Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adalimumab originator · 1 trial · 1 indication
Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUCtau, 26-28) of AVT02 and Humira
Venous blood samples will be collected for measurement of serum concentration of AVT02 and Humira
| Arm | Type | Description |
|---|---|---|
| Humira 40 mg/mL (Adalimumab Originator) | ACTIVE_COMPARATOR | During the LeadIn Period, patients will receive Humira (initial dose of 80 mg \[2 × 40 mg\] administered subcutaneously \[SC\], followed by 40 mg SC given every other week starting 1 week after the initial dose). At Week 12, responsive patients (Psoriasis Area and Severity Index \[PASI\] ≥ 75 \[PASI75\]) will be randomly assigned in a 1:1 ratio to either of the following groups for participation in the Double-Blind Switching Module. |
| IC - Humira 40 mg/mL (Adalimumab Originator) | ACTIVE_COMPARATOR | patients continue to receive Humira 40 mg every other week from Week 12 until Week 26 (8 injections) |
| IC - Humira/AVT02 40 mg/mL (Adalimimab Biosimilar) | EXPERIMENTAL | patients undergo repeated switches (Sw) of AVT02 and Humira from Week 12 until Week 26: * Sw1-AVT02 (40 mg every other week) for 4 weeks (2 injections), * Sw2-Humira (40 mg every other week) for 4 weeks (2 injections), * Sw3-AVT02 (40 mg every other week) for 8 weeks (4 injections). |
| AVT02 40 mg/mL (Adalimimab Biosimilar) | EXPERIMENTAL | At Week 28, after the EoS IC visit, responsive patients (PASI ≥ 50 \[PASI50\]) will be offered to continue with the optional open-label Extension Phase (Weeks 28 to 52). AVT02 40 mg will be administered every other week starting from Week 28 (after completing EoS IC assessments), ending with the final study drug administration at Week 50. The EoS visit is planned for Week 52. |
| Name | Type | Description |
|---|---|---|
| Adalimumab originator | BIOLOGICAL | Subcutaneous injection every other week |
| Adalimumab biosimilar | BIOLOGICAL | Subcutaneous injection every other week |
Inclusion Criteria: 1. Patient has signed the informed consent form and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements. 2. Patient is male or female aged 18 to 75 years, inclusive, at the time of Screenin...