Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial
Abstract Background CT‐P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT‐P39 to European Union‐approved and United States‐licensed reference omalizumab (EU‐ and US‐omalizumab, respectively). Methods This two‐part, randomi...
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| Format: | Article |
| Language: | English |
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Wiley
2022-11-01
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| Series: | Clinical and Translational Allergy |
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| Online Access: | https://doi.org/10.1002/clt2.12204 |
| _version_ | 1811185069148078080 |
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| author | Marcus Maurer Sarbjit S. Saini Kristi McLendon Paul Wabnitz Sunghyun Kim Keumyoung Ahn Suyoung Kim Sewon Lee Clive Grattan |
| author_facet | Marcus Maurer Sarbjit S. Saini Kristi McLendon Paul Wabnitz Sunghyun Kim Keumyoung Ahn Suyoung Kim Sewon Lee Clive Grattan |
| author_sort | Marcus Maurer |
| collection | DOAJ |
| description | Abstract Background CT‐P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT‐P39 to European Union‐approved and United States‐licensed reference omalizumab (EU‐ and US‐omalizumab, respectively). Methods This two‐part, randomised, parallel‐group, double‐blind Phase 1 trial (NCT04018313) was conducted in healthy individuals with a total immunoglobulin E (IgE) level ≤100 international units (IU)/ml at screening. In part 2, described herein, participants were randomised (1:1:1) to receive a single 150 mg subcutaneous dose of CT‐P39, EU‐omalizumab, or US‐omalizumab. The primary endpoint was pharmacokinetic equivalence in terms of area under the concentration–time curve (AUC) from time zero to the last quantifiable concentration (AUC0–last), AUC from time zero to infinity (AUC0‐inf), and maximum serum concentration (Cmax). Equivalence was concluded if 90% confidence intervals (CIs) of the geometric least‐squares means ratios were contained within the predefined 80%–125% equivalence margin. Additional pharmacokinetic parameters, pharmacodynamics, safety, and immunogenicity were also evaluated. Results Overall, 146 participants were randomised (CT‐P39, N = 47; EU‐omalizumab, N = 49; US‐omalizumab, N = 50). For all primary pharmacokinetic parameters, 90% CIs for pairwise treatment comparisons were within the 80%–125% equivalence margin, demonstrating pharmacokinetic equivalence. Decreases in free IgE and increases in total IgE serum concentrations were comparable across groups. CT‐P39 was well tolerated. Safety endpoints were comparable across groups: there were no treatment‐related serious adverse events, deaths, or discontinuations due to treatment‐emergent adverse events. Conclusions CT‐P39 was well tolerated and demonstrated pharmacokinetic equivalence with EU‐omalizumab and US‐omalizumab following administration of a single dose in healthy individuals. |
| first_indexed | 2024-04-11T13:23:14Z |
| format | Article |
| id | doaj.art-2ba1233eff264591b914b95213dfe671 |
| institution | Directory Open Access Journal |
| issn | 2045-7022 |
| language | English |
| last_indexed | 2024-04-11T13:23:14Z |
| publishDate | 2022-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Allergy |
| spelling | doaj.art-2ba1233eff264591b914b95213dfe6712022-12-22T04:22:08ZengWileyClinical and Translational Allergy2045-70222022-11-011211n/an/a10.1002/clt2.12204Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trialMarcus Maurer0Sarbjit S. Saini1Kristi McLendon2Paul Wabnitz3Sunghyun Kim4Keumyoung Ahn5Suyoung Kim6Sewon Lee7Clive Grattan8Institute of Allergology Charité – Universitätsmedizin Berlin Corporate Member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin GermanyJohns Hopkins University School of Medicine Johns Hopkins University Baltimore Maryland USANucleus Network Pty Ltd Herston Queensland AustraliacPHARMA Pty Ltd Adelaide South Australia AustraliaCelltrion, Inc. Incheon Republic of KoreaCelltrion, Inc. Incheon Republic of KoreaCelltrion, Inc. Incheon Republic of KoreaCelltrion, Inc. Incheon Republic of KoreaSt John's Institute of Dermatology Guy's Hospital London UKAbstract Background CT‐P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT‐P39 to European Union‐approved and United States‐licensed reference omalizumab (EU‐ and US‐omalizumab, respectively). Methods This two‐part, randomised, parallel‐group, double‐blind Phase 1 trial (NCT04018313) was conducted in healthy individuals with a total immunoglobulin E (IgE) level ≤100 international units (IU)/ml at screening. In part 2, described herein, participants were randomised (1:1:1) to receive a single 150 mg subcutaneous dose of CT‐P39, EU‐omalizumab, or US‐omalizumab. The primary endpoint was pharmacokinetic equivalence in terms of area under the concentration–time curve (AUC) from time zero to the last quantifiable concentration (AUC0–last), AUC from time zero to infinity (AUC0‐inf), and maximum serum concentration (Cmax). Equivalence was concluded if 90% confidence intervals (CIs) of the geometric least‐squares means ratios were contained within the predefined 80%–125% equivalence margin. Additional pharmacokinetic parameters, pharmacodynamics, safety, and immunogenicity were also evaluated. Results Overall, 146 participants were randomised (CT‐P39, N = 47; EU‐omalizumab, N = 49; US‐omalizumab, N = 50). For all primary pharmacokinetic parameters, 90% CIs for pairwise treatment comparisons were within the 80%–125% equivalence margin, demonstrating pharmacokinetic equivalence. Decreases in free IgE and increases in total IgE serum concentrations were comparable across groups. CT‐P39 was well tolerated. Safety endpoints were comparable across groups: there were no treatment‐related serious adverse events, deaths, or discontinuations due to treatment‐emergent adverse events. Conclusions CT‐P39 was well tolerated and demonstrated pharmacokinetic equivalence with EU‐omalizumab and US‐omalizumab following administration of a single dose in healthy individuals.https://doi.org/10.1002/clt2.12204biosimilarCT‐P39immunoglobulin Eomalizumabpharmacokinetics |
| spellingShingle | Marcus Maurer Sarbjit S. Saini Kristi McLendon Paul Wabnitz Sunghyun Kim Keumyoung Ahn Suyoung Kim Sewon Lee Clive Grattan Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial Clinical and Translational Allergy biosimilar CT‐P39 immunoglobulin E omalizumab pharmacokinetics |
| title | Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial |
| title_full | Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial |
| title_fullStr | Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial |
| title_full_unstemmed | Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial |
| title_short | Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial |
| title_sort | pharmacokinetic equivalence of ct p39 and reference omalizumab in healthy individuals a randomised double blind parallel group phase 1 trial |
| topic | biosimilar CT‐P39 immunoglobulin E omalizumab pharmacokinetics |
| url | https://doi.org/10.1002/clt2.12204 |
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