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
Showing 1 - 6 of 235 Results
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
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