Clinical trial NCT01536418: An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
Official title: A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Crohn's disease, chemokine receptor 9 antagonist, Crohn's Disease Activity Index
active treatment
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 255
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 multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index \[CDAI\] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.

Detailed description: This is a multi-centre, double-blind, randomised, active treatment, parallel group study designed to induce clinical response and/or clinical remission with two oral doses of GSK1605786A (500 milligrams once daily, 500 milligrams twice daily) over a 12-week treatment period in subjects with moderately-to-severely active Crohn's disease. The primary objective of this study is to qualify subjects for enrolment into a follow up 52 week maintenance study CCX114157. Subjects who achieve induction of clinical response (CDAI decrease from baseline of at least 100 points) or remission (CDAI score less than 150) at Week 12 following treatment with GSK1605786A will be eligible for enrolment into the maintenance study CCX114157. Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission.

The study is planned to randomise approximately 900 subjects (450 subjects per group) with active Crohn's disease who have been diagnosed for at least 4 months, with documented history of disease in the small and/or large intestine, and characterised by a CDAI score between 220 to 450 (inclusive). Subjects will be required to have evidence of current active inflammation by elevated C-reactive protein (greater than the upper limit of normal of the highly sensitive C-reactive protein test) OR an elevated level of faecal calprotectin. Subjects will be allowed to participate in the study while continuing on stable doses of agents typically used to treat Crohn's disease. Inclusion of subjects who received prior treatment with an anti-tumor necrosis factor agent and discontinued due to loss or lack of efficacy will be limited to approximately 50 percent of the study population. Following a 3-week screening period, subjects will be randomised at baseline to receive blinded treatment with one of two doses of GSK1605786A (500 milligrams once daily or twice daily) for 12 weeks. All subjects meeting the definition of responder (CDAI decrease from baseline of at least 100 points) or who are in remission (CDAI score less than 150 points) at Week 12 will be eligible for randomisation into an ongoing maintenance study (CCX114157). Subjects who do not meet the definition of responder or who are not in remission at Week 12 will not be eligible to participate in study CCX114157.

For subjects who complete the study the minimum duration of participation is 15 weeks and the maximum duration is 19 weeks.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications
* Diagnosis of Crohn's disease for more than 4 months with small bowel and/or colonic involvement
* Current evidence of moderately-to-severely active disease defined by a baseline Crohn's Disease Activity Index (CDAI) score of 220 to 450, inclusive
* Confirmation of active disease by elevated CRP (greater than or equal to the upper limit of normal for the highly sensitive C-reactive protein test) or elevated levels of faecal calprotectin
* History of inadequate response and/or intolerance or adverse event leading to discontinuation of at least one of the following treatments for Crohn's disease: corticosteroids or immunosuppressants
* 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
* Female subjects of child-bearing potential are eligible if not pregnant or nursing and committed to use of contraceptive methods with a failure rate of less than 1 percent per year

Exclusion Criteria:

* Known coeliac disease, those who follow a gluten-free diet to manage symptoms of suspected coeliac disease and subjects with a positive screening test for coeliac disease (elevated anti-tissue transglutaminase antibodies)
* Diagnosis of ulcerative or indeterminate colitis
* Enterocutaneous, abdominal or pelvic fistulae with abscesses, or fistulae likely to require surgery during the course of the study period
* Bowel surgery, other than appendectomy, within 12 weeks prior to screening and/or has planned surgery or deemed likely to need surgery for Crohn's disease during the study period
* Extensive colonic resection, subtotal or total colectomy
* Presence of ileostomies, colostomies or rectal pouches
* Fixed symptomatic stenoses of small bowel or colon
* 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 medicaitons
* Use of prohibited medications, including enteral feeding or elemental diet, within their specified timeframes and throughout the study. Prohibited medications include the following:

  1. Biologic use: Use of any TNF inhibitor (such as infliximab, adalimumab or certolizumab) or natalizumab within 10 weeks prior to Randomisation
  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. Enteral feeding: Use of tube or enteral feeding, elemental diet within 2 weeks prior to Screening
  6. Rectal Treatment: Use of 5-aminosalicylates or corticosteroid enemas or suppositories within 2 weeks prior to Screening
  7. Leukocytapheresis or granulocytapheresis within 2 weeks prior to Screening
  8. Paracetamol or acetaminophen greater than 2 grams per day
  9. Opioid analgesics for worsening Crohn's disease pain are prohibited when used on a regular daily basis for more than 3 days
  10. Digoxin or related cardiac glycosides: Use within 7 days prior to Screening
  11. Any previous participation in a clinical study of GSK1605786A (formerly ChemoCentryx compound CCX282-B)
* Positive immunoassay for Clostridium difficile
* Known HIV infection
* Known varicella, herpes zoster, or other severe viral infection within 6 weeks of screening
* Immunization with a live vaccine within 4 weeks of Screening and throughout the study with the exception of the influenza vaccine
* Positive hepatitis B surface antigen or hepatitis B core antibody test or positive Hepatitis C test result at Screening
* Active or latent tuberculosis infection determined by results of QuantiFERON TB Gold test
* Current sepsis or infections requiring intravenous antibiotic therapy for more than 2 weeks
* Previous infections characterised by opportunistic pathogens, and/or dissemination suggestive of clinically significant immunocompromise
* Evidence of hepatic dysfunction, viral hepatitis, or abnormalities in liver function test results
* Corrected QT interval of ECG (electrocardiogram) greater than or equal to 450 milliseconds
* Congenital or acquired immunodeficiency or has evidence of immunocompromise manifested by current opportunistic infection
* 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)
* History of evidence of adenomatous colonic polyps that have not been removed.
* History of evidence of colonic mucosal dysplasia
* If female, is pregnant, has a positive pregnancy test or is breast-feeding
* Concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (such as an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematologic, or neurological condition or mental impairment)
* Medical history of sensitivity to any of the components of GSK1605786A (microcrystalline cellulose, crospovidone, sodium stearyl fumarate).
* Use of any investigational product within 30 days prior to screening

