adultes

Vandœuvre-lès-Nancy, 54511, France

Location

Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

Berlin, 12200, Germany

Location

DRK Kliniken Berlin Westend

Berlin, 14050, Germany

Location

Krankenhaus Waldfriede e V

Berlin, 14163, Germany

Location

Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

Bochum, 44789, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Erlangen

Erlangen, 91054, Germany

Location

Kliniken Essen-Mitte

Essen, 45136, Germany

Location

Agaplesion Markus Krankenhaus

Frankfurt, 60431, Germany

Location

Universitaetsklinikum Halle Saale

Halle, 06120, Germany

Location

Asklepios Klinik Hamburg

Hamburg, 22559, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

Heidelberg, 69121, Germany

Location

Universitaetsklinikum Jena

Jena, 07740, Germany

Location

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105, Germany

Location

University Leipzig

Leipzig, 04103, Germany

Location

EUGASTRO GmbH

Leipzig, 4103, Germany

Location

Medizinisches Zentrum Klinikum Lueneburg

Lüneburg, 21339, Germany

Location

Klinikum Mannheim GmbH Universitaetsklinikum

Mannheim, 68167, Germany

Location

Klinikum der Universitaet Muenchen

München, 81377, Germany

Location

Gastro Campus Research

Münster, 48159, Germany

Location

Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

Niedersachsen, 38126, Germany

Location

Universitaetsklinikum Regensburg

Regensburg, 93053, Germany

Location

Universitaetsklinikum Ulm

Ulm, 89081, Germany

Location

University General Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

Location

General Hospital of Athens Evangelismos

Athens, 10676, Greece

Location

Athens Medical Center

Athens, 15125, Greece

Location

University General Hospital of Patras

Rio Patras, 26500, Greece

Location

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, 8230, Hungary

Location

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, 1062, Hungary

Location

Semmelweis Egyetem AOK

Budapest, 1088, Hungary

Location

Endomedix Diagnosztikai Kozpont

Budapest, 1139, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

Dunaújváros, 2400, Hungary

Location

Petz Aladar Megyei Oktato Korhaz

Győr, 9024, Hungary

Location

Clinfan Szolgaltato Kft

Szekszárd, 7100, Hungary

Location

HaEmek Medical Center

Afula, 18341, Israel

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Hadassah University Hospital

Jerusalem, 9112001, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel Aviv Sourasky Medical Center Department of Hematology

Tel Aviv, 64239, Israel

Location

The Baruch Padeh MC, Poriya

Tiberias, 1520800, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Policlinico G Martino

Messina, 98125, Italy

Location

Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera Vincenzo Cervello

Palermo, 90146, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Universita Campus Bio Medico di Roma

Roma, 00128, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, 00152, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, 133, Italy

Location

Istituto Clinico Humanitas

Rozzano (MI), 20089, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo FG, 71013, Italy

Location

Digestive Diseases Center Gastro

Riga, LV-1006, Latvia

Location

Pauls Stradins Clinical University Hospital

Riga, LV1002, Latvia

Location

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105, Netherlands

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Radboudumc

Nijmegen, 6525 GA, Netherlands

Location

Zuyderland Medisch Centrum

Sittard-Geleen, 6162 BG, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Akershus universitetssykehus HF

Lørenskog, 1478, Norway

Location

Oslo Universitetssykehus Rikshospitalet

Oslo, N-0027, Norway

Location

Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

Kielce, 25-364, Poland

Location

Indywidualna Praktyka Lekarska Maciej Zymla

Knurów, 44-190, Poland

Location

SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow

Lodz, 90-647, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-055, Poland

Location

Endoskopia Sp. z o.o.

