Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

Phase 2/3 Completed 149 enrolled I-Mab Biopharma US Limited

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, multi-center trial to evaluate the safety and efficacy of TJ003234 administered as an intravenous (IV) infusion in subjects with severe COVID-19 under supportive care, and to assess the effect of TJ003234 on the levels of cytokines.

Timeline

Start: 2020-04-11
Primary completion: 2022-02-07
Completion: 2022-02-07

Outcome

Missed primary endpoint

registry analysis (superiority test); TJ003234 6mg/kg (Part 2) vs TJ0032034 10mg/kg (Part 2); p = .28; Median Difference (Final Values) 9 (95% CI -6.5 to 27); Fisher Exact NCT04341116 ↗

Publications

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plonmarlimab	Monoclonal antibody	—	Intravenous