Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AT-1501
Tegoprubart · 4 trials · 3 indications
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
Incidence of adverse events (AEs) reported as number of participants with at least one TEAE (Treatment Emergent Adverse Event) and at least one SAE (Serious Adverse Event).
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Maximum observed plasma concentration (Cmax)
Time to reach maximum observed plasma concentration (Tmax)
Terminal elimination rate constant (Ke)
Terminal phase half-life (t1/2)
Clearance (CL)
Volume of distribution at steady state (Vdss)
| Arm | Type | Description |
|---|---|---|
| AT-1501 | EXPERIMENTAL | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Tacrolimus | ACTIVE_COMPARATOR | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
| Investigative | EXPERIMENTAL | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Comparator | ACTIVE_COMPARATOR | Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
| AT-1501 Single Arm | EXPERIMENTAL | AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
| Name | Type | Description |
|---|---|---|
| AT-1501 | DRUG | AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent |
| Tacrolimus | DRUG | Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent |
Inclusion Criteria: * Successfully completed qualifying Parent study, where entry into the OLE was offered; * Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent; * Agree not to participate in...