Primary outcomes:
measure: Percentage of Participants Achieving Clinical Response at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12
timeFrame: Week 8 and Week 12
measure: Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12
timeFrame: Both Week 8 and Week 12
measure: Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12
timeFrame: Baseline (Screening) and Weeks 4, 8, and Week 12
measure: Change From Baseline in Faecal Calprotectin at Week 12
timeFrame: Baseline (Screening) and Week 12
measure: Pharmacokinetics (PK) of GSK1605786A
timeFrame: Baseline (Screening) and Week 12
measure: Pharmacogenetic Analyses
timeFrame: Post randomization any time during early two 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: La Jolla
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facility: GSK Investigational Site
state: California
city: Aurora
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state: Colorado
city: Denver
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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
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facility: GSK Investigational Site
state: District of Columbia
city: Jacksonville
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state: Florida
city: Port Orange
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city: Suwanee
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facility: GSK Investigational Site
state: Georgia
city: Chicago
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facility: GSK Investigational Site
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city: Chevy Chase
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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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state: Massachusetts
city: Chesterfield
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state: Michigan
city: Rochester
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state: Minnesota
city: Lee's Summit
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city: Mexico
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city: Brooklyn
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state: New York
city: Lake Success
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facility: GSK Investigational Site
state: New York
city: Stony Brook
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facility: GSK Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
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facility: GSK Investigational Site
state: North Carolina
city: Charlotte
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facility: GSK Investigational Site
state: North Carolina
city: Columbus
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state: Ohio
city: Tulsa
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state: Oklahoma
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city: Pittsburgh
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state: Pennsylvania
city: Nashville
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state: Tennessee
city: Austin
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state: Texas
city: Ogden
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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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city: Richmond
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city: Madison
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city: Milwaukee
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city: Box Hill
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facility: GSK Investigational Site
state: Victoria
city: Fitzroy
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state: Victoria
city: Prahran
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facility: GSK Investigational Site
state: Victoria
city: Fremantle
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facility: GSK Investigational Site
state: Western Australia
city: Hall in Tirol
country: Austria
facility: GSK Investigational Site
city: Linz
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facility: GSK Investigational Site
city: Oberpullendorf
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city: St.Veit/Glan
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
facility: GSK Investigational Site
city: Wien
country: Austria
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city: Wien
country: Austria
facility: GSK Investigational Site
city: Bonheiden
country: Belgium
facility: GSK Investigational Site
city: Edegem
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
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Vina del Mar
country: Chile
facility: GSK Investigational Site
city: Hradec Králové
country: Czechia
facility: GSK Investigational Site
city: Olomouc
country: Czechia
facility: GSK Investigational Site
city: Praha 4
country: Czechia
facility: GSK Investigational Site
city: Praha 9
country: Czechia
facility: GSK Investigational Site
city: Teplice
country: Czechia
facility: GSK Investigational Site
city: Usti nad Orlici
country: Czechia
facility: GSK Investigational Site
city: Aalborg
country: Denmark
facility: GSK Investigational Site
city: Aarhus
country: Denmark
facility: GSK Investigational Site
city: Herlev
country: Denmark
facility: GSK Investigational Site
city: Koebenhavn NV
country: Denmark
facility: GSK Investigational Site
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: Paris cedex 10
country: France
facility: GSK Investigational Site
city: Saint-Priest en Jarez
country: France
facility: GSK Investigational Site
city: Heidelberg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Weiden
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Frankfurt am Main
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Brinkum/Stuhr
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Koeln
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Halle
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
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country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Jena
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Ioannina
country: Greece
facility: GSK Investigational Site
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
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Budapest
country: Hungary
facility: GSK Investigational Site
city: Debrecen
country: Hungary
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city: Mosonmagyaróvár
country: Hungary
facility: GSK Investigational Site
city: Szekszárd
country: Hungary
facility: GSK Investigational Site
city: Vác
country: Hungary
facility: GSK Investigational Site
city: Afula
country: Israel
facility: GSK Investigational Site
city: Beer Sheva
country: Israel
facility: GSK Investigational Site
city: Haifa
country: Israel
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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: 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
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Aichi
country: Japan
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city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
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city: Fukuoka
country: Japan
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city: Hiroshima
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
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city: Hyogo
country: Japan
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city: Kagoshima
country: Japan
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city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
city: Osaka
country: Japan
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city: Shizuoka
country: Japan
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city: Tokyo
country: Japan
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city: Wakayama
country: Japan
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Pusan
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: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: EDE
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
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city: Rotterdam
country: Netherlands
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city: Canterbury
country: New Zealand
facility: GSK Investigational Site
city: Dunedin
country: New Zealand
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city: Hamilton
country: New Zealand
facility: GSK Investigational Site
city: Lower Hutt
country: New Zealand
facility: GSK Investigational Site
city: Otahuhu
country: New Zealand
facility: GSK Investigational Site
city: Takapuna, 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
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city: Sopot
country: Poland
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city: Wroclaw
country: Poland
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country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Porto
country: Portugal
facility: GSK Investigational Site
city: Viseu
country: Portugal
facility: GSK Investigational Site
city: Irkutsk
country: Russian Federation
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: 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: Galdakao/Vizcaya
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: Bern
country: Switzerland
facility: GSK Investigational Site
city: Zürich
country: Switzerland
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
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: Glasgow
country: United Kingdom
facility: GSK Investigational Site
state: Lanarkshire
city: Harrow
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Dundee
country: United Kingdom
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: London
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
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: