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Also known as Abrilumab
AMG 181 · 3 trials · 2 indications
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150 at week 8. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI 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 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 (Q4W) 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. |
| 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. |
| Placebo arm | ACTIVE_COMPARATOR | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
| Active arm | ACTIVE_COMPARATOR | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
| Name | Type | Description |
|---|---|---|
| Abrilumab | DRUG | Administered by subcutaneous injection. |
| Placebo | DRUG | Placebo matching to abrilumab administered by subcutaneous injection |
| AMG 181 | DRUG | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
| Placebo for AMG 181 | OTHER | Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease. |
Inclusion Criteria: * Diagnosed with ileal, ileo-colonic, or colonic Crohn's disease for a minimum of 6 months prior to baseline * Moderately to severely active Crohn's disease defined by a CDAI score ≥ 220 and ≤ 450 at baseline * Evidence of active inflammation within 12 weeks prior to baseline * ...
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AMG 181 is an investigational small molecule being developed for ulcerative colitis, a form of inflammatory bowel disease. It was studied in a Phase 1 clinical trial that also included patients with Crohn's disease, another inflammatory bowel condition. The drug is not approved and remains in clinical development.
AMG 181 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company sponsored a Phase 1 clinical trial of the drug in patients with ulcerative colitis and Crohn's disease.
AMG 181 is in Phase 1 clinical development. A Phase 1 study of the drug has been completed, and it is not approved for any use. The drug remains investigational, and no later-phase trials have been reported.
AMG 181 has one completed clinical trial, identified as NCT01290042, titled "Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181." This Phase 1 study enrolled 43 participants with ulcerative colitis or Crohn's disease, as well as healthy volunteers, at sites in the United States and Australia.
AMG 181 is the only name provided for this drug, and no alternative names have been reported. It is an investigational small molecule developed by Amgen Inc. for ulcerative colitis and Crohn's disease.