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 (NCT02641392) involved three groups of participants who received different doses or schedules of a drug called GED-0301: 4 people received a 40 mg alternating schedule, 13 received a standard 40 mg dose, and 293 received a 160 mg alternating schedule — giving a total of 310 participants. The trial ran for up to 208 weeks (roughly four years). Notably, the reported data shows that none of the participants in any group were recorded as having completed the study — all participants were listed under "not completed." The primary outcome the trial measured was the number of participants who experienced treatment-emergent adverse events (that is, any unwanted health event that happened during or shortly after treatment). The reported data shows that in the 160 mg alternating schedule group — the largest group with 293 participants — 189 people experienced some form of adverse event during the study period. Of those, 43 experienced a serious adverse event (meaning one that led to hospitalisation, was life-threatening, or had another significant medical consequence), 38 experienced a severe adverse event (meaning symptoms causing severe discomfort or pain), and 41 experienced an event in a fourth category, though the label for that category was not clearly specified in the data. In the smaller groups, the numbers were much lower, which is consistent with those groups having far fewer participants. No additional outcome measures beyond this adverse event count were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
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
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 are 18 years of age or older (for adult participants)
- You previously took part in a specific related clinical study called GED-0301-CD-002 or GED-0301-CD-003
- You are willing and able to use an approved method of contraception as required by the study
- You are between 12 and 17 years old (for adolescent participants)
- As an adolescent, you previously took part in the specific related clinical study called GED-0301-CD-003
- As an adolescent, you are able to swallow tablets
- As an adolescent, you are willing and able to use an approved method of contraception as required by 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.
- You had a serious side effect related to the study medication during your participation in the previous related clinical study
- You have recently started taking certain biological medicines, such as TNF-alpha blockers or integrin antagonists (confirm with trial site)
- You are currently pregnant or breastfeeding
- You have developed a known allergy or sensitivity to the study drug or any of its ingredients
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.
Trial contact details on record
Principal Investigator: Guillermo Rossiter, MD, Celgene
Australian sites
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
Where this trial was run
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
Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208
Other options
Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.