GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

— SHIELD-2  

Official title:

A 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01316939
• Other study ID #: 114157
• Secondary ID: 2010-022383-12
• Status: Terminated
• Phase: Phase 3
• First received: March 3, 2011
• Last updated: March 13, 2014
• Start date: May 2011
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeCanada: Health CanadaBelgium: Federal Agency for Medicines and Health Products, FAMHPUnited States: Food and Drug AdministrationNorway: Norwegian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Bundesinstitut für Arzneimittel und MedizinprodukteDenmark: Danish Medicines AgencyJapan: Pharmaceuticals and Medical Devices AgencySweden: Medical Products AgencyEurope: European Medicines Agency
• Study type: Interventional

Clinical Trial Summary

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

Description:

This is a multi-centre, randomised, placebo-controlled, double-blind parallel group study in adult subjects with Crohn's disease who previously achieved clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior Phase III induction study (Study CCX114151 or another GSK sponsored induction study). Subjects will be randomised to 52 weeks of oral treatment with GSK1605786A 500 mg once daily or 500 mg twice daily or placebo. Subjects who are receiving concomitant corticosteroids at entry will undergo dose tapering following a defined schedule. Subjects who complete the treatment period may be eligible to enter an open-label extension study. Subjects who experience disease worsening and require additional (rescue) treatment will be withdrawn and may be eligible to enter the open-label study. Subjects who do not enter the open-label study must complete a follow-up assessment 4 weeks after completion of treatment. Approximately 756 subjects will be enrolled.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 229
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects achieving clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study

• Written informed consent prior to any CCX114157 specific study procedures

• Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of less than 1 percent

• Stable doses of Crohn's disease medications

• Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose taper during the study

Exclusion Criteria:

• If female, is pregnant, has a positive pregnancy test or is breast-feeding

• Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study.

• Known or suspected fixed symptomatic small bowel stricture

• Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period

• Current sepsis or infections requiring intravenous antibiotic therapy for greater than 2 weeks

• Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• GSK1605786A
GSK1605786A 500 milligrams once daily
• Placebo
Placebo
• GSK1605786A
GSK1605786A 500 milligrams twice daily

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Bankstown	New South Wales
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Fitzroy	Victoria
Australia	GSK Investigational Site	Fremantle	Western Australia
Australia	GSK Investigational Site	Hersten	Queensland
Australia	GSK Investigational Site	Kurralta Park	South Australia
Australia	GSK Investigational Site	Prahran	Victoria
Austria	GSK Investigational Site	Hall in Tirol
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Oberpullendorf
Austria	GSK Investigational Site	St.Veit/Glan
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Austria	GSK Investigational Site	Wien
Belgium	GSK Investigational Site	Bonheiden
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Kortrijk
Belgium	GSK Investigational Site	Leuven
Belgium	GSK Investigational Site	Roeselare
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Canada	GSK Investigational Site	Abbotsford	British Columbia
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Kingston	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Winnipeg	Manitoba
Chile	GSK Investigational Site	Vina del Mar
Czech Republic	GSK Investigational Site	Hradec Králové
Czech Republic	GSK Investigational Site	Olomouc
Czech Republic	GSK Investigational Site	Ostrava - Vitkovice
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Praha 4
Czech Republic	GSK Investigational Site	Praha 7
Czech Republic	GSK Investigational Site	Praha 9
Denmark	GSK Investigational Site	Aalborg
Denmark	GSK Investigational Site	Aarhus
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Hvidovre
Denmark	GSK Investigational Site	Odense
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Clichy cedex
France	GSK Investigational Site	Lille cedex
France	GSK Investigational Site	Nantes cedex 1
France	GSK Investigational Site	Nice cedex 3
France	GSK Investigational Site	Paris cedex 10
France	GSK Investigational Site	Pessac cedex
France	GSK Investigational Site	Saint-Priest en Jarez
France	GSK Investigational Site	Vandoeuvre Les Nancy
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Brinkum/Stuhr	Niedersachsen
Germany	GSK Investigational Site	Frankfurt am Main	Hessen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Minden	Nordrhein-Westfalen
Germany	GSK Investigational Site	Ulm	Baden-Wuerttemberg
Hong Kong	GSK Investigational Site	Hong Kong
Hong Kong	GSK Investigational Site	Shatin, New Territories
Hungary	GSK Investigational Site	Bekescsaba
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Debrecen
Hungary	GSK Investigational Site	Mosonmagyaróvár
Hungary	GSK Investigational Site	Szekszárd
Hungary	GSK Investigational Site	Vác
Israel	GSK Investigational Site	Afula
Israel	GSK Investigational Site	Beer Sheva
Israel	GSK Investigational Site	Haifa
Israel	GSK Investigational Site	Holon
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Jerusalem
Israel	GSK Investigational Site	Kfar Saba
Israel	GSK Investigational Site	Petah Tikva
Israel	GSK Investigational Site	Ramat-Gan
Israel	GSK Investigational Site	Tel Aviv
Israel	GSK Investigational Site	Zerifin
Italy	GSK Investigational Site	Genova
Italy	GSK Investigational Site	Modena
Italy	GSK Investigational Site	Palermo	Sicilia
Italy	GSK Investigational Site	Roma
Italy	GSK Investigational Site	Roma
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Pusan
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Wonju
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	EDE
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Rotterdam
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Lower Hutt
New Zealand	GSK Investigational Site	Otahuhu, Auckland
New Zealand	GSK Investigational Site	Tauranga.
Norway	GSK Investigational Site	Tønsberg
Norway	GSK Investigational Site	Tromsø
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Sopot
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Wroclaw
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Lisboa
Portugal	GSK Investigational Site	Porto
Portugal	GSK Investigational Site	Viseu
Russian Federation	GSK Investigational Site	Irkutsk
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Lipetsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Nizhniy Novgorod
Russian Federation	GSK Investigational Site	Rostov-on-Don
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Tomsk
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Nove Mesto nad Vahom
Slovakia	GSK Investigational Site	Presov
Slovakia	GSK Investigational Site	Trnava
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Claremont
South Africa	GSK Investigational Site	Observatory
South Africa	GSK Investigational Site	Parktown
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Elche
Spain	GSK Investigational Site	Fuenlabrada (Madrid)
Spain	GSK Investigational Site	Galdakao/Vizcaya
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Marbella
Spain	GSK Investigational Site	Sabadell (Barcelona)
Spain	GSK Investigational Site	Santander
Sweden	GSK Investigational Site	Lund
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
Switzerland	GSK Investigational Site	Bern
Switzerland	GSK Investigational Site	Zürich
Taiwan	GSK Investigational Site	Taichung
Turkey	GSK Investigational Site	Ankara
Ukraine	GSK Investigational Site	Chernivtsi
Ukraine	GSK Investigational Site	Dnipropetrovsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Donetsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Odesa
Ukraine	GSK Investigational Site	Simferopol
Ukraine	GSK Investigational Site	Vinnytsya
United Kingdom	GSK Investigational Site	Birmingham
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Edinburgh
United Kingdom	GSK Investigational Site	Harrow	Middlesex
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Newcastle-upon-Tyne
United Kingdom	GSK Investigational Site	Oxford
United Kingdom	GSK Investigational Site	Salford
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Aurora	Colorado
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Chapel Hill	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Chesterfield	Michigan
United States	GSK Investigational Site	Chevy Chase	Maryland
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Christiansburg	Virginia
United States	GSK Investigational Site	Columbus	Ohio
United States	GSK Investigational Site	Danville	Virginia
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	East Setauket	New York
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Hamden	Connecticut
United States	GSK Investigational Site	Hammond	Louisiana
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	La Jolla	California
United States	GSK Investigational Site	Lake Success	New York
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Lee's Summit	Missouri
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Little Rock	Arizona
United States	GSK Investigational Site	Littleton	Colorado
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Mexico	Missouri
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Monroe	Louisiana
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Haven	Connecticut
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Port Orange	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	Minnesota
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	South Towson	Maryland
United States	GSK Investigational Site	Suwanee	Georgia
United States	GSK Investigational Site	Towson	Maryland
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Chile,  Czech Republic,  Denmark,  Estonia,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission (CDAI score less than 150 points)	Proportion of subjects in clinical remission (CDAI score less than 150 points)	At both Weeks 28 and 52	No
Secondary	Corticosteroid-free remission	Proportion of subjects in clinical remission (CDAI score less than 150 points) and not taking corticosteroids	At both Weeks 28 and 52	No
Secondary	Remission in subjects who were in remission at baseline	Proportion of subjects in clinical remission (CDAI score less than 150 points) in subjects who were in remission at baseline	At both Weeks 28 and 52	No
Secondary	Remission at end of treatment	Proportion of subject in clinical remission (CDAI score less than 150 points) at end of treatment	Week 52	No
Secondary	Clinical response (CDAI decrease of at least 100 points)	Proportion of subjects with clinical response (CDAI decrease of at least 100 points)	At both Weeks 28 and 52	No
Secondary	Induction of remission in subjects who were not in remission at baseline	Time to induction of remission in subjects who were not in remission at baseline	52 weeks	No
Secondary	Change from baseline in CDAI score	Change from baseline in CDAI score at various timepoints over the treatment period	Weeks 4, 8, 12, 20, 28, 36, 44, 52	No
Secondary	Safety outcomes	Change from baseline in safety measures and incidence of adverse events and serious adverse events	52 weeks	No
Secondary	Health outcomes	Change from baseline in quality of life measures	52 weeks	No
Secondary	Biomarkers	Change from baseline in C-reactive protein and faecal calprotectin	52 weeks	No