Last updated: 11/07/2018 08:06:01
Open-Label Extension Study of GSK1605786ASHIELD-3
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects with Crohn’s Disease
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with any adverse events (AE) and any serious adverse events (SAE)
Timeframe: Up to Week 112
Secondary outcomes:
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
Change from Baseline (Week 0) in heart rate (HR) over period
Timeframe: Baseline (week 0) and up to Week 112
Number of participants with shifts from Baseline (Week 0) for the indicated hematology parameters
Timeframe: Baseline (Week 0) and up to Week 112
Number of participants with shifts from Baseline (Week 0) for the indicated clinical chemistry parameters
Timeframe: Baseline (Week 0) and up to Week 112
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
Change from Baseline (Week 0) in total bilirubin
Timeframe: Baseline (Week 0) and up to Week 112
Change from Baseline (Week 0) in albumin
Timeframe: Baseline (Week 0) and up to Week 112
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)
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
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
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
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
Interventions:
Enrollment:
399
Primary completion date:
2013-29-10
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)
April 2011 to October 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Previous participation in a GSK-sponsored study with GSK1605786A
- Written informed consent prior to any study-specific procedures
- 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
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Seattle, Washington, United States, 98195
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342-5006
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Hammond, Louisiana, United States, 70403
Status
Study Complete
Location
GSK Investigational Site
Aurora, Colorado, United States, 80045
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Brooklyn, New York, United States, 11206
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Setauket, New York, United States, 11733-9292
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chesterfield, Michigan, United States, 48047
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
Location
GSK Investigational Site
Port Orange, Florida, United States, 32127
Status
Study Complete
Location
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Vitkovice, Czech Republic, 70384
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32256-6004
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Danville, Virginia, United States, 24541
Status
Study Complete
Location
GSK Investigational Site
Suwanee, Georgia, United States, 30024
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Littleton, Colorado, United States, 80120
Status
Study Complete
Location
GSK Investigational Site
Lee's Summit, Missouri, United States, 64064
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0298
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nizhniy Novgorod, Russia, 603126
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23502
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Fuenlabrada (Madrid), Spain, 28942
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20007
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97225
Status
Study Complete
Location
GSK Investigational Site
Germantown, Tennessee, United States, 38138
Status
Study Complete
Location
GSK Investigational Site
Lake Success, New York, United States, 11042
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80215
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Christiansburg, Virginia, United States, 24073
Status
Study Complete
Location
GSK Investigational Site
Mexico, Missouri, United States, 65265-3726
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212-1610
Status
Study Complete
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109-5682
Status
Study Complete
Location
GSK Investigational Site
Sabadell (Barcelona), Spain, 08208
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Abbotsford, British Columbia, Canada, V2S 3N5
Status
Study Complete
Location
GSK Investigational Site
Chevy Chase, Maryland, United States, 20815
Status
Study Complete
Location
GSK Investigational Site
Hamden, Connecticut, United States, 06518
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85712
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Towson, Maryland, United States, 21204
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32423
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92093
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 2K5
Status
Study Complete
Location
GSK Investigational Site
Kurralta Park, South Australia, Australia, 5037
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Haven, Connecticut, United States, 06510
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Little Rock, Arizona, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Monroe, Louisiana, United States, 71201
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98101
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Study Complete
Location
GSK Investigational Site
Newcastle-upon-Tyne, United Kingdom, NE1 4LP
Status
Study Complete
Location
GSK Investigational Site
Nove Mesto nad Vahom, Slovakia, 915 01
Status
Terminated/Withdrawn
Location
GSK Investigational Site
South Towson, Maryland, United States, 21286
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Shatin, New Territories, Hong Kong
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rochester, Minnesota, United States, 55905
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599-7080
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Study Complete
Location
GSK Investigational Site
Hradec Králové, Czech Republic, 500 12
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt am Main, Hessen, Germany, 60590
Status
Study Complete
Location
GSK Investigational Site
Bankstown, New South Wales, Australia, 2200
Status
Study Complete
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
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
Other
Actual primary completion date
2013-29-10
Actual study completion date
2013-29-10
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
Participate in clinical trial
Access to clinical trial data by researchers
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