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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022383-12-NL

Enrollment

750

Registered

2010-10-29

Start date

2011-02-16

Completion date

Unknown

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with Crohn's Disease MedDRA version: 16.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Product Name: GSK1605786A Product Code: GSK1605786A Pharmaceutical Form: Capsule, hard INN or Proposed INN: GSK1605786A CAS Number: na Current Sponsor code: GSK1605786A Other descriptive name: na Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects achieving clinical response (CDAI decrease = 100points) and/or remission (CDAI =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1. If female, is pregnant, has a positive pregnancy test or is breast-feeding 2. Subjects with known or suspected coeliac disease or a positive screening test (antitissue transglutaminase (anti-tTG) antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should be tested for anti-tTG antibodies and excluded or withdrawn from study upon positive result 3 Fixed symptomatic stenoses of small bowel or colon. 4. Enterocutaneous , abdominal or pelvic fistulae likely to require surgery during the study period 5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks 6. Use of prohibited medications at baseline and throughout the study (Section 5.5.3 of the protocol). 7. The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (SGPT) and/or AST (SGOT) values =2 times the upper limit of normal; has a total bilirubin value >1.5 times the upper limit of normal (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH); has known hepatic or biliary abnormalities with the exception of Gilbert’s syndrome or asymptomatic gallstones Note: At randomisation into the study, liver function tests results from the final visit in the preceding induction study will not be available . Subjects who have abnormalities as per the exclusion above will need to be withdrawn.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: • To evaluate the safety of GSK1605786A compared with placebo • To investigate the effect of GSK1605786A compared with placebo on health-related quality of life • To investigate the effect of GSK1605786A compared with placebo on health-related resource utilisation • To investigate the effect of GSK1605786A compared with placebo on work productivity and activity impairment • To investigate the effect of GSK1605786A compared with placebo on unemployment and disability rates • To investigate the effect of GSK1605786A compared with placebo on biomarkers of inflammation [C-reactive protein (CRP) and faecal calprotectin] • To explore the dose relationships between GSK1605786A plasma concentration and Clinical response endpoints;Main Objective: • To assess the efficacy of GSK1605786A compared with placebo in maintaining clinical remission in subjects with Crohn’s disease over 52 weeks.;Primary end point(s): Primary Efficacy endpoints: Proportion of subjects in clinical remission (CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period Safety Endpoints: • Incidence of adverse events/serious adverse events • Change from baseline in vital signs: heart rate and blood pressure • Change from baseline in haematology and clinical chemistry parameters • Change from baseline in liver function test parameters • Change from baseline in 12 lead ECG abnormalities;Timepoint(s) of evaluation of this end point: Safety assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study. 12 lead ECG at Week 0, 28, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study. CDAI assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.	—

Measure

Time frame

Secondary Objective: • To evaluate the safety of GSK1605786A compared with placebo • To investigate the effect of GSK1605786A compared with placebo on health-related quality of life • To investigate the effect of GSK1605786A compared with placebo on health-related resource utilisation • To investigate the effect of GSK1605786A compared with placebo on work productivity and activity impairment • To investigate the effect of GSK1605786A compared with placebo on unemployment and disability rates • To investigate the effect of GSK1605786A compared with placebo on biomarkers of inflammation [C-reactive protein (CRP) and faecal calprotectin] • To explore the dose relationships between GSK1605786A plasma concentration and Clinical response endpoints;Main Objective: • To assess the efficacy of GSK1605786A compared with placebo in maintaining clinical remission in subjects with Crohn’s disease over 52 weeks.;Primary end point(s): Primary Efficacy endpoints: Proportion of subjects in clinical remission (CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period Safety Endpoints: • Incidence of adverse events/serious adverse events • Change from baseline in vital signs: heart rate and blood pressure • Change from baseline in haematology and clinical chemistry parameters • Change from baseline in liver function test parameters • Change from baseline in 12 lead ECG abnormalities;Timepoint(s) of evaluation of this end point: Safety assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study. 12 lead ECG at Week 0, 28, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study. CDAI assessments at Week 0, 4, 8, 12, 20, 28, 36, 44, 52 and post 4 week follow-up at Week 56, if subject does not enrol in follow on study.

—

Secondary

Measure	Time frame
Secondary end point(s): Key Secondary efficacy endpoint: Proportion of subjects in clinical remission (CDAI score <150 points) and not taking corticosteroids at both Weeks 28 and 52 of the 52-week treatment period;Timepoint(s) of evaluation of this end point: Weeks 28 and 52	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactClincial Trials HelpDesk

GlaxoSmithKline Research & Development Ltd

GSKClincialSupportHD@gsk.com+44208990 44 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026