Phase 3 Crohn's Disease and Colitis Trial, Terminated NCT01316939 Sponsor: GlaxoSmithKline Condition: Crohn's Disease and Colitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 229 people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. Participants were divided into three groups: 76 received a placebo (a dummy treatment with no active ingredient), 77 received the investigational medicine GSK1605786A at 500 mg once a day, and 76 received the same medicine at 500 mg twice a day. The trial ran for 52 weeks and was primarily measuring how many people achieved "clinical remission" — meaning their Crohn's disease symptom score (called the CDAI) dropped below a set threshold — at both the 28-week and 52-week points. It is worth noting that a large number of participants in each group did not complete the study, and the trial was ended early. The reported data shows that for the main outcome — the percentage of participants reaching remission at both weeks 28 and 52 — the placebo group had the highest figure at 10.5%, compared to 6.5% in the once-daily medicine group and 3.9% in the twice-daily medicine group. For a secondary outcome looking at remission while also not taking corticosteroids (a type of anti-inflammatory medicine) at those same time points, the reported figures were 9.2% for placebo, 5.2% for once-daily, and 3.9% for twice-daily. Several other planned secondary outcomes — including remission at week 52 alone, continuous remission, and clinical response — were not reported with numbers, with the trial record noting that the early termination of the study meant there was insufficient data to draw conclusions from those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Crohn's Disease and Colitis Trial, Terminated

NCT01316939
Terminated Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You must have already taken part in a related induction study (Study CCX114151 or another GSK-sponsored study) and shown improvement in your Crohn's disease symptoms or reached remission during that study
  • You must be willing and able to sign a consent form before any procedures in this study begin
  • If you are a woman who could become pregnant, you must either not be sexually active or agree to use a reliable form of contraception that has less than a 1% chance of failing
  • Any medications you are already taking for Crohn's disease must be at a stable, unchanged dose
  • If you are currently taking steroid medications, you must be willing to gradually reduce your steroid dose during the study

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • Women who are pregnant, who test positive for pregnancy, or who are breastfeeding
  • People who are known or suspected to have coeliac disease, or who test positive for a related antibody — this will need to be checked with a blood test before joining (confirm with trial site)
  • People who have a known or suspected blockage in the small bowel that is causing symptoms
  • People who have certain types of abnormal connections or tunnels between the bowel and the skin or other nearby areas that are likely to need surgery during the study
  • People who currently have a serious infection or blood poisoning that requires intravenous (drip) antibiotics for more than 2 weeks
  • People who have signs of liver problems, liver disease, or a hepatitis (liver) infection

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026

Trial contact details on record

Principal Investigator: GSK Clinical Trials, GlaxoSmithKline

Australian sites

GSK Investigational Site, Bankstown, New South Wales
GSK Investigational Site, Hersten, Queensland
GSK Investigational Site, Adelaide, South Australia
GSK Investigational Site, Kurralta Park, South Australia
GSK Investigational Site, Box Hill, Victoria
GSK Investigational Site, Fitzroy, Victoria
GSK Investigational Site, Prahran, Victoria
GSK Investigational Site, Fremantle, Western Australia

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
9 May 2011
Est. completion
23 October 2013

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇺 Russia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 8 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

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

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov