Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01694485 | Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis | PHASE2 | COMPLETED | 359 | — | — | Nov 16, 2012 | Apr 10, 2018 | Jun 27, 2019 | 123 | United States, Australia +18 |
Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted remission rate).
| Arm | Type | Description |
|---|---|---|
| Placebo Q4W/Abrilumab 210 mg Q3M | PLACEBO_COMPARATOR | Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Abrilumab 7 mg Q4W/Abrilumab 210 mg Q3M | EXPERIMENTAL | Participants received 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M | EXPERIMENTAL | Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M | EXPERIMENTAL | Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Abrilumab 210 mg/Abrilumab 210 mg Q3M | EXPERIMENTAL | Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24. During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks. |
| Name | Type | Description |
|---|---|---|
| Abrilumab | BIOLOGICAL | Administered by subcutaneous injection. |
| Placebo | DRUG | Placebo matching to abrilumab administered by subcutaneous injection |
Inclusion Criteria: * Diagnosis of ulcerative colitis (UC) established ≥ 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report. * Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy scor...