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Parallel-Group Treatment, Double-Blind, 2-Arm to Investigate Comparative Efficacy Safety Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects 18 to 80 Years Inclusive, Moderate to Severe Ulcerative Colitis

The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis.

开始日期2024-09-30

申办/合作机构

Alvotech Swiss AG

CTIS2023-507705-34-00 / Recruiting

A Parallel-Group Treatment, Double-Blind, 2-Arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects Aged 18 to 80 Years Inclusive with Moderate to Severe Active Ulcerative Colitis - AVT16-GL-C01

开始日期2024-09-23

申办/合作机构

Alvotech Swiss AG

NCT06400719 / Active, not recruiting临床1期

An Open Label, Single Arm Pilot Study to Investigate the Safety and Tolerability of a Single 300mg Intravenous Dose of AVT16 in Healthy Adult Subjects Aged 18 to 55 Years Inclusive

This is a pilot study in healthy adult subjects to evaluate the safety and tolerability of AVT16 after administration of a single intravenous administration. Pharmacokinetics and immunogenicity of AVT16 will also be evaluated.

开始日期2024-05-29

申办/合作机构

Alvotech Swiss AG

100 项与 Alvotech Swiss AG 相关的临床结果

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0 项与 Alvotech Swiss AG 相关的专利（医药）

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项与 Alvotech Swiss AG 相关的文献（医药）

Joint analysis of PK and immunogenicity outcomes using factorization model − a powerful approach for PK similarity study

作者: Stroissnig, Heimo ; Otto, Hendrik ; Sattar, Abid ; Haliduola, Halimu N. ; Berti, Fausto ; Guenzi, Eric ; Mansmann, Ulrich

AbstractBiological products, whether they are innovator products or biosimilars, can incite an immunogenic response ensuing in the development of anti-drug antibodies (ADA). The presence of ADA’s often affects the drug clearance, resulting in an increase in the variability of pharmacokinetic (PK) analysis and challenges in the design and analysis of PK similarity studies. Immunogenic response is a complex process which may be manifested by product and non-product-related factors. Potential imbalances in non-product-related factors between treatment groups may lead to differences in antibodies formation and thus in PK outcome. The current standard statistical approaches dismiss any associations between immunogenicity and PK outcomes. However, we consider PK and immunogenicity as the two correlated outcomes of the study treatment. In this research, we propose a factorization model for the simultaneous analysis of PK parameters (normal variable after taking log-transformation) and immunogenic response subgroup (binary variable). The central principle of the factorization model is to describe the likelihood function as the product of the marginal distribution of one outcome and the conditional distribution of the second outcome given the previous one. Factorization model captures the additional information contained in the correlation between the outcomes, it is more efficient than models that ignore potential dependencies between the outcomes. In our context, factorization model accounts for variability in PK data by considering the influence of immunogenicity. Based on our simulation studies, the factorization model provides more accurate and efficient estimates of the treatment effect in the PK data by taking into account the impact of immunogenicity. These findings are supported by two PK similarity clinical studies with a highly immunogenic biologic.

100 项与 Alvotech Swiss AG 相关的药物交易

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100 项与 Alvotech Swiss AG 相关的转化医学

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