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 (NCT04173273) tested a medicine called etrasimod, given at two different doses (2 mg and 3 mg), compared to a placebo (a dummy treatment with no active ingredient). The trial was conducted across several sub-studies, involving different groups of participants at different stages — an initial treatment period, an extended treatment period, and a longer-term maintenance phase. In total, across all sub-studies and groups, several hundred participants took part. The largest single sub-study (SS1) began with 100 people on placebo, 98 on etrasimod 2 mg, and 97 on etrasimod 3 mg during the induction (initial) period. A smaller sub-study (SSA) started with 1 person on placebo, 42 on etrasimod 2 mg, and 41 on etrasimod 3 mg. Additional groups continued into extended and maintenance phases, with numbers ranging from small groups of around 12–47 participants depending on the sub-study. The reported data shows that in the main induction period (SS1), 87 of the 100 placebo participants, 89 of the 98 on etrasimod 2 mg, and 81 of the 97 on etrasimod 3 mg completed that phase. In the smaller SSA sub-study, 1 of 1 placebo, 32 of 42 on etrasimod 2 mg, and 36 of 41 on etrasimod 3 mg completed the induction period. In the longer-term maintenance phase (SS3), the reported data shows that of those who had responded to treatment and continued, completion numbers varied by group — for example, 29 of 38 completed in one etrasimod 2 mg group, and 17 of 28 in one etrasimod 3 mg group. The reported data shows that outcome measure numbers for the primary and secondary endpoints themselves were not included in the structured data provided, and therefore those specific results cannot be described here. 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 ↗ · Read the linked publication on PubMed (PMID 39575597) ↗
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 a man or woman between 18 and 80 years old
- You are able to give written consent and are able to follow the schedule of visits and assessments required by the trial
- You have been diagnosed with Crohn's disease for at least 3 months
- Your Crohn's disease is considered moderately to severely active at the time of screening
- You have tried at least one of the following treatments and either did not respond to it, stopped responding over time, or could not tolerate it: steroid tablets (such as prednisone or budesonide), immune-suppressing medicines (such as azathioprine, 6-mercaptopurine, or methotrexate), or certain biologic injection/infusion treatments (such as infliximab, adalimumab, certolizumab, vedolizumab, or ustekinumab)
- If you are a woman who could become pregnant, you must not currently be pregnant
- If you are a woman who could become pregnant, or a man, you must agree to use contraception during the trial
- For Substudy 3: You must have previously participated in and completed a specific visit during the extended induction period of Substudy 1 or Substudy 2 (confirm with trial site)
- For Substudy 4: You must have completed a specific week 52 or week 66 visit in an earlier part of the trial (confirm with trial site)
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 not responded to two or more different classes of biologic treatments (such as TNF-blockers, interleukin blockers, or integrin blockers) for Crohn's disease
- You have another type of bowel condition, such as ulcerative colitis, microscopic colitis, ischemic colitis, toxic megacolon, or an active bowel infection, or you test positive for a bacteria called Clostridioides difficile at screening
- You have short bowel syndrome or related complications that may need surgery or affect how the trial measures results
- You had surgery to treat an abscess inside your abdomen within the last 8 weeks, or surgery for an abscess near your back passage within the last 4 weeks
- You had a portion of your intestine removed within the last 24 weeks, or any other abdominal surgery within the last 12 weeks
- You have a stoma bag (ileostomy or colostomy)
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: Pfizer CT.gov Call Center, Pfizer
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 17 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 With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA; Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1; Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort; Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort; Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Responder Cohort; Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Non-Responder Cohort
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.