Last updated: 11/07/2018 07:17:10
A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects with Moderately-to-Severely Active Crohn's DiseaseSHIELD-1
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with Crohn’s Disease Activity Index (CDAI) response at Week 12
Timeframe: Week 12
Secondary outcomes:
Percentage of participants with CDAI Remission at Week 12
Timeframe: Week 12
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
Percentage of participants achieving clinical remission (CDAI <150 points) at both Week 8 and Week 12
Timeframe: Week 8 and 12
Percentage of Participants with a clinical response (CDAI decrease from baseline of >=100 points) at Week 8
Timeframe: Week 8
Percentage of participant achieving clinical remission (CDAI <150 points) at Week 8
Timeframe: Week 8
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
Incidence of adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to Week 12
Interventions:
Enrollment:
608
Primary completion date:
2013-11-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
B. G. Feagan, W. Sandborn, G. D’Haens, S. Lee, M. Allez, R. Fedorak, U. Seidler, S. Vermeire, I. Lawrance, A. Maroney, C. H. Jurgensen, A. Heath, D. J. Chang.Randomised clinical trial: vercirnon, an oral CCR9 antagonist, vs. placebo as induction therapy in active Crohn's disease.Aliment Pharmacol Ther.2015;42(10):1170–1181.
Medical condition
Crohn's Disease
Product
vercirnon
Collaborators
Not applicable
Study date(s)
December 2010 to July 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Male or female subjects aged 18 years or older
- Written informed consent
- 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
Inclusion and exclusion 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 a. Biologic use: Use of any biologic (tumour necrosis factor inhibitor or natalizumab) within 8 weeks prior to screening b. Corticosteroid use: Use of parenteral glucocorticoids within 4 weeks prior to screening c. Immunospressant use: Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks prior to screening d. Intravenous antibiotic use: Use of intravenous antibiotics for Crohn’s disease within 4 weeks prior to screening e. Use of rectal treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks prior to screening f. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening g. 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
Trial location(s)
Location
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
Status
Study Complete
Location
GSK Investigational Site
Richmond Hill, Ontario, Canada, L4B 3P8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Study Complete
Location
GSK Investigational Site
Newcastle-upon-Tyne, United Kingdom, NE1 4LP
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Vitkovice, Czech Republic, 70384
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3M9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98101
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67067
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Study Complete
Location
GSK Investigational Site
Maitland, Florida, United States, 32751
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32207
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2K5
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
Status
Study Complete
Location
GSK Investigational Site
Abbotsford, British Columbia, Canada, V2S 3N5
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0298
Status
Study Complete
Location
GSK Investigational Site
Bankstown, New South Wales, Australia, 2200
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
Status
Study Complete
Location
GSK Investigational Site
Port Orange, Florida, United States, 32127
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hradec Králové, Czech Republic, 500 12
Status
Study Complete
Location
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Towson, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-5048
Status
Study Complete
Location
GSK Investigational Site
Dessau, Sachsen-Anhalt, Germany, 06847
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
Status
Study Complete
Location
GSK Investigational Site
Monroe, Louisiana, United States, 71201
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
Status
Study Complete
Location
GSK Investigational Site
Littleton, Colorado, United States, 80120
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97225
Status
Study Complete
Location
GSK Investigational Site
Braunschweig, Niedersachsen, Germany, 38126
Status
Study Complete
Location
GSK Investigational Site
Nove Mesto nad Vahom, Slovakia, 915 01
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, Texas, United States, 77034-0550
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
Location
GSK Investigational Site
SanDiego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32256-6004
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Hammond, Louisiana, United States, 70403
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Oak Lawn, Illinois, United States, 60453
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80215
Status
Study Complete
Location
GSK Investigational Site
Nottingham, United Kingdom, NG7 2UH
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32423
Status
Study Complete
Location
GSK Investigational Site
Hamden, Connecticut, United States, 06518
Status
Study Complete
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60590
Status
Study Complete
Location
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Brinkum/Stuhr, Niedersachsen, Germany, 28816
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Michigan, United States, 48047
Status
Study Complete
Location
GSK Investigational Site
Kurralta Park, South Australia, Australia, 5037
Status
Study Complete
Location
GSK Investigational Site
Lee's Summit, Missouri, United States, 64064
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342-5006
Status
Study Complete
Location
GSK Investigational Site
Egg Harbor Township, New Jersey, United States, 08234
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arizona, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90015
Status
Study Complete
Location
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212-1610
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-11-07
Actual study completion date
2013-11-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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