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ML Risk
AIN457A · 2 trials · 2 indications
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen.
| Arm | Type | Description |
|---|---|---|
| AIN457/AIN457 3 mg/kg. | EXPERIMENTAL | Participants who were treated with secukinumab 2x10 mg/kg during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| Placebo/AIN457 3 mg/kg. | PLACEBO_COMPARATOR | Participants who were treated with placebo during the core study were treated with secukinumab at 3mg/kg infused intravenously every 4 weeks during the extension study, over a total period of 52 weeks. |
| AIN457 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AIN457A | BIOLOGICAL | - |
| Other | OTHER | - |
Inclusion Criteria: * Patients who participated and completed the core CAIN457A2206 study up to and including the end of the study (EoS) Visit, i.e. Visit 16 (Week 24), were allowed to enter the extension study upon signing informed consent. * Patients who discontinued the core study due to unsatis...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Novartis AG Sponsored ADR | NVS | 1 | - | Secukinumab |
| Pfizer Inc. | PFE | 1 | - | Tofacitinib |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
AIN457A is an investigational monoclonal antibody being studied for the treatment of psoriatic arthritis and ankylosing spondylitis. It is in Phase 2 clinical development for these conditions.
AIN457A is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS.
AIN457A is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA.
AIN457A has been studied in two completed Phase 2 trials. One trial, NCT01109940, enrolled 39 adults with moderate to severe ankylosing spondylitis. Another trial, NCT01169844, enrolled 28 adults with psoriatic arthritis.
AIN457A is an alternative name for secukinumab, a monoclonal antibody developed by Novartis. It is being investigated for use in psoriatic arthritis and ankylosing spondylitis.