Phase 3 Crohn's Disease and Colitis Trial, Terminated NCT03464097 Sponsor: Celgene Condition: Crohn's Disease and Colitis
Back to Crohns Disease And Colitis

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 involved 550 people with Crohn's disease — a condition causing inflammation in the digestive tract. Participants were split into three groups: 188 people who received the study drug ozanimod throughout the trial, 188 who received ozanimod for the first part then switched to a dummy pill (placebo), and 174 who received a placebo the whole time. The trial measured things like disease activity scores, signs of inflammation seen on camera (endoscopy), stomach pain, and bowel habits, mainly at the 52-week (one-year) mark. It is worth noting that a notable number of participants did not complete the study — roughly half in each group. The reported data shows the following for the main measures at week 52. For the first primary outcome — the proportion of participants whose overall disease activity score (a combined measure called CDAI) fell into a low-activity range — 44.2% of those on ozanimod throughout reached that level, compared with 33.1% of those who switched to placebo, and 35.5% of those always on placebo. For the second primary outcome — the proportion whose gut inflammation as seen on camera reduced by at least half from the start — the figures were 24.3%, 17.5%, and 16.4% respectively. For several secondary measures, including combined stomach pain and bowel frequency targets, and disease activity scores while off steroid medicines, the reported percentages ranged from roughly 32% to 51% depending on the group and the specific measure. 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

NCT03464097
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 met the requirements to join the earlier part of this study (called the "induction study") and completed all required assessments at the 12-week mark.
  • At week 12 of the induction study, you were showing improvement or were in remission, meaning your symptoms — such as number of bowel movements per day and abdominal pain — were well-controlled and no worse than when you started.

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.

  • You have had surgery to remove part or all of your large bowel, part of your small bowel, or have had a stoma (an opening created in the abdomen for waste) since the start of the induction study, or you have developed a new fistula (an abnormal tunnel connecting organs).
  • You have recently received certain treatments, including steroid suppositories or enemas, rectal anti-inflammatory medicines (called 5-aminosalicylates), steroid injections or infusions, immune-suppressing drugs, experimental treatments, or a blood-filtering treatment called apheresis (confirm with trial site for exact timing details).

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

For more information about this Bristol-Myers Squibb study, you can also visit: www.BMSStudyConnect.com

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 27 July 2026

Trial contact details on record

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Local Institution - 310, Concord, New South Wales
Local Institution - 319, Kingswood, New South Wales
Local Institution - 309, Liverpool, New South Wales
Local Institution - 318, New Lambton Heights, New South Wales
Local Institution - 323, Wollongong, New South Wales
Local Institution - 328, Herston, Queensland
Local Institution - 707, Maroochydore, Queensland
Local Institution - 313, Maroorchydore, Queensland
Local Institution - 321, North Mackay, Queensland
Local Institution - 312, South Brisbane, Queensland
Local Institution - 311, Woolloongabba, Queensland
Local Institution - 308, Adelaide, South Australia
Local Institution - 708, Adelaide, South Australia
Local Institution - 307, Bedford Park, South Australia
Local Institution - 326, Elizabeth Vale, South Australia
Local Institution - 320, Woodville South, South Australia
Local Institution - 317, Clayton, Victoria
Local Institution - 305, Fitzroy, Victoria
Local Institution - 329, Geelong, Victoria
Local Institution - 327, Melbourne, Victoria
Local Institution - 709, Melbourne, Victoria
Local Institution - 316, Murdoch, Western Australia
Local Institution - 315, Subiaco, Western Australia
Local Institution - 325, Bankstown,
Local Institution - 330, Box Hill,
Local Institution - 324, Sydney, NSW,

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
27 June 2018
Est. completion
3 October 2024

Where this trial was run

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria Belarus 🇧🇪 Belgium Bosnia and Herzegovina 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇭🇷 Croatia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇬🇪 Georgia 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇳 India 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇲🇽 Mexico Moldova 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇸🇦 Saudi Arabia Senegal 🇷🇸 Serbia 🇸🇰 Slovakia 🇸🇮 Slovenia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 26 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 Who Achieve Crohn's Disease Activity Index (CDAI) Score < 150 at Week 52 as Observed; Percentage of Participants With a Simple Endoscopic Score for Crohn's Disease (SES-CD) Score Decrease From Baseline ≥ 50% Based on Observed Cases and Robarts Observed Scores

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: 27 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