Clinical trial NCT01318993: Open-Label Extension Study of GSK1605786A
Official title: An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: GSK1605786A; Inflammatory Bowel Disease; Crohn's disease; long-term treatment; quality of life; CCR9 antagonist
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-03-21
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

Detailed description: This is a multi-centre, open-label extension study to assess the long-term safety, tolerability and effectiveness of GSK1605786A in subjects with Crohn's disease. Subjects will enter the study via one of three routes:

1. completion of the placebo-controlled induction study, CCX114151, without achieving clinical response (CDAI decrease of at least 100 points) or clinical remission (CDAI score less than 150) at Week 12 or completion of any other GSK-sponsored induction study as designated by the sponsor
2. completion of maintenance study CCX114157 at Week 52
3. withdrawal from maintenance study CCX114157 due to worsening of Crohn's disease and requiring a treatment change.

The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability.

It is estimated that approximately 800 subjects will be enrolled in total. All subjects will enter the study at baseline (Week 0) and commence oral treatment with GSK1605786A 500 mg twice daily.

The study will be conducted for 108 weeks. Once the results of the induction study CCX114151 are known, the risk-to-benefit ratio will be re-assessed and the study duration may be amended.

Study assessments for Crohn's disease will be performed every 12 weeks through Week 108. At week 12, the investigator will make a determination of whether the subject is receiving clinical benefit, and subjects who are not receiving clinical benefit must be withdrawn. More frequent blood draws are required for liver function testing only; every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 12 weeks after Week 60 for the duration of the study.

Eligibility criteria: Inclusion Criteria:

* Previous participation in a GSK-sponsored study with GSK1605786A
* Written informed consent prior to any study-specific procedures
* Female subjects: To be eligible, females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with less than 1% failure rate

Exclusion Criteria:

* If female, is pregnant, has a positive pregnancy test or is breast-feeding, or is planning to become pregnant
* Subjects with known or suspected coeliac disease or a positive screening test for anti-tissue transglutaminase antibodies should have been excluded from enrolment into any induction study. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tissue transglutaminase antibodies and excluded or withdrawn from the study upon positive test result
* Fixed symptomatic stenoses or strictures of small bowel or colon
* Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
* Current sepsis or infections requiring intravenous antibiotic therapy greater than 2 weeks
* Evidence of hepatic dysfunction or viral hepatitis
* Subjects who have demonstrated safety or tolerability issues during participation in a previous study with GSK1605786A which, in the opinion of the investigator, was possibly related to study treatment and poses an unacceptable risk to the subject.

Primary outcomes:
measure: Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE)
timeFrame: Up to Week 112
Secondary outcomes:
measure: Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period
timeFrame: Baseline (Week 0) and up to Week 112
measure: Change From Baseline (Week 0) in Heart Rate (HR) Over Period
timeFrame: Baseline (week 0) and up to Week 112
measure: Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters
timeFrame: Baseline (Week 0) and up to Week 112
measure: Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters
timeFrame: Baseline (Week 0) and up to Week 112
measure: Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT)
timeFrame: Baseline (Week 0) and up to Week 112
measure: Change From Baseline (Week 0) in Total Bilirubin
timeFrame: Baseline (Week 0) and up to Week 112
measure: Change From Baseline (Week 0) in Albumin
timeFrame: Baseline (Week 0) and up to Week 112
measure: Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value
timeFrame: Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment)
measure: Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks
timeFrame: Baseline (Week 0) and up to 108 weeks
measure: Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks
timeFrame: Baseline (Week 0) and up to 108 weeks
measure: Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks
timeFrame: Baseline (Week 0) and up to 112 weeks
measure: Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks
timeFrame: Baseline (Week 0) and up to 112 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Anaheim
country: United States
facility: GSK Investigational Site
state: California
city: La Jolla
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facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
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facility: GSK Investigational Site
state: California
city: Aurora
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facility: GSK Investigational Site
state: Colorado
city: Lakewood
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facility: GSK Investigational Site
state: Colorado
city: Littleton
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facility: GSK Investigational Site
state: Colorado
city: Hamden
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facility: GSK Investigational Site
state: Connecticut
city: New Haven
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facility: GSK Investigational Site
state: Connecticut
city: Washington, D.C.
country: United States
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state: District of Columbia
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Port Orange
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facility: GSK Investigational Site
state: Florida
city: Atlanta
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facility: GSK Investigational Site
state: Georgia
city: Suwanee
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state: Georgia
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facility: GSK Investigational Site
state: Illinois
city: Indianapolis
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facility: GSK Investigational Site
state: Indiana
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facility: GSK Investigational Site
state: Kentucky
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state: Louisiana
city: Monroe
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state: Louisiana
city: Chevy Chase
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facility: GSK Investigational Site
state: Maryland
city: Towson
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facility: GSK Investigational Site
state: Maryland
city: Towson
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facility: GSK Investigational Site
state: Maryland
city: Boston
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facility: GSK Investigational Site
state: Massachusetts
city: Ann Arbor
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facility: GSK Investigational Site
state: Michigan
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facility: GSK Investigational Site
state: Michigan
city: Troy
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facility: GSK Investigational Site
state: Michigan
city: Rochester
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facility: GSK Investigational Site
state: Minnesota
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country: United States
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city: Mexico
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state: North Carolina
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facility: GSK Investigational Site
state: North Carolina
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state: North Carolina
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state: Oregon
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facility: GSK Investigational Site
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state: Tennessee
city: Nashville
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state: Tennessee
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state: Utah
city: Christiansburg
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state: Virginia
city: Danville
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facility: GSK Investigational Site
state: Virginia
city: Norfolk
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facility: GSK Investigational Site
state: Virginia
city: Richmond
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state: Virginia
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state: Washington
city: Seattle
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facility: GSK Investigational Site
state: Wisconsin
city: Milwaukee
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state: Wisconsin
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state: New South Wales
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state: Queensland
city: Adelaide
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state: South Australia
city: Kurralta Park
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state: South Australia
city: Box Hill
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state: Victoria
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state: Victoria
city: Prahran
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state: Victoria
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country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Hall in Tirol
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facility: GSK Investigational Site
city: Linz
country: Austria
facility: GSK Investigational Site
city: Oberpullendorf
country: Austria
facility: GSK Investigational Site
city: St.Veit/Glan
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Bonheiden
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facility: GSK Investigational Site
city: Brussels
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facility: GSK Investigational Site
city: Brussels
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Kortrijk
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Roeselare
country: Belgium
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city: Plovdiv
country: Bulgaria
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city: Sofia
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city: Sofia
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city: Sofia
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city: Varna
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city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Edmonton
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facility: GSK Investigational Site
state: Alberta
city: Abbotsford
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state: British Columbia
city: Vancouver
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state: British Columbia
city: Winnipeg
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state: Manitoba
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Hamilton
country: Canada
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state: Ontario
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
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facility: GSK Investigational Site
state: Ontario
city: London
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state: Ontario
city: Ottawa
country: Canada
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state: Ontario
city: Montreal
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state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Quebec
country: Canada
facility: GSK Investigational Site
city: Vina del Mar
country: Chile
facility: GSK Investigational Site
city: Hradec Králové
country: Czechia
facility: GSK Investigational Site
city: Olomouc
country: Czechia
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city: Ostrava - Vitkovice
country: Czechia
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country: Czechia
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city: Praha 4
country: Czechia
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country: Czechia
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city: Praha 9
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city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Aarhus
country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Clichy cedex
country: France
facility: GSK Investigational Site
city: Lille cedex
country: France
facility: GSK Investigational Site
city: Nantes cedex 1
country: France
facility: GSK Investigational Site
city: Nice cedex 3
country: France
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city: Paris cedex 10
country: France
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city: Pessac cedex
country: France
facility: GSK Investigational Site
city: Saint-Priest en Jarez
country: France
facility: GSK Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: GSK Investigational Site
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Frankfurt am Main
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
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country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
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city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
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city: Hong Kong
country: Hong Kong
facility: GSK Investigational Site
city: Shatin, New Territories
country: Hong Kong
facility: GSK Investigational Site
city: Bekescsaba
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Mosonmagyaróvár
country: Hungary
facility: GSK Investigational Site
city: Szekszárd
country: Hungary
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city: Vác
country: Hungary
facility: GSK Investigational Site
city: Afula
country: Israel
facility: GSK Investigational Site
city: Beer Sheva
country: Israel
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city: Haifa
country: Israel
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city: Holon
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Jerusalem
country: Israel
facility: GSK Investigational Site
city: Kfar Saba
country: Israel
facility: GSK Investigational Site
city: Petah Tikva
country: Israel
facility: GSK Investigational Site
city: Ramat-Gan
country: Israel
facility: GSK Investigational Site
city: Tel Aviv
country: Israel
facility: GSK Investigational Site
city: Zerifin
country: Israel
facility: GSK Investigational Site
city: Genova
country: Italy
facility: GSK Investigational Site
state: Liguria
city: Palermo
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Modena
country: Italy
facility: GSK Investigational Site
city: Roma
country: Italy
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
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city: Hiroshima
country: Japan
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city: Hokkaido
country: Japan
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country: Japan
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city: Kagoshima
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country: Japan
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city: Tokyo
country: Japan
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city: Tokyo
country: Japan
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city: Busan
country: Korea, Republic of
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Wonju
country: Korea, Republic of
facility: GSK Investigational Site
city: Dunedin
country: New Zealand
facility: GSK Investigational Site
city: Lower Hutt
country: New Zealand
facility: GSK Investigational Site
city: Otahuhu, Auckland
country: New Zealand
facility: GSK Investigational Site
city: Tauranga.
country: New Zealand
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Sopot
country: Poland
facility: GSK Investigational Site
city: Torun
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
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city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
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city: Viseu
country: Portugal
facility: GSK Investigational Site
city: Kazan
country: Russian Federation
facility: GSK Investigational Site
city: Lipetsk
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Nizhniy Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: GSK Investigational Site
city: Samara
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
city: Nitra
country: Slovakia
facility: GSK Investigational Site
city: Nove Mesto nad Vahom
country: Slovakia
facility: GSK Investigational Site
city: Presov
country: Slovakia
facility: GSK Investigational Site
city: Trnava
country: Slovakia
facility: GSK Investigational Site
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Claremont
country: South Africa
facility: GSK Investigational Site
city: Observatory
country: South Africa
facility: GSK Investigational Site
city: Parktown
country: South Africa
facility: GSK Investigational Site
city: Badalona
country: Spain
facility: GSK Investigational Site
city: Elche
country: Spain
facility: GSK Investigational Site
city: Fuenlabrada (Madrid)
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Lund
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: Zürich
country: Switzerland
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Chernivtsi
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Odesa
country: Ukraine
facility: GSK Investigational Site
city: Simferopol
country: Ukraine
facility: GSK Investigational Site
city: Vinnytsya
country: Ukraine
facility: GSK Investigational Site
city: Harrow
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Bristol
country: United Kingdom
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: GSK Investigational Site
city: Oxford
country: United Kingdom
facility: GSK Investigational Site
city: Salford
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: