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

NCT ID: NCT02641392

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-25
• Study Completion Date: 2018-01-04

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

GED-0301

Intervention Type: DRUG

Mongersen

Intermittent GED-0301 160 mg and placebo

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

Group Type: EXPERIMENTAL

GED-0301

Intervention Type: DRUG

Mongersen

Placebo

Intervention Type: OTHER

Placebo

Intermittent placebo and GED-0301 40 mg

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

Group Type: EXPERIMENTAL

GED-0301

Intervention Type: DRUG

Mongersen

Placebo

Intervention Type: OTHER

Placebo

Continuous GED-0301 40 mg

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

Group Type: EXPERIMENTAL

GED-0301

Intervention Type: DRUG

Mongersen

Intermittent placebo and GED-0301 160 mg

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

Group Type: EXPERIMENTAL

GED-0301

Intervention Type: DRUG

Mongersen

Placebo

Intervention Type: OTHER

Placebo

Interventions

GED-0301

Mongersen

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Other Intervention Names

Mongersen

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillermo Rossiter, MD

Role: STUDY_DIRECTOR

Celgene

Locations

Medical Associates Research Group Inc.

San Diego, California, United States

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, United States

Indiana University

Indianapolis, Indiana, United States

Health Science Research Center, LLC

Pratt, Kansas, United States

Via Christi Research a division of Via Christi Hospitals Wichita Inc

Wichita, Kansas, United States

Gastroenterology Associates LLC

Baton Rouge, Louisiana, United States

Metropolitan Gastroenterology

Chevy Chase, Maryland, United States

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, United States

Gastroenterology Associates of Western Michigan PLC

Wyoming, Michigan, United States

Ehrhardt Clinical Research LLC

Belton, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Trial Management Associates LLC

Wilmington, North Carolina, United States

ClinSearch LLC

Chattanooga, Tennessee, United States

Texas Clinical Research Institute LLC

Arlington, Texas, United States

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, United States

Texas Digestive Disease Consultants - Southlake

Flower Mound, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Sagact Pllc

San Antonio, Texas, United States

San Antonio Military Medical Center

San Antonio, Texas, United States

Digestive Health Specialists of Tyler

Tyler, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Washington School of Medicine

Seattle, Washington, United States

The Vancouver Clinic

Vancouver, Washington, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Centre For Digestive Diseases

Five Dock, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Mater Adult Hospital

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Monash Medical Centre Clayton

Bentleigh East, , Australia

LKH Universitaetsklinikum Graz

Graz, , Austria

Medizinische Universitat Innsbruck

Innsbruck, , Austria

KH der Barmherzigen Bruder Linz

Linz, , Austria

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

KH der Barmherzigen Brüder St.Veit an der Glan

Sankt Veit an der Glan, , Austria

Krankenanstalt Rudolfstiftung Wien

Wein, , Austria

AKH Medizinische Universitat Wien

Wein, , Austria

Universitair Ziekenhuis Brussel

Brussels, , Belgium

UZ Leuven

Leuven, , Belgium

CHU Sart Tilman

Liège, , Belgium

MHAT Kaspela EOOD

Plovdiv, , Bulgaria

MHAT Ruse AD

Rousse, , Bulgaria

Second MHAT Sofia AD

Sofia, , Bulgaria

City Clinic UMHAC EOOD

Sofia, , Bulgaria

UMHAT Sv Ivan Rilski EAD

Sofia, , Bulgaria

UMHAT Tsaritsa Yoanna - ISUL EAD

Sofia, , Bulgaria

MHAT Doverie AD

Sofia, , Bulgaria

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

South Edmonton Gastroenterology

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

GI Research Institute

Vancouver, British Columbia, Canada

PerCuro Clinical Research

Victoria, British Columbia, Canada

Brandon Medical Arts Clinic

Brandon, Manitoba, Canada

McMaster University Health Sciences Center

Hamilton, Ontario, Canada

London Health Science Center U. Hospital

London, Ontario, Canada

LHSC Victoria Hospital

London, Ontario, Canada

Montfort Hospital

Ottawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Toronto Digestive Disease Associates Inc

Vaughan, Ontario, Canada

Medicine Professional Corporation

Waterloo, Ontario, Canada

Centre de sante et de services sociaux Champlain Charles Le Moyne

Greenfield Park, Quebec, Canada

McGill University Health Centre Glen Site Royal Victoria Hospital

Montreal, Quebec, Canada

Clinical Hospital Centre Osijek

Osijek, , Croatia

Fakultni nemocnice u sv Anny v Brne

Brno, , Czechia

Hepato-Gastroenterologie HK

Hradec Králové, , Czechia

PreventaMed

Olomouc, , Czechia

CCBR Prague CZ

Prague, , Czechia

Aarhus Universitetshospital

Aahus C, , Denmark

Alborg Universitets Hospital

Aalborg, , Denmark

Nordsjaellands Hospital Frederikssund

Frederikssund, , Denmark

Herlev Hospital

Herlev, , Denmark

Koge Sygehus

Køge, , Denmark

Regionshospitalet Silkeborg

Silkeborg, , Denmark

CHU Amiens Hopital Sud

Amiens, , France

CHU Besancon Hopital Jean Minjoz

Besançon, , France

CHU Tours Hopital Trousseau

Chambray-lès-Tours, , France

CHU Clermont Ferrand

Clermont-Ferrand, , France

Hopital Beaujon

Clichy, , France

CHU Nantes Hotel Dieu

Nantes, , France

CHU Nice Hopital de lArchet 2

Nice, , France

Groupe Hospitalier Sud Hopital Haut Leveque USN

Pessac, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

CHU Reims Hopital Robert Debre

Reims, , France

CHU Rennes Hopital Pontchaillou

Rennes, , France

CHU Saint Etienne Hopital Nord

Saint-Etienne, , France

CHU Strasbourg Hopital Hautepierre

Strasbourg, , France

CHU de Toulouse Hopital Rangueil

Toulouse, , France

Hopital de Brabois Adultes

Vandœuvre-lès-Nancy, , France

Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

Berlin, , Germany

DRK Kliniken Berlin Westend

Berlin, , Germany

Krankenhaus Waldfriede e V

Berlin, , Germany

Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

Bochum, , Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , Germany

Universitaetsklinikum Erlangen

Erlangen, , Germany

Kliniken Essen-Mitte

Essen, , Germany

Agaplesion Markus Krankenhaus

Frankfurt, , Germany

Universitaetsklinikum Halle Saale

Halle, , Germany

Asklepios Klinik Hamburg

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

Heidelberg, , Germany

Universitaetsklinikum Jena

Jena, , Germany

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, , Germany

University Leipzig

Leipzig, , Germany

EUGASTRO GmbH

Leipzig, , Germany

Medizinisches Zentrum Klinikum Lueneburg

Lüneburg, , Germany

Klinikum Mannheim GmbH Universitaetsklinikum

Mannheim, , Germany

Klinikum der Universitaet Muenchen

München, , Germany

Gastro Campus Research

Münster, , Germany

Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

Niedersachsen, , Germany

Universitaetsklinikum Regensburg

Regensburg, , Germany

Universitaetsklinikum Ulm

Ulm, , Germany

University General Hospital of Alexandroupolis

Alexandroupoli, , Greece

General Hospital of Athens Evangelismos

Athens, , Greece

Athens Medical Center

Athens, , Greece

University General Hospital of Patras

Rio Patras, , Greece

DRC Gyogyszervizsgalo Kozpont Kft

Balatonfüred, , Hungary

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

Semmelweis Egyetem AOK

Budapest, , Hungary

Endomedix Diagnosztikai Kozpont

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

Dunaújváros, , Hungary

Petz Aladar Megyei Oktato Korhaz

Győr, , Hungary

Clinfan Szolgaltato Kft

Szekszárd, , Hungary

HaEmek Medical Center

Afula, , Israel

Soroka University Medical Center

Beersheba, , Israel

Rambam Health Care Campus

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Hadassah University Hospital

Jerusalem, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center Department of Hematology

Tel Aviv, , Israel

The Baruch Padeh MC, Poriya

Tiberias, , Israel

Assaf Harofeh Medical Center

Ẕerifin, , Israel

Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliera Universitaria Policlinico G Martino

Messina, , Italy

Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

Milan, , Italy

Azienda Ospedaliera Vincenzo Cervello

Palermo, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Universita Campus Bio Medico di Roma

Roma, , Italy

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Azienda Ospedaliera San Camillo Forlanini

Rome, , Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, , Italy

Istituto Clinico Humanitas

Rozzano (MI), , Italy

IRCCS Policlinico San Donato

San Donato Milanese, , Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo FG, , Italy

Digestive Diseases Center Gastro

Riga, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

VU Medisch Centrum

Amsterdam, , Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Radboudumc

Nijmegen, , Netherlands

Zuyderland Medisch Centrum

Sittard-Geleen, , Netherlands

St. Elisabeth Ziekenhuis

Tilburg, , Netherlands

Akershus universitetssykehus HF

Lørenskog, , Norway

Oslo Universitetssykehus Rikshospitalet

Oslo, , Norway

Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

Kielce, , Poland

Indywidualna Praktyka Lekarska Maciej Zymla

Knurów, , Poland

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

Lodz, , Poland

Centrum Medyczne Medyk

Rzeszów, , Poland

Endoskopia Sp. z o.o.

