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AzTrials

Crohn's DiseasePhase 3NCT02641392

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

A Phase 3 study testing GED-0301 in people with Crohn's Disease, run by Celgene at 231 sites in 31 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
GED-0301
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
231 sitesin 31 countries
Study dates
25 Jul 2016to 4 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

231 sites in 31 countries.

231 sites in 31 countries

Germany24 sites

  • Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12200

  • DRK Kliniken Berlin Westend

    Berlin, 14050

  • Krankenhaus Waldfriede e V

    Berlin, 14163

  • Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

    Bochum, 44789

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Kliniken Essen-Mitte

    Essen, 45136

  • Agaplesion Markus Krankenhaus

    Frankfurt, 60431

  • Universitaetsklinikum Halle Saale

    Halle, 06120

  • Asklepios Klinik Hamburg

    Hamburg, 22559

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

    Heidelberg, 69121

  • Universitaetsklinikum Jena

    Jena, 07740

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, 24105

  • University Leipzig

    Leipzig, 04103

  • EUGASTRO GmbH

    Leipzig, 4103

  • Medizinisches Zentrum Klinikum Lueneburg

    Lüneburg, 21339

  • Klinikum Mannheim GmbH Universitaetsklinikum

    Mannheim, 68167

  • Klinikum der Universitaet Muenchen

    München, 81377

  • Gastro Campus Research

    Münster, 48159

  • Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

    Niedersachsen, 38126

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

United States23 sites

  • Texas Clinical Research Institute LLC

    Arlington, Texas, 76012

  • Atlanta Gastroenterology Associates, LLC

    Atlanta, Georgia, 30342

  • Gastroenterology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Ehrhardt Clinical Research LLC

    Belton, Missouri, 64012

  • ClinSearch LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Metropolitan Gastroenterology

    Chevy Chase, Maryland, 20815

  • Texas Digestive Disease Consultants - Dallas

    Dallas, Texas, 75231

  • Texas Digestive Disease Consultants - Southlake

    Flower Mound, Texas, 75028

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • Columbia University Medical Center

    New York, New York, 10032

  • Health Science Research Center, LLC

    Pratt, Kansas, 67124

  • Sagact Pllc

    San Antonio, Texas, 78229

  • San Antonio Military Medical Center

    San Antonio, Texas, 78229

  • Medical Associates Research Group Inc.

    San Diego, California, 902123

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Washington School of Medicine

    Seattle, Washington, 98104

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • The Vancouver Clinic

    Vancouver, Washington, 98664-4896

  • Via Christi Research a division of Via Christi Hospitals Wichita Inc

    Wichita, Kansas, 67208

  • Trial Management Associates LLC

    Wilmington, North Carolina, 28401

  • Gastroenterology Associates of Western Michigan PLC

    Wyoming, Michigan, 49519

Other trials in United States

Canada16 sites

  • Brandon Medical Arts Clinic

    Brandon, Manitoba, R7A 0N7

  • University of Calgary

    Calgary, Alberta, T2N 1N4

  • University of Alberta

    Edmonton, Alberta, T6G 2X8

  • South Edmonton Gastroenterology

    Edmonton, Alberta, T6L 6K3

  • Centre de sante et de services sociaux Champlain Charles Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • McMaster University Health Sciences Center

    Hamilton, Ontario, L8N 3Z5

  • London Health Science Center U. Hospital

    London, Ontario, N6A 5A5

  • LHSC Victoria Hospital

    London, Ontario, N6A 5W9

  • McGill University Health Centre Glen Site Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • Montfort Hospital

