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 looked at a medicine called brodalumab in people with Crohn's disease, a condition causing ongoing inflammation in the digestive tract. A total of 130 people took part, split into four groups: 32 received a placebo (a dummy treatment with no active medicine), 32 received brodalumab at 210 mg, 33 at 350 mg, and 33 at 700 mg. The main thing the trial was measuring was how many people in each group reached what is called "clinical remission" — meaning their disease activity score (measured using a tool called the CDAI, which rates symptoms like abdominal pain, bowel habits and general wellbeing on a scale of 0 to 600) dropped to 150 points or below by week 6. The reported data shows that for the primary goal of reaching remission at week 6, the percentages were: 3.1% in the placebo group, 3.1% in the 210 mg brodalumab group, 15.2% in the 350 mg group, and 9.1% in the 700 mg group. For one of the secondary measures — whether participants' CDAI score fell by at least 100 points from their starting level — the reported figures were 12.5% (placebo), 16.1% (210 mg), 27.3% (350 mg), and 15.2% (700 mg). When looking at the average change in CDAI score from the start of the trial to week 6, all groups showed some decrease (a negative number meaning lower disease activity scores), with the placebo group changing by −28.2 points, the 210 mg group by −8.7 points, the 350 mg group by −35.4 points, and the 700 mg group by −0.6 points. The reported data also shows that the number of participants who experienced at least one adverse event (an unwanted medical occurrence during the trial) was 25 in the placebo group, 23 in the 210 mg group, 27 in the 350 mg group, and 28 in the 700 mg group, though no deaths were recorded in any 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 2 Crohn's Disease and Colitis 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:
- You have been diagnosed with Crohn's disease affecting the small intestine, large intestine, or both, for at least 6 months before starting the study medication
- Your Crohn's disease is considered moderately to severely active, based on a specific disease activity score (called a CDAI score) measured at the start of the study
- There is clear evidence that active inflammation is present in your body
Who may not be able to join:
- You have short bowel syndrome (a condition where part of the small intestine is missing or not working)
- You have had a bowel blockage with symptoms in the last 3 months
- You have had bowel surgery in the last 3 months
- You have an ileostomy or colostomy (a surgically created opening in the abdomen for waste removal)
- You have any surgically created pouch in your stomach or intestines
- You have ulcerative colitis rather than Crohn's disease
- You have an infected abscess (a pocket of infection) in your body
- You have had a bowel perforation (a hole in the bowel) or a non-inflammatory bowel blockage in the last 6 months
- A stool test at screening showed a harmful bacterial infection called C. difficile
- You currently have an active infection that requires treatment
- You have had a serious infection within the last 8 weeks
- You have other significant medical conditions (confirm with trial site)
- You are pregnant or breastfeeding
- Your recent blood or lab tests showed significant abnormalities (confirm with trial site)
- You have taken any anti-TNF medication (a type of immune-suppressing drug) within the last 2 months
- You have used steroid enemas within the last 2 weeks
- You have taken Tysabri (natalizumab) within the last year
- You have received certain other biologic medications (such as ustekinumab), taken part in experimental treatments, or received a live vaccine within the last 3 months
- You have taken certain immune-suppressing medications, including cyclosporine, mycophenolate mofetil, sirolimus, thalidomide, or tacrolimus, within the last 2 months
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
Percentage of Participants Who Achieved Clinical Remission at Week 6
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.