GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease (SHIELD-2)

This study has been terminated.
(This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01316939
First received: March 3, 2011
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: GSK1605786A
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Remission (CDAI score less than 150 points) [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
    Proportion of subjects in clinical remission (CDAI score less than 150 points)


Secondary Outcome Measures:
  • Corticosteroid-free remission [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
    Proportion of subjects in clinical remission (CDAI score less than 150 points) and not taking corticosteroids

  • Remission in subjects who were in remission at baseline [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
    Proportion of subjects in clinical remission (CDAI score less than 150 points) in subjects who were in remission at baseline

  • Remission at end of treatment [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Proportion of subject in clinical remission (CDAI score less than 150 points) at end of treatment

  • Clinical response (CDAI decrease of at least 100 points) [ Time Frame: At both Weeks 28 and 52 ] [ Designated as safety issue: No ]
    Proportion of subjects with clinical response (CDAI decrease of at least 100 points)

  • Induction of remission in subjects who were not in remission at baseline [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Time to induction of remission in subjects who were not in remission at baseline

  • Change from baseline in CDAI score [ Time Frame: Weeks 4, 8, 12, 20, 28, 36, 44, 52 ] [ Designated as safety issue: No ]
    Change from baseline in CDAI score at various timepoints over the treatment period

  • Safety outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in safety measures and incidence of adverse events and serious adverse events

  • Health outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in quality of life measures

  • Biomarkers [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Change from baseline in C-reactive protein and faecal calprotectin


Enrollment: 229
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Experimental: GSK1605786A
500 milligrams once daily or twice daily
Drug: GSK1605786A
GSK1605786A 500 milligrams once daily
Drug: GSK1605786A
GSK1605786A 500 milligrams twice daily

Detailed Description:

This is a multi-centre, randomised, placebo-controlled, double-blind parallel group study in adult subjects with Crohn's disease who previously achieved clinical response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior Phase III induction study (Study CCX114151 or another GSK sponsored induction study). Subjects will be randomised to 52 weeks of oral treatment with GSK1605786A 500 mg once daily or 500 mg twice daily or placebo. Subjects who are receiving concomitant corticosteroids at entry will undergo dose tapering following a defined schedule. Subjects who complete the treatment period may be eligible to enter an open-label extension study. Subjects who experience disease worsening and require additional (rescue) treatment will be withdrawn and may be eligible to enter the open-label study. Subjects who do not enter the open-label study must complete a follow-up assessment 4 weeks after completion of treatment. Approximately 756 subjects will be enrolled.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316939

  Show 256 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01316939     History of Changes
Other Study ID Numbers: 114157, 2010-022383-12
Study First Received: March 3, 2011
Last Updated: March 13, 2014
Health Authority: Australia: Human Research Ethics Committee
Canada: Health Canada
Belgium: Federal Agency for Medicines and Health Products, FAMHP
United States: Food and Drug Administration
Norway: Norwegian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
Denmark: Danish Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Sweden: Medical Products Agency
Europe: European Medicines Agency

Keywords provided by GlaxoSmithKline:
Crohn's disease, oral CCR9 antagonist, placebo-controlled, maintenance of remission, 52-week treatment, quality of life

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 30, 2014