An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
Public ClinicalTrials.gov record NCT01536418. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomised, Double-blind, Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Moderately-to-Severely Active Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index \[CDAI\] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.
Study identification
- NCT ID
- NCT01536418
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 255 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 11, 2011 (Actual)
- Primary completion
- Oct 17, 2013 (Actual)
- Completion
- Oct 17, 2013 (Actual)
- Last update posted
- Jan 29, 2018
2011 – 2013
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arizona | 72205 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | La Jolla | California | 92037 | — |
| GSK Investigational Site | Aurora | Colorado | 80045 | — |
| GSK Investigational Site | Denver | Colorado | 80222 | — |
| GSK Investigational Site | Littleton | Colorado | 80120 | — |
| GSK Investigational Site | Hamden | Connecticut | 06518 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Jacksonville | Florida | 32256-6004 | — |
| GSK Investigational Site | Port Orange | Florida | 32127 | — |
| GSK Investigational Site | Suwanee | Georgia | 30024 | — |
| GSK Investigational Site | Chicago | Illinois | 60637 | — |
| GSK Investigational Site | Chevy Chase | Maryland | 20815 | — |
| GSK Investigational Site | Towson | Maryland | 21204 | — |
| GSK Investigational Site | Towson | Maryland | 21286 | — |
| GSK Investigational Site | Boston | Massachusetts | 02114 | — |
| GSK Investigational Site | Chesterfield | Michigan | 48047 | — |
| GSK Investigational Site | Rochester | Minnesota | 55905 | — |
| GSK Investigational Site | Lee's Summit | Missouri | 64064 | — |
| GSK Investigational Site | Mexico | Missouri | 65265-3726 | — |
| GSK Investigational Site | Brooklyn | New York | 11206 | — |
| GSK Investigational Site | Lake Success | New York | 11042 | — |
| GSK Investigational Site | Stony Brook | New York | 11794 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | — |
| GSK Investigational Site | Columbus | Ohio | 43215 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74135 | — |
| GSK Investigational Site | Portland | Oregon | 97225 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | — |
| GSK Investigational Site | Nashville | Tennessee | 37232 | — |
| GSK Investigational Site | Austin | Texas | 78745 | — |
| GSK Investigational Site | Ogden | Utah | 84405 | — |
| GSK Investigational Site | Christiansburg | Virginia | 24073 | — |
| GSK Investigational Site | Danville | Virginia | 24541 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Richmond | Virginia | 23249 | — |
| GSK Investigational Site | Madison | Wisconsin | 53792 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 187 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01536418, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2018 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01536418 live on ClinicalTrials.gov.