Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVT05 · 2 trials · 2 indications
Change from baseline in DAS28-CRP response criteria at week 16
The primary PK parameters to be compared is Cmax and AUC0-inf.
| 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 |
| AVT05 50mg s.c. | EXPERIMENTAL | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| EU Simponi 50mg s.c. | ACTIVE_COMPARATOR | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| US Simponi 50mg s.c. | ACTIVE_COMPARATOR | Single dose Pre-filled syringe to be injected subcutaneously into thigh or abdomen |
| 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 |
| AVT05 | BIOLOGICAL | Pre filled syringes filled with AVT05 |
| Simponi | BIOLOGICAL | Pre filled syringes filled with Simponi |
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 being studied for use in healthy adult subjects and in patients with rheumatoid arthritis. It is being developed as a potential biosimilar to Simponi, and clinical studies have evaluated its pharmacokinetics, safety, and tolerability compared with US and EU versions of Simponi.
AVT05 is a monoclonal antibody that targets tumor necrosis factor alpha, a key inflammatory cytokine involved in autoimmune conditions like rheumatoid arthritis. By binding to this target, it is designed to modulate the inflammatory response, though it remains investigational and has not been approved by regulatory authorities.
AVT05 is being developed by Alvotech, a biopharmaceutical company focused on biosimilars. Alvotech is publicly traded under the ticker ALVO. The company has conducted clinical trials for AVT05 in healthy volunteers and in patients with rheumatoid arthritis.
AVT05 has completed a Phase 1 clinical trial and a Phase 3 clinical trial. The Phase 1 study investigated its pharmacokinetics, safety, and tolerability in healthy adults, while the Phase 3 study, called ALVOFLEX, compared it in patients with rheumatoid arthritis. AVT05 is still investigational and not yet approved.
AVT05 has been studied in two completed clinical trials. NCT05632211 was a Phase 1 study in healthy adult participants in New Zealand and the United Kingdom, with 336 enrolled. NCT05842213 was a Phase 3 study in patients with rheumatoid arthritis in Bulgaria, with 502 enrolled. Both trials were randomized and double-blind.
AVT05 is being developed as a potential biosimilar to Simponi, which is a brand-name biologic. Clinical trials have directly compared AVT05 with US and EU versions of Simponi to evaluate pharmacokinetic similarity, safety, and tolerability. However, AVT05 is a distinct investigational product and is not yet approved.