Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
Summary
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.
Timeline
- Start
- 2017-01-11
- Primary completion
- 2018-04-12
- Completion
- 2018-04-20
Outcome
Met primary endpoint
registry MEDIAN Baloxavir Marboxil: 73.2 (67.2 to 85.1) hours MEDIAN Placebo: 102.3 (92.7 to 113.1) hours NCT02949011 ↗
registry analysis (superiority test); Baloxavir Marboxil vs Placebo; p <0.0001; Median Difference -29.1 (95% CI -42.8 to -14.6) NCT02949011 ↗
release “CAPSTONE-2 showed that baloxavir marboxil significantly reduced time to improvement of influenza symptoms versus placebo” gene.com ↗
release “met the study’s primary objective” gene.com ↗
release “CAPSTONE-2 are as follows: ・ Xofluza® significantly reduced the time to improvement of influenza symptoms (TTIIS, the primary endpoint) versus placebo” shionogi.com ↗
release “median time to improvement in symptoms 73.2 hours for Xofluza, 102.3 hours for placebo, p<0.0001” shionogi.com ↗
Publications
- Retout S, De Buck S, Jolivet S, Duval V, Cosson V. A Pharmacokinetics-Time to Alleviation of Symptoms Model to Support Extrapolation of Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B. Clin Pharmacol Ther. 2022 Aug;112(2):372-381. doi: 10.1002/cpt.2648. Epub 2022 Jun 10.
- Ison MG, Portsmouth S, Yoshida Y, Shishido T, Mitchener M, Tsuchiya K, Uehara T, Hayden FG. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020 Oct;20(10):1204-1214. doi: 10.1016/S1473-3099(20)30004-9. Epub 2020 Jun 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baloxavir Marboxil | Unknown | 40 mg | Oral |
| Subject | Baloxavir Marboxil | Unknown | 80 mg | Oral |
| Comparator | Oseltamivir | Small molecule | 75 mg | Oral |