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A randomized, double-blind, 3-arm, parallel study assessing the pharmacokinetics, safety, tolerability and immunogenicity of AVT04, an ustekinumab candidate biosimilar, in healthy adults.
Wynne C, Hamilton P, McLendon K, Stroissnig H, Smith M, Duijzings P, Ruffieux R, Otto H, Sattar A, Haliduola HN, Leutz S, Berti F. Wynne C, et al. Among authors: sattar a. Expert Opin Investig Drugs. 2023 May;32(5):417-427. doi: 10.1080/13543784.2023.2215426. Epub 2023 May 23. Expert Opin Investig Drugs. 2023. PMID: 37212315 Free article. Clinical Trial.
A randomized, adaptive design, double-blind, 3-arm, parallel study assessing the pharmacokinetics and safety of AVT02, a high-concentration (100 mg/mL) Adalimumab biosimilar, in healthy adult subjects (ALVOPAD FIRST).
Wynne C, Schwabe C, Lemech C, Stroissnig H, Dias R, Sobierska J, Guenzi E, Otto H, Sattar A, Kay R, Haliduola HN, Berti F. Wynne C, et al. Among authors: sattar a. Expert Opin Investig Drugs. 2022 Sep;31(9):965-976. doi: 10.1080/13543784.2022.2035359. Epub 2022 Feb 10. Expert Opin Investig Drugs. 2022. PMID: 35107050 Free article. Clinical Trial.
A multicenter, randomized, open-label, 2-arm parallel study to compare the pharmacokinetics, safety and tolerability of AVT02 administered subcutaneously via prefilled syringe or autoinjector in healthy adults.
Wynne C, Schwabe C, Stroissnig H, Dias R, Sobierska J, Guenzi E, Otto H, Sattar A, Haliduola HN, Edwald E, Berti F. Wynne C, et al. Among authors: sattar a. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):773-780. doi: 10.1080/14712598.2022.2131391. Epub 2022 Oct 5. Expert Opin Biol Ther. 2023. PMID: 36197309 Free article.
Assessing the Interchangeability of AVT02 and Humira® in Participants with Moderate‑to‑Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study.
Feldman SR, Kay R, Reznichenko N, Sobierska J, Dias R, Otto H, Haliduola HN, Sattar A, Ruffieux R, Stroissnig H, Berti F. Feldman SR, et al. Among authors: sattar a. BioDrugs. 2023 Jul;37(4):551-567. doi: 10.1007/s40259-023-00600-x. Epub 2023 May 19. BioDrugs. 2023. PMID: 37204631 Free PMC article. Clinical Trial.
Assessment of real-life patient handling experience of AVT02 administered subcutaneously via autoinjector in patients with moderate to severe active rheumatoid arthritis: an open-label, single-arm clinical trial, then an extension phase of AVT02 administered with a prefilled syringe.
Damjanov N, Kirvalidze N, Kurashvili N, Berti F, Steiger M, Sobierska J, Guenzi E, Otto H, Sattar A, Haliduola HN, Edwald E, Stroissnig H. Damjanov N, et al. Among authors: sattar a. Expert Opin Biol Ther. 2023 Jul-Dec;23(8):781-789. doi: 10.1080/14712598.2022.2131392. Epub 2022 Oct 26. Expert Opin Biol Ther. 2023. PMID: 36205514 Free article.
577 results