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 involved 359 people in total across five groups. Participants had ulcerative colitis and were given either a placebo (a dummy treatment) or one of four different doses of a drug called abrilumab. The trial was measuring how many people in each group reached certain milestones at 8 weeks, including "remission" (meaning their disease activity score dropped to a very low level on a standard rating scale) and "response" (meaning their score improved by a meaningful amount). It also looked at "mucosal healing" (whether the lining of the bowel appeared healthier on examination) and whether remission was maintained through to week 24. The reported data shows the following results at the 8-week mark for the primary goal — the percentage of participants in remission. In the placebo group, around 4.3% were in remission. For the abrilumab groups, the figures were: 0% (7 mg dose), 2.5% (21 mg dose), 13.3% (70 mg dose), and 12.7% (210 mg dose). For the secondary measure of "response" at week 8, the reported figures were 25.9% (placebo), 14.3% (7 mg), 50.0% (21 mg), 49.0% (70 mg), and 46.8% (210 mg). For mucosal healing at week 8, the figures were 21.6% (placebo), 14.3% (7 mg), 15.0% (21 mg), 32.7% (70 mg), and 29.1% (210 mg). The reported data also shows the percentage of participants who remained in remission at both week 8 and week 24 (called "sustained remission"): 2.6% for placebo, 0% (7 mg), 2.5% (21 mg), 8.2% (70 mg), and 3.8% (210 mg). All figures above reflect the raw, unadjusted numbers as submitted; adjusted figures (accounting for other factors) were also reported and were broadly similar. 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 30472236) ↗
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, 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 have been diagnosed with ulcerative colitis (UC) for at least 3 months, confirmed by a camera examination of the bowel and a tissue sample.
- Your UC is considered moderate to severe, based on specific scoring measurements taken before the study begins.
- You have not responded well to, stopped responding to, or could not tolerate at least one of the following treatments: immune-suppressing medications, anti-TNF medications, or steroids (steroid eligibility may depend on your country — confirm with trial site).
- You have had a neurological (brain and nerve) check-up during screening that showed no unexplained or significant concerns.
Who may not be able to join:
- Your UC is only in the very last part of the bowel, closest to the back passage (within about 4 inches).
- You have a serious bowel complication called toxic megacolon (a severely swollen colon).
- You have Crohn's disease instead of, or as well as, UC.
- You have previously had major bowel surgery, such as removal of part or all of the colon, or have a stoma or internal pouch.
- You are planning to have bowel surgery within 6 months of the study start.
- A stool test at screening came back positive for a harmful gut infection called C. difficile.
- You have had any gastrointestinal (digestive system) surgery within 8 weeks before the study starts.
- You have a liver condition called Primary Sclerosing Cholangitis.
- You have any serious or uncontrolled ongoing illness affecting other parts of your body.
- Your doctor believes your health condition could put you at risk or interfere with the study (confirm with trial site).
- You have tested positive for Hepatitis B, Hepatitis C, or HIV.
- You have an underlying condition that makes you more likely to get infections, such as uncontrolled diabetes or a previous removal of your spleen.
- You have had a problem with drug or alcohol misuse in the past year.
- You have had a cancer diagnosis in the past 5 years (some minor skin cancers or fully treated cervical cancer may be exceptions — confirm with trial site).
- You have taken certain immune-suppressing medications (cyclosporine A, tacrolimus, or mycophenolate mofetil) within the past month.
- You have used anti-TNF medications within the past 2 months (or longer, depending on the specific medication — confirm with trial site).
- You have ever been treated with vedolizumab, rituximab, efalizumab, or natalizumab.
- You have used rectal (inserted into the back passage) aminosalicylic acid or rectal steroids in the past 2 weeks.
- You have received steroid injections or infusions (into a vein or muscle) within the past 2 weeks before or during screening.
- You have previously been treated with the study drug AMG 181.
- You have received a live vaccine (such as MMR or yellow fever) within the past month, or plan to receive one during the study.
- You have recently taken antibiotics, antiviral, or antifungal medicines (by mouth within 14 days, or by drip/infusion within 30 days before the study starts).
- Your blood or urine test results at screening came back abnormal.
- You are currently taking part in another clinical trial, or finished one less than 30 days ago.
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 With Remission at Week 8
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.