Drugs / AVT04
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04744363 | May 2021 → Mar 2022 | psoriasis | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04930042 | Jun → Dec 2021 | psoriasis | Alvotech Swiss AG | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-06-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Secure U.S. License Date for AVT04, a Proposed Biosimilar to Stelara® tevapharm.com ↗ |
| 2023-01-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab) tevapharm.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVT04 | “A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in...” PMID 37212315 ↗ May 2023 |
| Modality | Monoclonal antibody | “AVT04 is a fully human immunoglobulin class G1κ monoclonal antibody” NCT04930042 ↗ |
| Route | Subcutaneous | “when administered as a single 45 mg/0.5 mL SC injection” NCT04744363 ↗ |