NCT05962606

Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.

An Exploratory, Multi-Centre, Interventional, Prospective, Randomised, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of AON-D21 in Patients With Severe Community-Acquired Pneumonia.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Aptarion Biotech AG · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the safety and efficacy of AON-D21 versus placebo, both on top of standard of care, in patients with severe community acquired pneumonia admitted to ICU (or similar unit). The main questions to answer are: * The safety and tolerability of AON-D21 vs placebo. * The efficacy of AON-D21vs placebo. * The pharmacokinetics of AON-D21. * The pharmacodynamics of AON D21. * To identify biomarkers for patient stratification and analyses in future trials.

Detailed description

This clinical trial will enroll 100 participants, randomized 2:1 (AON-D21:placebo). Participants diagnosed with severe community-acquired pneumonia of bacterial or viral origin requiring admission to an intensive care unit or similar setting, will receive either AON-D21 or placebo intravenous infusions for up to 10 days. In addition, participants will receive standard of care as per local guidelines.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	AON-D21	AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.
DRUG	Placebo	Sterile liquid formulation of 5% glucose solution in matched glass vials with a 1.5 mL fill volume.

Timeline

• Start date: 2024-02-02
• Primary completion: 2026-03-16
• Completion: 2026-03-16
• First posted: 2023-07-27
• Last updated: 2026-03-18

Locations

27 sites across 6 countries: United States, Belgium, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study