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 enrolled 67 people in total across four groups. Each group received a different dosing arrangement of brodalumab (an investigational medicine) or a placebo, with most participants later switching to a standard dose of brodalumab. The trial was measuring undesirable medical events that occurred during treatment, changes in disease activity scores for Crohn's disease (a condition causing ongoing gut inflammation), and whether participants' scores crossed thresholds defined as a meaningful response or remission. The reported data shows that when it came to undesirable medical events during the study, between 8 and 18 participants in each group experienced at least one such event, and between 2 and 5 in each group experienced a serious event (meaning one that was severe enough to require hospitalisation or met similar serious criteria). No deaths were reported. For the disease activity score — called the CDAI, where lower numbers mean less active disease — the reported data shows that the percentage of participants whose score dropped by 100 points or more (considered a meaningful response) ranged from around 21% to 55% depending on the group and the time point measured. The percentage reaching what was defined as remission (a score of 150 or below) ranged from 0% to about 33% across groups and time points. The reported data also shows that no participant in any group developed antibodies (immune proteins) against the study medicine. It is worth noting that the structured results list zero completions across all groups, which may reflect how the study's phases were recorded rather than meaning no one finished. These figures describe what was measured and counted — they do not on their own tell us whether any difference between groups was meaningful or due to 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 ↗
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 2 Irritable Bowel Syndrome Trial, Terminated
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:
- People who were enrolled in the related earlier study (NCT01150890) and completed their Week 12 check-up in that study.
- People whose Week 12 check-up in the earlier study took place no more than 1 year before the planned start date in this trial.
- The person joining, or their legal representative, must have given written consent to participate.
- People who are up to date with the vaccinations recommended in their region (for example, those recommended by the US Centers for Disease Control and Prevention for participants in the US).
- For people where 3 months or more have passed since their Week 12 visit in the earlier study: if the study doctor feels it is medically appropriate (for example, due to a known recent exposure), test results must show no active hepatitis B, hepatitis C, or HIV infection.
- For women where 4 weeks or less have passed since their Week 12 visit in the earlier study: a urine pregnancy test taken just before the first dose must show a negative result (this does not apply to women who have been through menopause for at least 2 years or who have had a surgical procedure making pregnancy impossible).
- For women where more than 4 weeks have passed since their Week 12 visit in the earlier study: a blood pregnancy test taken within 28 days before starting the trial drug, and a urine pregnancy test just before the first dose, must both show negative results (this does not apply to women who have been through menopause for at least 2 years or who have had a surgical procedure making pregnancy impossible).
- For people where 3 months or more have passed since their Week 12 visit, if the study doctor considers it necessary: people who previously had a negative tuberculosis (TB) skin test must have a new negative TB skin test within 30 days before the planned first dose; people who previously had a positive TB skin test must have a negative result on a different TB blood test (called a QuantiFERON test) within 30 days before the planned first dose.
Who may not be able to join:
- People who had a serious side effect during the earlier study that was considered to be related to the study drug.
- People who had a side effect or abnormal test result during the earlier study that the study doctor believes could make continuing treatment harmful, prevent them from finishing the study, or affect the reliability of the results.
- People who are known to be allergic or sensitive to any of the products used in this trial.
- People who currently have an active infection that requires prescription oral medication or stronger treatment (eligibility may be reconsidered once the infection has cleared).
- People who had a serious infection requiring hospital admission or intravenous (drip) antibiotics within the 8 weeks before the planned first dose.
- For people where 3 months or more have passed since their Week 12 visit: people who have had 3 or more infections requiring antibiotic or antiviral treatment in the past 12 months.
- People with certain significant ongoing health conditions, including: Type 1 diabetes; uncontrolled Type 2 diabetes; moderate to severe heart failure; a heart attack within the past year; unstable chest pain (angina) within the past year; uncontrolled high blood pressure (confirmed resting blood pressure of 150/90 mmHg or above); severe long-term lung disease requiring oxygen; a major long-term inflammatory or autoimmune condition other than Crohn's disease (such as lupus, rheumatoid arthritis, or psoriasis); or active cancer, including certain skin cancers.
- People with a history of cancer, except for successfully treated early-stage cervical cancer or certain treated skin cancers (basal cell or squamous cell carcinoma).
- People who have any other condition that, in the study doctor's opinion, could make participation harmful.
- For people where more than 4 weeks have passed since their Week 12 visit: people whose screening blood tests show certain abnormal results, including elevated liver enzymes, abnormal bilirubin levels, low haemoglobin (less than 10 g/dL), high blood sugar control marker (HbA1c above 8.0 in people with Type 2 diabetes), low platelet count, low white blood cell count, low neutrophil count (a type of immune cell), or reduced kidney function. Any other abnormal blood test result that the study doctor believes could make participation unsafe or affect the study results would also be a reason for exclusion.
- People who have used the medication natalizumab (Tysabri) since completing the earlier study.
- People who have received a type of medication called an anti-TNF agent within 8 weeks before the planned first dose.
- People who have received another commercially available biologic medicine (such as ustekinumab) within 12 weeks before the planned first dose.
- People who have taken part in another investigational (experimental) drug or device study, or received an experimental treatment (other than the study drug AMG 827), since completing the earlier study.
- People who have received a live vaccine within 12 weeks before the planned first dose.
- People who have taken certain immune-suppressing medications — including cyclosporine, mycophenolate mofetil, sirolimus, thalidomide, or tacrolimus — within 4 weeks before the planned first dose.
- Women who are not willing or able to use highly effective contraception during the trial (unless they have been through menopause for at least 2 years or have had a surgical procedure making pregnancy impossible).
- Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
- People who have a condition that, in the study doctor's opinion, may affect their ability to give informed consent or follow all study requirements.
- People who will not be available to attend all required study visits.
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: MD, Amgen
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Treatment-emergent Adverse Events (TEAEs); Percentage of Participants Who Achieved a CDAI Response; Percentage of Participants Who Achieved Clinical Remission
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.