NCT05722938

Efficacy and Safety of Trimodulin (BT588) in Subjects With Severe Community-acquired Pneumonia (sCAP)

A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With Severe Community-acquired Pneumonia (sCAP)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 590 (estimated)
• Sponsor: Biotest · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV). Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

Detailed description

This is a randomized, placebo-controlled, double-blind, multi-center, multi-national, phase III trial, to assess the efficacy and safety of trimodulin compared to placebo treatment, as adjunctive treatment to SoC in adult hospitalized subjects with sCAP receiving IMV. Subjects will be randomized on a 1:1 basis to receive trimodulin or placebo, stratified by center. Investigational medicinal product (IMP) treatments will be blinded. Subject will be administered IMP once daily on 5 consecutive days (day 1 through day 5) adjunctive to SoC. The subsequent follow-up phase comprises maximally 23 days (day 6 through day 28) followed by an end-of-follow-up visit/telephone call on day 29 \[+3\]. For subjects still in the hospital (trial site) after day 29, an extended follow-up is conducted until discharge or until day 90. For all subjects alive on day 29, a closing visit/telephone call on day 91 \[+10\] will be done.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Trimodulin	IMP will be administered via IV infusion on 5 consecutive days
DRUG	Placebo (human albumin 1%)	IMP will be administered via IV infusion on 5 consecutive days

Timeline

• Start date: 2023-09-09
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2023-02-10
• Last updated: 2026-04-03

Locations

147 sites across 18 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Czechia, France, Germany, Hungary, Ireland, Israel, New Zealand, Philippines, Romania, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study