Approval Probability
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Also known as AMG 181
Abrilumab · 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 * ...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
Abrilumab was studied for the treatment of moderate to severe Crohn's disease and moderate to severe ulcerative colitis, two inflammatory bowel diseases. It is an investigational monoclonal antibody developed by Amgen Inc. and has been evaluated in Phase 2 clinical trials in adults aged 18 years and older.
Abrilumab targets the integrins ITGA4 and ITGB7, acting as an inhibitor of these targets. By binding these integrin subunits, the monoclonal antibody is designed to interfere with the integrin-mediated pathways involved in the inflammatory processes underlying Crohn's disease and ulcerative colitis.
Abrilumab is being developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen sponsored the Phase 2 clinical trials of abrilumab, also known as AMG 181, in Crohn's disease and ulcerative colitis.
Abrilumab is in Phase 2 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. The completed Phase 2 trials evaluated abrilumab in adults with moderate to severe Crohn's disease and moderate to severe ulcerative colitis.
Abrilumab has been studied in two completed Phase 2 trials: NCT01696396 in adults with moderate to severe Crohn's disease, which enrolled 254 participants, and NCT01694485 in adults with moderate to severe ulcerative colitis, which enrolled 359 participants. Both were randomized, double-blind, placebo-controlled trials conducted across multiple countries.
Yes, abrilumab is also known as AMG 181. The two names refer to the same investigational monoclonal antibody developed by Amgen Inc. The Phase 2 trials in Crohn's disease and ulcerative colitis were conducted under the AMG 181 designation.