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 (NCT03283085) looked at a medicine called ontamalimab in people with two types of inflammatory bowel disease: ulcerative colitis (UC) and Crohn's disease (CD). A total of 557 people started the trial across six groups, receiving either a 25 mg dose, a 75 mg dose, or starting on 25 mg and then moving up to 75 mg. The trial's main focus was on monitoring participants for any medical events or changes in their health during treatment — including any unwanted medical occurrences, serious infections, blood test results, heart tracings (ECG), and measurements like blood pressure and temperature. The reported data shows that when it came to unwanted medical events that occurred during treatment, the numbers varied across groups. In the ulcerative colitis groups, 67 out of 89 participants (25 mg group), 122 out of 159 (25 mg then 75 mg group), and 203 out of 268 (75 mg group) experienced such events. In the Crohn's disease groups, the numbers were 4 out of 5, 8 out of 10, and 17 out of 26 respectively. For serious infections — meaning those that were life-threatening or needed hospital care or intravenous antibiotics — the reported data shows 5, 4, and 17 participants across the three UC groups, and zero participants in each of the three CD groups. For blood test changes, heart tracing changes, and vital sign changes, the reported data shows zero participants recorded with notable changes across all six groups. As a secondary measure, the number of UC participants recorded as having a treatment response (defined as a meaningful reduction in a combined score of bleeding and stool frequency) was reported as 116 in the 25 mg then 75 mg group and 129 in the 75 mg group. 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, Completed
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
If you have Ulcerative Colitis (UC):
- You (or your parent or legal representative) are willing and able to fully follow all study rules and procedures.
- You (or your parent or legal representative) are able to give written, signed, and dated consent to take part in the study.
- You previously took part in specific earlier studies (SHP647-301 or SHP647-302) and then the maintenance study (SHP647-303), and your UC symptoms improved with the study drug (ontamalimab) during those studies (confirm with trial site for specific response measures).
- Any UC medications you are currently taking have been at a stable, unchanged dose for the required period of time.
If you have Crohn's Disease (CD):
- You (or your parent or legal representative) are willing and able to fully follow all study rules and procedures.
- You (or your parent or legal representative) are able to give written, signed, and dated consent to take part in the study.
- You previously took part in specific earlier studies (SHP647-305 or SHP647-306) and then the maintenance study (SHP647-307), and your CD symptoms improved with the study drug (ontamalimab) during those studies (confirm with trial site for specific response measures).
- Any CD medications you are currently taking have been at a stable, unchanged dose for the required period of time.
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.
If you have Ulcerative Colitis (UC):
- You seriously broke the rules of one of the earlier related studies, as decided by the study sponsor.
- You had to permanently stop taking the study drug because of a side effect in one of the earlier related studies.
- Your doctors think you are likely to need major surgery for your UC.
- You are a woman who became pregnant during one of the earlier related studies, are currently breastfeeding, are planning to become pregnant during this study, or you (male or female) are unwilling to use appropriate birth control throughout the study.
- You are unwilling to avoid donating organs, tissues, sperm, or eggs for the entire duration of the study and for 16 weeks after your last dose of the study drug.
- In the opinion of the study doctor or sponsor, you are unlikely to follow the study procedures.
- You have been newly diagnosed with cancer, or a previous cancer has come back (with some exceptions for certain treated skin or cervical cancers — confirm with trial site).
- You have developed a significant new illness or unstable health condition affecting organs such as the kidneys, liver, heart, or lungs, or you have an active infection that the study doctor believes would put you at risk.
- You have any other serious medical or psychiatric condition, or abnormal test results, that the study doctor believes would make it unsafe or unsuitable for you to participate.
- You have been exposed to tuberculosis (TB) since your screening tests in the earlier related studies, and you need treatment for TB but do not have an accepted treatment plan available.
- You are a member of staff at the study site, a relative of a staff member, or a sponsor employee directly involved in running this study.
- You are currently taking part in another clinical trial (other than the specific related studies listed) or plan to join another clinical trial during this study.
If you have Crohn's Disease (CD):
- You seriously broke the rules of one of the earlier related studies, as decided by the study sponsor.
- You had to permanently stop taking the study drug because of a side effect in one of the earlier related studies.
- Your doctors think you are likely to need major surgery for your CD, or you have had a serious sudden complication of CD requiring urgent treatment, or your disease activity score is very high (confirm with trial site).
- You are a woman who became pregnant during one of the earlier related studies, are currently breastfeeding, are planning to become pregnant during this study, or you (male or female) are unwilling to use appropriate birth control throughout the study.
- You are unwilling to avoid donating organs, tissues, sperm, or eggs for the entire duration of the study and for 16 weeks after your last dose of the study drug.
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 7 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 (TEAEs); Number of Participants With Serious Infections; Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time; Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time; Number of Participants With Discernible Changes in Vital Signs Over Time
Other options
Data last synced from ClinicalTrials.gov: 6 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.