Sopot, , Poland

Hospital de Braga

Braga, , Portugal

Hospital da Senhora da Oliveira Guimaraes

Guimarães, , Portugal

S.C MedLife S.A

Bucharest, , Romania

CMI Dr. Tirnaveanu Amelita

Oradea, , Romania

Centrul de Gastroenterologie Dr. Goldis

Timișoara, , Romania

TSBIH Territorial Clinical Hospital

Krasnoyarsk, , Russia

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

Nizhny Novgorod, , Russia

SBEIHPE Novosibirsk State Medical University

Novosibirsk, , Russia

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

Novosibirsk, , Russia

Evromedservis

Pushkin, , Russia

SEIHPE Rostov State Medical University of MoH of RF

Rostov-on-Don, , Russia

SPb SBIH City Hospital # 26

Saint Petersburg, , Russia

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

Samara, , Russia

Clinical Center Zvezdara

Belgrade, , Serbia

Military Medical Academy

Belgrade, , Serbia

Clinical Center Bezanijska Kosa

Belgrade, , Serbia

Fakultna nemocnica s poliklinikou F. D. Roosevelta

Banská Bystrica, , Slovakia

Alian s.r.o.

Bardejov, , Slovakia

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

Malacky, , Slovakia

Fakultna nemocnica Nitra

Nitra, , Slovakia

KM Management, spol. s r.o.

Nitra, , Slovakia

GASTRO I., s.r.o.

Prešov, , Slovakia

Dong-A University Hospital

Busan, , South Korea

Pusan National University Hospital

Busan, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Hanyang University Guri Hospital

Guri-si, , South Korea

CHA Bundang Medical Center CHA University

Seongnam-si, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Kyung Hee University Hospital

Seoul, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Hospital del Mar

Barcelona, , Spain

Hospital Clinic I Provincial de Barcelona

Barcelona, , Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, , Spain

Corporacion Sanitaria Parc Tauli

Sabadell, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Danderyds Sjukhus AB

Stockholm, , Sweden

Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

Bern, , Switzerland

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Yeditepe University Medical School Hospital

Istanbul, , Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty Hospital

Istanbul, , Turkey (Türkiye)

Acibadem Fulya Hospital

Istanbul, , Turkey (Türkiye)

Haydarpasa Numune Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Istanbul Medeniyet Uni Goztepe Training&Res Hosp

Istanbul, , Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Kocaeli Derince Training and Research Hospital

Kocaeli, , Turkey (Türkiye)

RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

Chernivtsi, , Ukraine

CI of PH Kharkiv CCH #2

Kharkiv, , Ukraine

Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

Kirovohrad, , Ukraine

Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

Kyiv, , Ukraine

Kyiv City Clinical Hospital #1

Kyiv, , Ukraine

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

Kyiv, , Ukraine

CI Odesa Regional Clinical Hospital

Odesa, , Ukraine

Ternopil City Communal Emergency Medical Care Hospital

Ternopil, , Ukraine

CI Zaporizhzhia Regional Clinical Hospital of ZRC

Zaporizhzhya, , Ukraine

Royal Devon and Exeter Hospital Wonford

Exeter, , United Kingdom

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Glasgow Royal Infirmary

Glasgow, Scotland, , United Kingdom

Hull Royal Infirmary

Hull, , United Kingdom

Royal London Hospital

London, , United Kingdom

St Marys Hospital

London, , United Kingdom

Manchester Royal Infirmary

Manchester, , United Kingdom

Nottingham University Hospitals Queens Medical Centre

Nottingham, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Royal Shrewsbury Hospital

Shrewsbury, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Bulgaria; Canada; Croatia; Czechia; Denmark; France; Germany; Greece; Hungary; Israel; Italy; Latvia; Netherlands; Norway; Poland; Portugal; Romania; Russia; Serbia; Slovakia; South Korea; Spain; Sweden; Switzerland; Turkey (Türkiye); Ukraine; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GED-0301-CD-004

Identifier Type: -

Identifier Source: org_study_id