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Label indication HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid a rthritis . FDA label
Also known as Humira
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...
Adalimumab originator is a monoclonal antibody developed by Alvotech (ticker ALVO) as a biosimilar candidate referencing the TNF inhibitor adalimumab. It is being studied in plaque psoriasis and is currently in Phase 3 clinical development. Alvotech is developing it as an alternative to the reference adalimumab product.
Adalimumab originator is being evaluated for the treatment of moderate to severe chronic plaque psoriasis in adults. The Phase 3 trial enrolled 567 participants aged 18 years and older with this condition. It is an investigational biosimilar and is not yet approved for this indication.
Adalimumab originator targets tumor necrosis factor, or TNF, acting as a TNF inhibitor. By binding TNF, it is designed to reduce the inflammatory signaling that drives plaque psoriasis. This mechanism is the same class as the reference adalimumab product it is intended to match.
Adalimumab originator is being developed by Alvotech, which trades under the ticker ALVO. Alvotech is advancing this monoclonal antibody as a biosimilar candidate in plaque psoriasis. The company is the sponsor of the clinical program.
Adalimumab originator is in Phase 3 clinical development. Its single Phase 3 trial has been completed, and no active trials are currently listed. It remains an investigational product and has not been approved by the FDA for any indication.
Adalimumab originator was studied in the Phase 3 trial NCT04453137, titled Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis. The trial enrolled 567 participants across Georgia, Iceland, Poland, Russia, and Ukraine, was randomized, double-blind, and active-controlled, and is now completed.