Last updated: 11/07/2018 07:19:54
GSK1605786A in the Maintenance of Remission in Subjects with Crohn's DiseaseSHIELD-2
EudraCT ID
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: A 52 week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects with Crohn’s Disease
Trial description: 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 in maintaining remission over 52 weeks in adult subjects with Crohn’s disease. Efficacy will be assessed by the Crohn’s Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment – Crohn’s Disease (WPAI-CD) and disability.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage of participants in clinical remission (Crohn’s Disease Activity Index , CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period
Timeframe: Week 28 and 52
Secondary outcomes:
Percentage of participants in clinical remission (CDAI score <150 points) and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period
Timeframe: Week 28 and 52
Percentage of participants in clinical remission at both Weeks 28 and 52 of the 52-week treatment period among those participants who were in clinical remission at Baseline
Timeframe: Week 28 and 52
Percentage of participants in clinical remission at all visits (continuous clinical remission) during the 52-week treatment period among participants in clinical remission at Baseline
Timeframe: Upto Week 52
Percentage of participants in clinical remission at Week 52
Timeframe: Week 52
Percentage of participants with a clinical response (CDAI decrease >=100 points) at both Weeks 28 and 52 of the 52-week treatment period
Timeframe: Week 28 and 52
Time to induction of clinical remission in participants who had achieved clinical response during induction therapy but were not in clinical remission at Baseline
Timeframe: Upto Week 52
Change from Baseline in CDAI score at Weeks 4, 8, 12, 20, 28, 36, 44, and 52
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, and 52
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 52
Timeframe: Baseline (Week 0) and Week 52
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Upto 56 weeks
Change from Baseline in vital sign systolic blood pressure systolic (SBP) and diastolic blood pressure (DBP) upto Week 56
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52, 56
Change from Baseline in vital sign heart rate upto Week 56
Timeframe: Baseline (Week 0) and Weeks 4, 8, 12, 20, 28, 36, 44, 52 and 56
Number of participants with shift from Baseline in hematology parameters
Timeframe: Upto Week 56
Number of participants with shift from Baseline in clinical chemistry parameters
Timeframe: Upto Week 56
Change from Baseline in liver function test parameter total bilirubin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.
Timeframe: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 and 56.
Change from Baseline in liver function test parameter albumin at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Timeframe: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Change from Baseline in liver function test parameter alanine amino transferase, aspartate amino transferase, alkaline phosphatase and gamma glutamyl transferase at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Timeframe: Baseline (Week 0) and Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Number of participants with 12 lead electocardiogram (ECG) abnormalities at Week 28 and 52
Timeframe: Week 28 and 52
Change from Baseline in Short Form – 36 version 2 (SF-36 v2) at Weeks 28 and 52
Timeframe: Baseline (Week 0) and Weeks 28 and 52
Change from Baseline in European Quality of Life (EuroQol ) five dimensions questionnaire (EQ-5D) at Weeks 28 and 52
Timeframe: Baseline (Week 0) and Weeks 28 and 52
Change from Baseline in Work productivity & activity impairment – Crohn’s disease (WPAI-CD) at Weeks 28 and 52
Timeframe: Baseline (Week 0) and Weeks 28 and 52
Receipt of disability benefits at Weeks 28 and 52
Timeframe: Weeks 28 and 52
Change from Baseline in health-related resource utilization at Weeks 28 and 52
Timeframe: Baseline (Week 0) and Weeks 28 and 52
Change from Baseline in C reactive protein (CRP) at Weeks 28 and 52
Timeframe: Baseline (Week 0 and Weeks 28 and 52
Change from Baseline in faecal calprotectin at Weeks 28 and 52
Timeframe: Baseline (Week 0) and Weeks 28 and 52
Interventions:
Enrollment:
229
Primary completion date:
2013-23-10
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)
May 2011 to October 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Subjects achieving clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study
- Written informed consent prior to any CCX114157 specific study procedures
- If female, is pregnant, has a positive pregnancy test or is breast-feeding
- Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects achieving clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study
- Written informed consent prior to any CCX114157 specific study procedures
- Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of less than 1 percent
- Stable doses of Crohn's disease medications
- Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose taper during the study
Exclusion criteria:
- If female, is pregnant, has a positive pregnancy test or is breast-feeding
- Subjects with known or suspected coeliac disease or a positive screening test (anti-tissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti-tissue transglutaminase antibodies prior to enrolment into the maintenance study.
- Known or suspected fixed symptomatic small bowel stricture
- Enterocutaneous, abdominal or pelvic fistulae likely to require surgery during the study period
- Current sepsis or infections requiring intravenous antibiotic therapy for greater than 2 weeks
- Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities
Trial location(s)
Location
GSK Investigational Site
Mexico, Missouri, United States, 65265-3726
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bankstown, New South Wales, Australia, 2200
Status
Study Complete
Showing 1 - 6 of 247 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
2013-23-10
Actual study completion date
2013-23-10
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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