    Ottawa, Ontario, K1K 0T2

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Associates Inc

    Vaughan, Ontario, L4L 4Y7

  • PerCuro Clinical Research

    Victoria, British Columbia, V8V 3P9

  • Medicine Professional Corporation

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

France15 sites

  • CHU Amiens Hopital Sud

    Amiens, 80054

  • CHU Besancon Hopital Jean Minjoz

    Besançon, 25030

  • CHU Tours Hopital Trousseau

    Chambray-lès-Tours, 37170

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000

  • Hopital Beaujon

    Clichy, 92110

  • CHU Nantes Hotel Dieu

    Nantes, 44093

  • CHU Nice Hopital de lArchet 2

    Nice, 06200

  • Groupe Hospitalier Sud Hopital Haut Leveque USN

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Reims Hopital Robert Debre

    Reims, 51092

  • CHU Rennes Hopital Pontchaillou

    Rennes, 35033

  • CHU Saint Etienne Hopital Nord

    Saint-Etienne, 42055

  • CHU Strasbourg Hopital Hautepierre

    Strasbourg, 67098

  • CHU de Toulouse Hopital Rangueil

    Toulouse, 31059

  • Hopital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy12 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Policlinico G Martino

    Messina, 98125

  • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, 90146

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Universita Campus Bio Medico di Roma

    Roma, 00128

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, 00152

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, 133

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo FG, 71013

Other trials in Italy

Israel11 sites

  • HaEmek Medical Center

    Afula, 18341

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah University Hospital

    Jerusalem, 9112001

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center Department of Hematology

    Tel Aviv, 64239

  • The Baruch Padeh MC, Poriya

    Tiberias, 1520800

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

South Korea10 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Yeungnam University Medical Center

    Daegu, 42415

  • Hanyang University Guri Hospital

    Guri-si, 11923

  • CHA Bundang Medical Center CHA University

    Seongnam-si, 13496

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kyung Hee University Hospital

    Seoul, 02447

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

United Kingdom10 sites

  • Royal Devon and Exeter Hospital Wonford

    Exeter, EX2 5DW

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Glasgow Royal Infirmary

    Glasgow, Scotland, G4 OSF UK

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Royal London Hospital

    London, E1 1BB

  • St Marys Hospital

    London, W2 1NY

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Nottingham University Hospitals Queens Medical Centre

    Nottingham, NG7 2UH

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • Royal Shrewsbury Hospital

    Shrewsbury, SY38XQ

Other trials in United Kingdom

Turkey (Türkiye)9 sites

  • Ankara University Medical Faculty

    Ankara, 06100

  • Yeditepe University Medical School Hospital

    Istanbul, 31755

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Istanbul, 34098

  • Acibadem Fulya Hospital

    Istanbul, 34349

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 34668

  • Istanbul Medeniyet Uni Goztepe Training&Res Hosp

    Istanbul, 34854

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34899

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli Derince Training and Research Hospital

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Ukraine9 sites

  • RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

    Chernivtsi, 58001

  • CI of PH Kharkiv CCH #2

    Kharkiv, 61037

  • Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

    Kirovohrad, 25006

  • Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

    Kyiv, 01030

  • Kyiv City Clinical Hospital #1

    Kyiv, 02091

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

    Kyiv, 04053

  • CI Odesa Regional Clinical Hospital

    Odesa, 65025

  • Ternopil City Communal Emergency Medical Care Hospital

    Ternopil, 46000

  • CI Zaporizhzhia Regional Clinical Hospital of ZRC

    Zaporizhzhya, 69600

Other trials in Ukraine

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre Clayton

    Bentleigh East, 3165

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Centre For Digestive Diseases

    Five Dock, New South Wales, 2046

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

Other trials in Australia

Hungary8 sites

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, 8230

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis Egyetem AOK

    Budapest, 1088

  • Endomedix Diagnosztikai Kozpont

    Budapest, 1139

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

    Dunaújváros, 2400

  • Petz Aladar Megyei Oktato Korhaz

    Győr, 9024

  • Clinfan Szolgaltato Kft

    Szekszárd, 7100

Other trials in Hungary

Russia8 sites

  • TSBIH Territorial Clinical Hospital

    Krasnoyarsk, 660022

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

    Nizhny Novgorod, 603126

  • SBEIHPE Novosibirsk State Medical University

    Novosibirsk, 630054

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

    Novosibirsk, 630117

  • Evromedservis

    Pushkin, 196603

  • SEIHPE Rostov State Medical University of MoH of RF

    Rostov-on-Don, 344022

  • SPb SBIH City Hospital # 26

    Saint Petersburg, 196247

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

    Samara, 443041

Other trials in Russia

Austria7 sites

  • LKH Universitaetsklinikum Graz

    Graz, 8036

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

  • KH der Barmherzigen Bruder Linz

    Linz, 4021

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • KH der Barmherzigen Brüder St.Veit an der Glan

    Sankt Veit an der Glan, 9300

  • Krankenanstalt Rudolfstiftung Wien

    Wein, 1030

  • AKH Medizinische Universitat Wien

    Wein, 1090

Other trials in Austria

Bulgaria7 sites

  • MHAT Kaspela EOOD

    Plovdiv, 4002

  • MHAT Ruse AD

    Rousse, 7002

  • Second MHAT Sofia AD

    Sofia, 1202

  • City Clinic UMHAC EOOD

    Sofia, 1407

  • UMHAT Sv Ivan Rilski EAD

    Sofia, 1431

  • UMHAT Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • MHAT Doverie AD

    Sofia, 1632

Other trials in Bulgaria

Denmark6 sites

  • Aarhus Universitetshospital

    Aahus C, 8000

  • Alborg Universitets Hospital

    Aalborg, 9000

  • Nordsjaellands Hospital Frederikssund

    Frederikssund, 3600

  • Herlev Hospital

    Herlev, 2730

  • Koge Sygehus

    Køge, 4600

  • Regionshospitalet Silkeborg

    Silkeborg, 8600

Other trials in Denmark

Netherlands6 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Academisch Medisch Centrum

    Amsterdam, 1105

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • Radboudumc

    Nijmegen, 6525 GA

  • Zuyderland Medisch Centrum

    Sittard-Geleen, 6162 BG

  • St. Elisabeth Ziekenhuis

    Tilburg, 5022 GC

Other trials in Netherlands

Slovakia6 sites

  • Fakultna nemocnica s poliklinikou F. D. Roosevelta

    Banská Bystrica, 975 17

  • Alian s.r.o.

    Bardejov, 08501

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

    Malacky, 90122

  • Fakultna nemocnica Nitra

    Nitra, 949 01

  • KM Management, spol. s r.o.

    Nitra, 94901

  • GASTRO I., s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Poland5 sites

  • Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

    Kielce, 25-364

  • Indywidualna Praktyka Lekarska Maciej Zymla

    Knurów, 44-190

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

    Lodz, 90-647

  • Centrum Medyczne Medyk

    Rzeszów, 35-055

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

Other trials in Poland

Spain5 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Corporacion Sanitaria Parc Tauli

    Sabadell, 08208

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Czechia4 sites

  • Fakultni nemocnice u sv Anny v Brne

    Brno, 656 91

  • Hepato-Gastroenterologie HK

    Hradec Králové, 50012

  • PreventaMed

    Olomouc, 77900

  • CCBR Prague CZ

    Prague, 13000

Other trials in Czechia

Greece4 sites

  • University General Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • General Hospital of Athens Evangelismos

