Clinical trial NCT01277666: A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's disease
capsule
GSK1605786A
quality of life
inflammatory bowel disease
oral therapy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is 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 as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

Detailed description: This is a multi-centre, randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of two oral doses of GSK1605786A (500 mg once daily, 500 mg twice daily) as compared to placebo in the induction of clinical response over a 12-week treatment period in subjects with moderately-to-severely active Crohn's disease. Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of remission.

The study is planned to randomise approximately 600 subjects (200 subjects/group) with active Crohn's disease, diagnosed for at least 4 months with a documented history of disease in the small and/or large intestine, and characterised by a Crohn's Disease Activity Index (CDAI) score between 220 to and 450, inclusive. Subjects must have reported an inadequate response or intolerance to Crohn's disease treatment with corticosteroids or immunosuppressants. Inclusion of subjects who received prior treatment with a biologic anti-tumour necrosis factor (TNF) agent will be limited to approximately 50% of the study population. All subjects are required to have a diagnosis with identification of anatomic location of Crohn's disease, which has been established by visualisation of the gastrointestinal tract within 12 months of screening. Subjects who have not had a visualisation of the gastrointestinal tract within 12 months are required to undergo an endoscopic assessment during the screening period. Subjects will be required to have evidence of current active inflammation at the time of randomisation either by endoscopy or by inflammatory biomarkers \[elevated C-reactive protein (CRP) greater than the upper limit of normal (ULN) plus a positive faecal calprotectin test\]. Subjects who do not meet the requirements based on inflammatory biomarker test results will be required to qualify based on endoscopic assessment during screening. Subjects will be allowed to participate in the study while continuing on stable doses of agents typically used to treat Crohn's disease. Following the screening period, subjects will be randomised at baseline to receive blinded treatment with one of two doses of GSK1605786A (500 mg once daily or twice daily) or placebo for 12 weeks. Response and remission endpoints, using the CDAI, will be evaluated at Weeks 4, 8 and 12.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Written informed consent
* Diagnosis of Crohn's disease for greater than 4 months duration with small bowel and/or colonic involvement
* Confirmation of Crohn's disease established by visualisation of the gastrointestinal tract within the 12 months prior to screening or by screening endoscopy at study entry
* History of inadequate response and/or intolerance/adverse event leading to discontinuation of either corticosteroids or immunosuppressants
* Moderately-to-severely active disease characterised by a CDAI score between 220 and 450, inclusive, at Baseline
* Confirmation of current active Crohn's disease by screening endoscopy or inflammatory biomarkers \[elevated C-reactive protein (greater than upper limit of normal) plus positive test for faecal calprotectin\] at Screening
* Stable doses of permitted concomitant medications or having previously received, but are not currently receiving, medications for Crohn's disease
* Demonstrated ability to comply with Crohn's disease symptom recording using the interactive voice response system
* Females of child-bearing potential must be sexually inactive or commit to consistent and correct use of a contraceptive method of birth control with a failure rate of less than 1% for the duration of this study

Exclusion Criteria:

* If female: pregnant, has a positive pregnancy test or is breast-feeding
* Diagnosis of coeliac disease, follow a gluten-free diet to manage symptoms, or positive test for coeliac disease
* Diagnosis of ulcerative or indeterminate colitis
* Enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period
* Bowel surgery, other than appendectomy, within 12 weeks prior to screen and/or has surgery planned or deemed likely for Crohn's disease during the study period
* Extensive colonic resection, subtotal or total colectomy
* Presence of ileostomies, colostomies or rectal pouches
* Known fixed symptomatic stenoses
* History of more than 3 small bowel resections or diagnosis of short bowel syndrome
* Chronic use of narcotics for chronic pain defined as daily use of one or more doses of narcotic containing medication
* Use of prohibited medications, including enteral feeding or elemental diet, within their specified time frames

  1. Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening
  2. Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening
  3. Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening
  4. Intravenous antibiotic use: Use of intravenous antibiotics for Crohn's disease within 4 weeks prior to screening
  5. Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to screening
  6. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening
  7. Leukocytapheresis or granulocytapheresis within 2 weeks prior to screening
* Positive immunoassay for Clostridium difficile
* Known human immunodeficiency virus (HIV) infection
* Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
* Immunisation with a live vaccine within 4 weeks of screening, with the exception of influenza vaccine
* Active or latent tuberculosis infection
* Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
* Evidence of hepatic dysfunction, viral hepatitis, or current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH)
* Positive test for Hepatitis B or Hepatitis C antibody at screening
* Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
* Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study
* History or evidence of adenomatous colonic polyps that have not been removed
* History of evidence of colonic mucosal dysplasia
* Current evidence of, or has been treated for a malignancy within the past five years (other than localised basal cell, squamous cell skin cancer, cervical dysplasia, or any cancer in situ that has been resected)
* Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
* Medical history of sensitivity to any of the components of GSK1605786A
* Use of any investigational product within 30 days prior to screening

