A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

Phase 2 Completed 168 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

Timeline

Start: 2015-01-14
Primary completion: 2017-05-23
Completion: 2017-05-23

Outcome

Missed primary endpoint

paper Compared to placebo+OTV, MHAA4549A+OTV did not significantly reduce the time to normalization of respiratory function PMID 32393496 ↗

registry analysis (other test); Placebo + Oseltamivir vs MHAA4549A 3600 mg + Oseltamivir; p = 0.6050; Hazard Ratio (HR) 1.08 (80% CI 0.83 to 1.40); Wilcoxon (Mann-Whitney) NCT02293863 ↗

registry analysis (other test); Placebo + Oseltamivir vs MHAA4549A 8400 mg + Oseltamivir; p = 0.2028; Hazard Ratio (HR) 1.13 (80% CI 0.85 to 1.51); Wilcoxon (Mann-Whitney) NCT02293863 ↗

Publications

Lim JJ, Nilsson AC, Silverman M, Assy N, Kulkarni P, McBride JM, Deng R, Li C, Yang X, Nguyen A, Horn P, Maia M, Castro A, Peck MC, Galanter J, Chu T, Newton EM, Tavel JA. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of MHAA4549A, a Monoclonal Antibody, plus Oseltamivir in Patients Hospitalized with Severe Influenza A Virus Infection. Antimicrob Agents Chemother. 2020 Jun 23;64(7):e00352-20. doi: 10.1128/AAC.00352-20. Print 2020 Jun 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GEDIVUMAB	Monoclonal antibody	3600 mg	Intravenous
Subject	GEDIVUMAB	Monoclonal antibody	8400 mg	Intravenous
Background	Oseltamivir	Small molecule	75 mg	Oral
Background	Oseltamivir	Small molecule	150 mg	Oral