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 (NCT03559517) enrolled 29 people with Crohn's disease across three groups: 8 received a placebo (a dummy treatment with no active ingredient), 9 received a lower dose of ontamalimab (25 mg), and 12 received a higher dose (75 mg). The trial was measuring two main things at the 16-week mark: whether participants reached "clinical remission" based on their own daily reports of abdominal pain and stool frequency, and whether a camera examination of the bowel (endoscopy) showed a meaningful reduction in signs of disease activity. A number of secondary measures were also tracked, including remission based on a standard Crohn's disease scoring tool and broader definitions of response to treatment. The reported data shows the following numbers for the two primary measures at Week 16. For clinical remission based on participants' own daily symptom reports (pain and stool type): 1 out of 8 placebo participants, 2 out of 9 in the 25 mg group, and 1 out of 12 in the 75 mg group met this definition. For endoscopic response (a 25% or greater reduction in bowel inflammation score seen on camera): 3 out of 8 placebo participants, 4 out of 9 in the 25 mg group, and 5 out of 12 in the 75 mg group met this definition. For the secondary measures, the reported data shows similar small numbers across groups — for example, remission based on the standard Crohn's disease scoring tool was reached by 3, 4, and 3 participants in the placebo, 25 mg, and 75 mg groups respectively, and the broadest measure of clinical response (improvement in either pain or stool frequency) was reported in 4, 8, and 6 participants across the same groups. It is worth noting that this was a very small trial, with fewer than 30 people in total, which limits what can be drawn from the raw numbers alone. The reported data shows counts of participants meeting each definition — it does not on its own indicate whether any differences between groups are meaningful beyond chance. 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 38096402) ↗
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
- People aged 16 to 80 years old (those under 18 must weigh at least 40 kg and have a body mass index of at least 16.5)
- People who have active moderate to severe Crohn's disease (CD) affecting the lower small intestine, the junction between the small and large intestine, or the colon, confirmed by specific symptom scores and a colonoscopy showing ulcers characteristic of CD
- People who have had a confirmed CD diagnosis — backed by a tissue biopsy and colonoscopy report — for at least 3 months before joining the study
- People who are willing and able to undergo a colonoscopy during the screening period
- People whose CD has not responded well to, or who could not tolerate, at least one standard treatment such as sulfasalazine, mesalamine, steroids, immunosuppressants (such as azathioprine, mercaptopurine, or methotrexate), or anti-TNF medications
- People currently taking CD medications may be considered eligible, provided the dose has been stable for a set period of time and is expected to remain stable (confirm with trial site)
- Male participants, or female participants who are not pregnant and not breastfeeding; those who are sexually active must agree to use appropriate contraception for the duration of 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.
- People diagnosed with a different type of colitis, such as indeterminate colitis, microscopic colitis, medication-related colitis, colitis caused by reduced blood flow or infection, or whose test results suggest ulcerative colitis rather than CD
- People who have abnormal or precancerous cell changes in the colon (those with a past history of adenomatous polyps that have been fully removed may still be considered eligible)
- People with a history of, or currently having, a dangerous condition called toxic megacolon (a severe swelling of the large intestine)
- People who have an abnormal connection between the bowel and the bladder, or between the bowel and the vagina
- People with currently symptomatic diverticulitis or diverticulosis (inflammation or pouches in the bowel wall causing symptoms)
- People with a significant bowel narrowing causing a blockage, those who have had bowel surgery within the 6 months before screening, those likely to need surgery for CD during the study, or those who have had previous colon removal leaving less than 25 cm of colon remaining
- People with a history of multiple small bowel removals that have led to significant short bowel syndrome
- People who require feeding directly into a vein (total parenteral nutrition)
- People who have had bowel surgery resulting in a stoma (an opening in the abdomen for waste), or who have had a j-pouch procedure
- People who have previously been treated with the study drug, ontamalimab (also known as PF-00547659 or SHP647)
- People with a known or suspected allergy or intolerance to the study drug or any of its ingredients
- People who have taken certain immune-modifying medications (other than azathioprine, mercaptopurine, or methotrexate) or continuous antibiotics for more than 2 weeks for CD within 30 days before the baseline visit
- People who have received anti-TNF treatment within 60 days before the baseline visit
- People who have received any other immune-modifying biologic medication (other than anti-TNFs) within 90 days before the baseline visit
- People who have ever received any anti-integrin or anti-adhesion molecule treatment, such as natalizumab, vedolizumab, efalizumab, or etrolizumab
- People who have had a blood-filtering procedure (lymphocyte or monocyte granulocyte apheresis) within 60 days before the baseline visit
- People who have received tube feeding (enteral nutrition) within 30 days before the baseline visit
- People who have received steroids given directly into the bowel or by injection, or mesalamine given rectally, within 14 days before the screening colonoscopy
- People taking high doses of oral steroids above specified thresholds within certain time periods before the baseline visit (confirm exact dose limits with trial site)
- People who have taken part in another clinical trial within 30 days, or within 5 half-lives of the other trial's medication — whichever is longer — before screening
- People who have received a live or weakened vaccine within 30 days before the baseline visit
- People with active gut infections, C. difficile infection, cytomegalovirus, Listeria, active invasive fungal infections, parasitic infections, a medical condition that increases infection risk, or a serious infection requiring hospital treatment or intravenous antibiotics within 4 weeks before the baseline visit
- People with abnormal chest imaging at screening, such as signs of active tuberculosis (TB), significant infection, heart failure, or cancer
- People with active or latent TB who have not completed a full recognised course of treatment before the baseline visit; all other participants must have had specific TB screening tests (confirm details with trial site)
- People who test positive for TB during screening (using a skin test or blood test), unless they meet specific conditions set out in the protocol (confirm with trial site)
- People with a pre-existing nerve or brain condition such as multiple sclerosis, new seizures, unexplained changes in sensation, movement, thinking, or behaviour, or significant abnormalities found during screening
- People with any unexplained symptoms that may suggest a rare but serious brain condition called PML, identified during the screening neurological assessment
- People who have received an organ transplant (skin grafts for a specific skin condition called pyoderma gangrenosum are allowed)
- People with significant other medical conditions at the time of screening or baseline, including unstable major illnesses, cancer or a history of cancer within the past 5 years (with limited exceptions for certain skin or cervical cancers), a recent heart attack or unstable chest pain within 24 weeks before screening, or a significant stroke or brain blood vessel event within 24 weeks before screening
- People who have had major surgery or serious physical trauma within 4 weeks before screening, or who have major elective surgery planned during the study period
- People with liver cirrhosis (with or without complications) or primary sclerosing cholangitis (a liver and bile duct condition)
- People who test positive for hepatitis B surface antigen; those who test positive for hepatitis B core antibody may still be considered eligible if further testing shows no active hepatitis B virus (confirm with trial site)
- People with chronic hepatitis C infection (those who have cleared the virus or been successfully treated may still be considered eligible — confirm with trial site)
- People with certain abnormal blood or liver test results at screening, including liver enzyme levels, bilirubin, haemoglobin, platelet count, white blood cell count, neutrophil count, or kidney function outside of the specified ranges (confirm specific values with trial site)
- People with a known HIV infection, or those who test positive for HIV during screening
- People who have, or have had within the past 2 years, a serious psychiatric condition, alcohol dependency, or drug or substance misuse of any kind, including medicinal cannabis
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: Study Director, Shire
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 6 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 Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16; Number of Participants With Endoscopic Response at Week 16
Other options
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.