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Also known as AVT05 (proposed biosimilar to golimumab)
AVT05 · 1 trial · 1 indication
Change from baseline in DAS28-CRP response criteria at week 16
| Arm | Type | Description |
|---|---|---|
| AVT05 | EXPERIMENTAL | AVT05 is the proposed biosimilar to Simponi. Subjects in this arm will receive AVT05 50mg s.c. every 4 weeks until week 48. Intervention: Biological: Golimumab |
| Simponi | ACTIVE_COMPARATOR | Subjects in this arm will receive EU Simponi 50mg s.c. every 4 weeks until week 12. At week 16 responders will be re-randomized in a 1:1 ratio to receive either: AVT05 50mg s.c. every 4 weeks until week 48 Simponi 50mg s.c. every 4 weeks until week 48 Intervention: Biological: Golimumab |
| Name | Type | Description |
|---|---|---|
| AVT05 (proposed biosimilar to golimumab) | BIOLOGICAL | AVT05 is a recombinant human IgG1қ mAb developed as a subcutaneous injection |
| Simponi (Golimumab) | BIOLOGICAL | Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection |
Inclusion Criteria: * Subjects diagnosed with active RA according to ACR/EULAR 2010 classification criteria * Subjects diagnosed with moderately to severe active RA as defined by ≥ 6 swollen (out of 66) and ≥6 tender (out of 68) joint counts, CRP \>1mg/l and with at least one of positive rheumatoid...
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AVT05 is an investigational monoclonal antibody developed by Alvotech as a proposed biosimilar to golimumab. It is being studied for rheumatoid arthritis and targets TNF alpha. Alvotech is conducting clinical development under the ticker ALVO.
AVT05 is being developed for the treatment of rheumatoid arthritis. It is a proposed biosimilar to golimumab, a TNF alpha inhibitor. The clinical program includes a Phase 3 study in adults with rheumatoid arthritis.
AVT05 targets TNF alpha, a protein involved in inflammation. By binding TNF alpha, it is designed to reduce inflammatory signaling. This mechanism is the same as that of golimumab, the reference product for which AVT05 is a proposed biosimilar.
AVT05 is being developed by Alvotech, a biopharmaceutical company. Alvotech trades under the ticker ALVO. The company is advancing AVT05 as a proposed biosimilar to golimumab.
AVT05 is in Phase 3 clinical development. The Phase 3 study has been completed. AVT05 is investigational and has not been approved by the FDA.
AVT05 has been evaluated in a Phase 3 trial, NCT05842213, titled ALVOFLEX. This completed study enrolled 502 participants with rheumatoid arthritis in Bulgaria. It was a randomized, double-blind, active-controlled trial.
AVT05 is a proposed biosimilar to golimumab, not the same as the reference product. A biosimilar is designed to be highly similar to an approved biologic. AVT05 is being developed by Alvotech as a proposed biosimilar to golimumab.