Sopot, 81-756, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

Hospital da Senhora da Oliveira Guimaraes

Guimarães, 4835-044, Portugal

Location

S.C MedLife S.A

Bucharest, 010719, Romania

Location

CMI Dr. Tirnaveanu Amelita

Oradea, 410066, Romania

Location

Centrul de Gastroenterologie Dr. Goldis

Timișoara, 300002, Romania

Location

TSBIH Territorial Clinical Hospital

Krasnoyarsk, 660022, Russia

Location

SBHI of NN region RCH of NN n.a. N.A.Semashko

Nizhny Novgorod, 603126, Russia

Location

SBEIHPE Novosibirsk State Medical University

Novosibirsk, 630054, Russia

Location

FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS

Novosibirsk, 630117, Russia

Location

Evromedservis

Pushkin, 196603, Russia

Location

SEIHPE Rostov State Medical University of MoH of RF

Rostov-on-Don, 344022, Russia

Location

SPb SBIH City Hospital # 26

Saint Petersburg, 196247, Russia

Location

NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways

Samara, 443041, Russia

Location

Clinical Center Zvezdara

Belgrade, 11000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Clinical Center Bezanijska Kosa

Belgrade, 11080, Serbia

Location

Fakultna nemocnica s poliklinikou F. D. Roosevelta

Banská Bystrica, 975 17, Slovakia

Location

Alian s.r.o.

Bardejov, 08501, Slovakia

Location

Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.

Malacky, 90122, Slovakia

Location

Fakultna nemocnica Nitra

Nitra, 949 01, Slovakia

Location

KM Management, spol. s r.o.

Nitra, 94901, Slovakia

Location

GASTRO I., s.r.o.

Prešov, 080 01, Slovakia

Location

Dong-A University Hospital

Busan, 49201, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Hanyang University Guri Hospital

Guri-si, 11923, South Korea

Location

CHA Bundang Medical Center CHA University

Seongnam-si, 13496, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Corporacion Sanitaria Parc Tauli

Sabadell, 08208, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Danderyds Sjukhus AB

Stockholm, 18288, Sweden

Location

Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

Bern, 3012, Switzerland

Location

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Yeditepe University Medical School Hospital

Istanbul, 31755, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty Hospital

Istanbul, 34098, Turkey (Türkiye)

Location

Acibadem Fulya Hospital

Istanbul, 34349, Turkey (Türkiye)

Location

Haydarpasa Numune Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Istanbul Medeniyet Uni Goztepe Training&Res Hosp

Istanbul, 34854, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Kocaeli Derince Training and Research Hospital

Kocaeli, 41380, Turkey (Türkiye)

Location

RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

Chernivtsi, 58001, Ukraine

Location

CI of PH Kharkiv CCH #2

Kharkiv, 61037, Ukraine

Location

Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

Kirovohrad, 25006, Ukraine

Location

Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

Kyiv, 01030, Ukraine

Location

Kyiv City Clinical Hospital #1

Kyiv, 02091, Ukraine

Location

SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

Kyiv, 04053, Ukraine

Location

CI Odesa Regional Clinical Hospital

Odesa, 65025, Ukraine

Location

Ternopil City Communal Emergency Medical Care Hospital

Ternopil, 46000, Ukraine

Location

CI Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhya, 69600, Ukraine

Location

Royal Devon and Exeter Hospital Wonford

Exeter, EX2 5DW, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, Scotland, G4 OSF UK, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

Royal London Hospital

London, E1 1BB, United Kingdom

Location

St Marys Hospital

London, W2 1NY, United Kingdom

Location

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Nottingham University Hospitals Queens Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, SY38XQ, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Irritable Bowel Syndrome

Interventions

GED0301

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases

Limitations and Caveats

Following a recommendation by the Data Monitoring Committee (DMC), the study was terminated early by Celgene on 19 Oct 2017 due to a lack of emerging benefit; no emergent safety findings were noted.

Results Point of Contact

• Title: Anne McClain, Senior Manager
• Organization: Celgene Corporation

amcclain@celgene.com

888-260-1599

Study Officials

• Guillermo Rossiter, MD

  Celgene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 29, 2015
• Study Start: July 25, 2016
• Primary Completion: January 4, 2018
• Study Completion: January 4, 2018
• Last Updated: January 29, 2019
• Results First Posted: January 29, 2019

Record last verified: 2019-01

Locations

SE (1); HU (8); LA (2); CZ (4); DE (24); RU (8); CA (16); DK (6); GR (4); ES (5); PT (2); RO (3); US (23); CH (1); NL (6); IL (11); AU (8); PL (5); BE (3); BU (7); IT (12); NO (2); GB (10); TU (9); SL (6); UA (9); CR (1); FR (15); KR (10)