A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions

Summary

The LTI-01-2001 study is a double-blind, placebo-controlled, Phase 2 study to evaluate LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions.

Timeline

Start

2020-09-26

Primary completion

2022-03-31

Completion

2022-07-28

Outcome

Missed primary endpoint

paper There was no significant difference in incidence of treatment failure between the LTI-01 and placebo groups (OR 1.04, 95% CI 0.24,4.44, P = 0.96) PMID 42310706 ↗

Publications

• Lamb CR, Akulian J, Musani A, Shojaee S, Chen A, Kurman J, Jani P, Senitko M, Ahmad D, Wahidi M, Ansari S, Abu-Hijleh M, Ma KC, Puchalski J, Yarmus L, Kheir F, Maldonado F, Cheng G, Alvarado C, Karan SP, Windsor B, Rahman NM, Shoemaker S, Idell S. The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions. Respir Res. 2026 Jun 17. doi: 10.1186/s12931-026-03782-4. Online ahead of print.

Drugs

Indications