Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abrilumab · 2 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. |
| Name | Type | Description |
|---|---|---|
| Abrilumab | DRUG | Administered by subcutaneous injection. |
| Placebo | DRUG | Placebo matching to abrilumab administered by subcutaneous injection |
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 * ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Abrilumab is an investigational small molecule being developed for the treatment of ulcerative colitis and Crohn's disease, both of which are inflammatory bowel conditions. It has been studied in adults with moderate to severe forms of these diseases, though it remains in clinical development and is not yet approved.
Abrilumab is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company has conducted clinical trials to evaluate the drug's safety and efficacy in patients with ulcerative colitis and Crohn's disease.
Abrilumab is in Phase 2 clinical development. It has completed Phase 2 trials in both ulcerative colitis and Crohn's disease. As an investigational drug, it is not yet approved by regulatory authorities and continues to undergo evaluation in clinical studies.
Abrilumab has completed two Phase 2 clinical trials. The first, NCT01694485, studied the drug in 359 adults with moderate to severe ulcerative colitis. The second, NCT01696396, enrolled 254 adults with moderate to severe Crohn's disease. Both trials were randomized, double-blind, and placebo-controlled.
Yes, Abrilumab is also known as AMG 181. The clinical trials for this drug, including NCT01694485 and NCT01696396, used the name AMG 181 in their titles. Both names refer to the same investigational compound being developed by Amgen.