    Athens, 10676

  • Athens Medical Center

    Athens, 15125

  • University General Hospital of Patras

    Rio Patras, 26500

Other trials in Greece

Belgium3 sites

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • UZ Leuven

    Leuven, 3000

  • CHU Sart Tilman

    Liège, 4000

Other trials in Belgium

Romania3 sites

  • S.C MedLife S.A

    Bucharest, 010719

  • CMI Dr. Tirnaveanu Amelita

    Oradea, 410066

  • Centrul de Gastroenterologie Dr. Goldis

    Timișoara, 300002

Other trials in Romania

Serbia3 sites

  • Clinical Center Zvezdara

    Belgrade, 11000

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Center Bezanijska Kosa

    Belgrade, 11080

Other trials in Serbia

Latvia2 sites

  • Digestive Diseases Center Gastro

    Riga, LV-1006

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

Norway2 sites

  • Akershus universitetssykehus HF

    Lørenskog, 1478

  • Oslo Universitetssykehus Rikshospitalet

    Oslo, N-0027

Other trials in Norway

Portugal2 sites

  • Hospital de Braga

    Braga, 4710-243

  • Hospital da Senhora da Oliveira Guimaraes

    Guimarães, 4835-044

Other trials in Portugal

Croatia1 site

  • Clinical Hospital Centre Osijek

    Osijek, 31000

Other trials in Croatia

Sweden1 site

  • Danderyds Sjukhus AB

    Stockholm, 18288

Other trials in Sweden

Switzerland1 site

  • Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

    Bern, 3012

Other trials in Switzerland

About this study

Official title: A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

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.

Read the detailed description

This is a long-term active treatment study in patients with Crohn's disease (CD). Subjects who met the early escape criteria in Study GED-0301-CD-002, or subjects who completed Study GED-0301-002 or GED-0301-003, may be eligible for this study. Primary objective is to assess long-term safety of GED 0301. Additional efficacy and patient reported outcomes will be explored.

There are 5 possible treatment groups for GED-0301-CD-002 Subjects (Groups 1-5). There are 3 possible treatment groups for GED-0301-CD-003 subjects (Groups 1-3). Treatment is assigned based on clinical improvement achieved or not achieved from the core GED-0301 study.

  1. continuous GED-0301 160 mg once daily for 12 weeks, followed by alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
  2. alternating GED-0301 160 mg once daily for 4 weeks with placebo once daily for 4 weeks, through Week 208;
  3. alternating placebo once daily for 4 weeks with GED-0301 160 mg once daily for 4 weeks, through Week 208;
  4. continuous GED-0301 40 mg once daily through Week 208;
  5. alternating placebo once daily for 4 weeks, followed by GED-0301 40 mg once daily for 4 weeks, through Week 208.

The GED-0301-CD-003 trial was not initiated; the GED-0301 program was terminated; no safety findings were noted.

Conditions
Crohn's Disease
Being tested
GED-0301, Placebo
Keywords
Crohn's Disease, GED 0301, Mongersen, Safety, Irritable Bowel Disease
Medical subject headings
Crohn Disease, Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GED-0301Drug

    Also called Mongersen

    Mongersen

  • PlaceboOther

    Placebo

Study groups in NCT02641392
Study groupRoleWhat they receive
GED-0301 (160 mg) followed by Placebo intermittent 160 mgExperimentalGED-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
Receives: Drug: GED-0301
Intermittent GED-0301 160 mg and placeboExperimentalAlternating 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
Receives: Drug: GED-0301; Other: Placebo
Intermittent placebo and GED-0301 40 mgExperimentalAlternating 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
Receives: Drug: GED-0301; Other: Placebo
Continuous GED-0301 40 mgExperimentalGED-0301 40 mg once daily (QD) for up to 208 weeks
Receives: Drug: GED-0301
Intermittent placebo and GED-0301 160 mgExperimentalAlternating PBO QD for 4 weeks with GED-0301 160 mg QD for 4 weeks, through Week 208
Receives: Drug: GED-0301; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study start25 Jul 2016
  3. Primary completion4 Jan 2018
  4. Study completion4 Jan 2018

Why it stopped: Study terminated by Sponsor following a recommendation from external DMC based on lack of emerging benefit; there were no new emergent safety findings

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641392
Sponsor's protocol ID
GED-0301-CD-004
Status last verified
Jan 2019
First submitted
23 Dec 2015
Last updated
29 Jan 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GED-0301 in people with Crohn's Disease, run by Celgene at 231 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in Germany, United States, Canada, France, Italy and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208 (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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