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 (NCT03290781) enrolled 366 people across seven groups to study a medicine called ontamalimab (ONTA) in people with ulcerative colitis — a condition causing inflammation in the large bowel. Participants were assigned to receive either a lower dose (25 mg) or higher dose (75 mg) of ONTA, or a placebo (a dummy treatment with no active ingredient), across two back-to-back periods of the study. The trial measured whether participants reached "remission" — meaning their symptoms and bowel-lining appearance had improved to near-normal levels — by week 52. Not all participants who started the study completed it; completion numbers varied considerably across the groups. The reported data shows the following number of participants who met the main goal of remission at week 52, based on a combined score of symptoms and a camera examination of the bowel: 6 out of 73 people who received the 25 mg dose followed by placebo; 38 out of 71 who received 25 mg in both periods; 11 out of 86 who received the 75 mg dose followed by placebo; and 33 out of 82 who received 75 mg in both periods. For the secondary (additional) measures — which looked at things like bowel lining appearance alone, symptom scores alone, sustained remission, overall response, and a combined measure of bowel lining and tissue health — the reported numbers followed a similar pattern, with consistently higher counts in the groups that continued receiving ONTA into the second period compared with those who switched to placebo. For example, for the combined bowel lining and tissue health measure, 37 participants in the 25 mg/25 mg group and 29 in the 75 mg/75 mg group met the threshold, compared with 6 and 11 respectively in the groups that switched to 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.
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, Completed
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 (or your parent or legal representative) must be willing and able to follow all study rules and attend all required visits.
- You must be able to give your written, signed, and dated agreement to take part in the study (either yourself or through a legal representative).
- You must have already completed the full 12-week treatment period in one of the two related earlier studies (NCT03259334 or NCT03259308).
- You must have shown a meaningful improvement in your ulcerative colitis symptoms and bowel examination results during those earlier studies, based on specific scoring measurements (confirm with trial site for exact details).
- If you are already taking any medications for ulcerative colitis, you must have been on a steady, unchanged dose for a set period of time and be expected to stay on that same dose.
Who may not be able to join:
- You seriously broke important rules of the earlier studies (as decided by the study sponsor).
- You had to permanently stop taking the study treatment in the earlier studies because of a side effect or health problem.
- The doctors think you are likely to need surgery for your ulcerative colitis during this study.
- You are a woman who became pregnant during the earlier studies, are planning to become pregnant during this study, or you (male or female) are not willing to use an appropriate form of birth control throughout the study.
- You are not willing to avoid donating organs, tissues, sperm, or eggs for the entire study period and for 16 weeks after your last dose of the study treatment.
- The doctor or sponsor believes you would be unable or unwilling to follow the study procedures.
- You have been newly diagnosed with cancer, or a previous cancer has come back (with some exceptions for certain minor skin or cervical conditions — confirm with trial site).
- You have developed a serious new illness or have an unstable health condition affecting organs such as the kidneys, liver, heart, or lungs, or you have an active infection, that the doctor believes would put you at too much risk.
- You have any other serious physical or mental health condition, or abnormal test results, that the doctor feels would make it unsafe or unsuitable for you to take part.
- You have been exposed to tuberculosis (TB) since your screening tests in the earlier studies and have not received an accepted course of treatment for it.
- You are a staff member 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, or planning to join, any other clinical trial during this study (other than the two related earlier studies).
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.
Contact this trial
Principal Investigator: Study Director, Shire
Australian sites
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.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Remission Based on Composite Score at Week 52
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.