Phase 3 Crohn's Disease and Colitis Trial, TerminatedNCT02596893Sponsor: CelgeneCondition: Crohn's Disease and Colitis
Printed from Voxsanity (voxsanity.com.au) — NCT02596893 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
This trial is terminated. It is no longer accepting participants. See the expanded access section below for other pathways.
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 (NCT02596893) enrolled 701 adults with Crohn's disease across four groups: a placebo group (174 people) and three groups receiving different dosing regimens of a drug called GED-0301 (approximately 175–176 people each). The trial ran for up to 52 weeks and was measuring things like how many participants reached "clinical remission" (a standard scoring system dropping below a threshold that indicates low disease activity), how many had a meaningful improvement in symptoms ("clinical response"), and how many showed improvement on internal camera examination of the bowel. It is worth noting that very few participants completed the full double-blind 52-week period in any group — between 8 and 14 out of roughly 175 in each group.
The reported data shows that at week 52, the percentage of participants reaching clinical remission was 5.3% in the placebo group, 2.5%, 9.4%, and 3.4% in the three GED-0301 groups respectively. For improvement seen on bowel camera examination at week 52, the figures were 3.5% (placebo), 0.8%, 1.6%, and 1.7% across the GED-0301 groups. At the earlier four-week mark, between roughly 15–20% of participants in every group — including placebo — had reached the remission threshold, and around 28–34% across all groups had shown a meaningful symptom improvement score. The reported data shows similarly small differences between groups at week 12 for symptom response (placebo 44.4%; GED-0301 groups 32–34%). For the measure of being in remission without using corticosteroids at week 52, figures ranged from 0.0% to 7.0% across the GED-0301 groups, compared with 2.2% for placebo.
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
NCT02596893
TerminatedPhase 3🇦🇺 Australian site
Who may 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 might be able to join this trial:
You are 18 years of age or older (male or female)
You have been diagnosed with active Crohn's disease, confirmed by specific scoring tests used by doctors to measure disease activity and gut inflammation
You have a minimum number of daily bowel movements or a certain level of abdominal pain on most days over a 7-day period (confirm exact numbers with trial site)
You have already tried at least one Crohn's disease treatment — such as certain steroids, immune-suppressing medicines, or biologic medicines — and it either did not work well enough for you or you had problems tolerating it
Who may not be able to join:
You have been diagnosed with a different type of bowel condition, such as ulcerative colitis, ischemic colitis, microscopic colitis, radiation colitis, or colitis related to diverticular disease
You have serious complications of Crohn's disease such as significant narrowing of the bowel, abscesses (pockets of infection), or very short bowel syndrome, or other complications that might need surgery
You have had bowel surgery within the last 6 months, or any abdominal surgery within the last 3 months before the screening visit
You have a stoma bag (ileostomy or colostomy)
You have another significant health condition that, in the doctor's opinion, would make it unsafe or unsuitable for you to take part in the study
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 5 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Guillermo Rossiter, MD, Celgene Corporation
Australian sites
Bankstown-Lidcombe Hospital, Bankstown, Australian Capital Territory
Royal Prince Alfred Hospital, Camperdown, New South Wales
Concord Repatriation General Hospital, Concord, New South Wales
Centre For Digestive Diseases, Five Dock, New South Wales
Liverpool Hospital, Liverpool, New South Wales
Mater Adult Hospital, South Brisbane, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland
Royal Adelaide Hospital, Adelaide, South Australia
Flinders Medical Centre, Bedford Park, South Australia
Box Hill Hospital, Box Hill, Victoria
The Alfred Hospital, Melbourne, Victoria
Fiona Stanley Hospital, Murdoch, Western Australia
Ballarat Base Hospital, Ballarat,
Monash Medical Centre Clayton, Bentleigh East,
St Vincents Hospital Melbourne, Fitzroy,
Austin Hospital, Heidelberg,
Royal Brisbane and Women's Hospital, Herston,
Nepean Hospital, Kingswood, NSW,
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:
Trial: NCT02596893
Sponsor: Celgene
Phase: Phase 3
Status: Terminated
Condition: Crohn's Disease and Colitis
More information: https://clinicaltrials.gov/study/NCT02596893
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
You are 18 years of age or older (male or female)
You have been diagnosed with active Crohn's disease, confirmed by specific scoring tests used by doctors to measure disease activity and gut inflammation
You have a minimum number of daily bowel movements or a certain level of abdominal pain on most days over a 7-day period (confirm exact numbers with trial site)
You have already tried at least one Crohn's disease treatment — such as certain steroids, immune-suppressing medicines, or biologic medicines — and it either did not work well enough for you or you had problems tolerating it
Who may not be able to join:
You have been diagnosed with a different type of bowel condition, such as ulcerative colitis, ischemic colitis, microscopic colitis, radiation colitis, or colitis related to diverticular disease
You have serious complications of Crohn's disease such as significant narrowing of the bowel, abscesses (pockets of infection), or very short bowel syndrome, or other complications that might need surgery
You have had bowel surgery within the last 6 months, or any abdominal surgery within the last 3 months before the screening visit
You have a stoma bag (ileostomy or colostomy)
You have another significant health condition that, in the doctor's opinion, would make it unsafe or unsuitable for you to take part in the study
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 5 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Terminated
Phase
Phase 3
Sponsor
Celgene
Registry
ClinicalTrials.gov
Start date
8 December 2015
Est. completion
5 January 2018
Where this trial is recruiting
🇦🇺 Australia
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇦 Canada
🇭🇷 Croatia
🇨🇿 Czechia
🇩🇰 Denmark
🇪🇪 Estonia
🇫🇮 Finland
🇫🇷 France
🇩🇪 Germany
🇬🇷 Greece
🇭🇺 Hungary
🇮🇱 Israel
🇮🇹 Italy
🇱🇻 Latvia
🇲🇾 Malaysia
🇳🇱 Netherlands
🇳🇿 New Zealand
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇷🇺 Russia
🇷🇸 Serbia
🇸🇰 Slovakia
🇰🇷 South Korea
🇪🇸 Spain
🇸🇪 Sweden
🇨🇭 Switzerland
Turkey (Türkiye)
🇺🇦 Ukraine
🇬🇧 United Kingdom
🇺🇸 United States
18 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
The Percentage of Participants Who Achieved a Clinical Remission at Week 12
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 5 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.