Primary outcomes:
measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With CDAI Remission at Week 12
timeFrame: Week 12
measure: Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >= 100 Points) at Both Week 8 and Week 12
timeFrame: At Week 8 and 12
measure: Percentage of Participants Achieving Clinical Remission (CDAI <150 Points) at Both Week 8 and Week 12
timeFrame: Week 8 and 12
measure: Percentage of Participants With a Clinical Response (CDAI Decrease From Baseline of >=100 Points) at Week 8
timeFrame: Week 8
measure: Percentage of Participant Achieving Clinical Remission (CDAI <150 Points) at Week 8
timeFrame: Week 8
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Both Weeks 8 and 12
timeFrame: Baseline (Week 0), Week 8 and Week 12
measure: Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
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facility: GSK Investigational Site
state: Arizona
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state: California
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city: Lakewood
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state: Colorado
city: Littleton
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facility: GSK Investigational Site
state: Colorado
city: Hamden
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state: Connecticut
city: Jacksonville
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facility: GSK Investigational Site
state: Florida
city: Jacksonville
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facility: GSK Investigational Site
state: Florida
city: Maitland
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state: Florida
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state: Georgia
city: Chicago
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state: Illinois
city: Oak Lawn
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state: Illinois
city: Indianapolis
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state: Indiana
city: Lexington
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state: Kentucky
city: Hammond
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state: Louisiana
city: Monroe
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state: Louisiana
city: Chevy Chase
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state: Maryland
city: Towson
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facility: GSK Investigational Site
state: Maryland
city: Boston
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state: Massachusetts
city: Ann Arbor
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state: Michigan
city: Chesterfield
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state: Michigan
city: Troy
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state: Michigan
city: Rochester
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state: Minnesota
city: Jackson
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state: Mississippi
city: Tupelo
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state: Mississippi
city: Lee's Summit
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state: Missouri
city: Lebanon
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state: New Hampshire
city: Egg Harbor City
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state: New Jersey
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state: New York
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state: North Carolina
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state: North Carolina
city: Raleigh
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state: North Carolina
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city: Nashville
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state: South Australia
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state: South Australia
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state: Victoria
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state: Victoria
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state: Western Australia
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city: Linz
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city: Wien
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city: Wien
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city: Bonheiden
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facility: GSK Investigational Site
city: Brussels
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city: Brussels
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city: Edegem
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city: Gent
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city: Kortrijk
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city: Leuven
country: Belgium
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city: Roeselare
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city: Calgary
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state: Alberta
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state: British Columbia
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state: British Columbia
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state: Manitoba
city: Halifax
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facility: GSK Investigational Site
state: Nova Scotia
city: Hamilton
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state: Ontario
city: Hamilton
country: Canada
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state: Ontario
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
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state: Ontario
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state: Ontario
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state: Ontario
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country: Canada
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state: Quebec
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Montreal
country: Canada
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state: Quebec
city: Quebec
country: Canada
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city: Quebec
country: Canada
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city: Brno
country: Czechia
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
facility: GSK Investigational Site
city: Praha 10
country: Czechia
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city: Praha 4
country: Czechia
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country: Czechia
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country: Czechia
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country: Denmark
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country: Denmark
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city: Hvidovre
country: Denmark
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city: Odense
country: Denmark
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city: Amiens cedex 1
country: France
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country: France
facility: GSK Investigational Site
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country: France
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city: Nantes cedex 1
country: France
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city: Nice cedex 3
country: France
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city: Paris cedex 10
country: France
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country: France
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country: France
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country: France
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city: Freiburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
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country: Germany
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state: Baden-Wuerttemberg
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state: Nordrhein-Westfalen
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country: Germany
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state: Nordrhein-Westfalen
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country: Germany
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state: Nordrhein-Westfalen
city: Muenster
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Dessau
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Jena
country: Germany
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state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Bekescsaba
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Szekszárd
country: Hungary
facility: GSK Investigational Site
city: Haifa
country: Israel
facility: GSK Investigational Site
city: Holon
country: Israel
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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: Petach Tikva
country: Israel
facility: GSK Investigational Site
city: Tel Aviv
country: Israel
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city: Palermo
country: Italy
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state: Sicilia
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country: Italy
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country: Italy
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city: Roma
country: Italy
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city: Aichi
country: Japan
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city: Aichi
country: Japan
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country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
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city: Fukuoka
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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city: Tokyo
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city: Daegu
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country: Netherlands
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city: Amsterdam
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facility: GSK Investigational Site
city: Amsterdam
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city: EDE
country: Netherlands
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city: Heerlen
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Auckland
country: New Zealand
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city: Dunedin
country: New Zealand
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city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Lower Hutt
country: New Zealand
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city: Tauranga.
country: New Zealand
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city: Bodø
country: Norway
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city: Oslo
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city: Tromsø
country: Norway
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city: Trondheim
country: Norway
facility: GSK Investigational Site
city: Tønsberg
country: Norway
facility: GSK Investigational Site
city: Ålesund
country: Norway
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Bydgoszcz
country: Poland
facility: GSK Investigational Site
city: Elblag
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
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: Galdakao/Vizcaya
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Sabadell (Barcelona)
country: Spain
facility: GSK Investigational Site
city: Göteborg
country: Sweden
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: Umeå
country: Sweden
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: Nottingham
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: