Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.
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.
Checked against the public recordLast updated Mar 18, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Aptarion Biotech AG
- Interventions being studied
- Drug: AON-D21; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Community-acquired pneumonia, confirmed or suspected of bacterial or viral origin. * Admitted to an ICU (or similar unit). * Requiring respiratory support by HFO ≥ 30 L/min with FiO2 ≥ 30% or NIV or IMV or ECMO. * CRP ≥ 50 mg/L. * PaO2/FiO2 ratio ≤ 150 mmHg. * Treatment initiation no more than 48 h after initiation of respiratory support (HFO ≥ 30 L/min with FiO2 ≥ 30%, NIV, IMV or ECMO). * Written informed consent. * Age ≥ 18 years to ≤ 85 years. * Body mass index ≥ 17.5 kg/m² and ≤ 40 kg/m². * For female participants of childbearing potential, agreement to use dual methods of contraception until Day 60. * For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 60 and to refrain from donating sperm during the study and for 3 months after the last infusion. Exclusion Criteria: * Refractory septic shock. * Not expected to survive 72 hours. * Hospital-acquired or ventilator-associated pneumonia or known or suspected pneumonia due to aspiration or other physical injury or trauma or tuberculosis. * Known or suspected hypersensitivity to AON-D21 or any components of the formulation used (e.g., PEG, mannitol or EDTA) or a history of clinically relevant allergy requiring continuous treatment, or of anaphylaxis. * Known fibrotic lung disease, bronchiectasis or any other known severe chronic respiratory disease. * Active malignant disease. * Factors other than a pathogen suspected or confirmed to be causative for the respiratory insufficiency. * Hepatocellular injury defined by an ALT or AST value ≥ 3 times the ULN. Known acute or chronic liver disease with Child-Pugh C (See Appendix 13.6.2). * Any medical disease or condition that, in the opinion of the investigator(s), compromises the participant's safety or compromises the interpretation of the results. * Receiving chronic immunosuppressive therapy in relevant doses. * Known immunodeficiency disease/condition. * Nursing and pregnant women (defined as the state after conception until the termination of gestation, screened in all women of child-bearing potential with a chorionic gonadotrophin (hCG) blood test (local laboratory). * Current or recent participation in an investigational trial. * Systemic treatment with any complement inhibitor. * Known complement deficiency. * Unlikely to remain at the investigational site beyond 96 h.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Alabama at Birmingham Heersink School of MedicineBirmingham, Alabama
- Cliniques Universitaires Saint-LucBrussels
- Clinique Saint PierreOttignies
- Centre Hospitalier ArgenteuilArgenteuil
- Centre Hospitalier Départemental VendéeLa Roche-sur-Yon
- CHU DupuytrenLimoges
- Centre Hospitalier de MelunMelun
- Hotel Dieu - CHU NantesNantes
- Assistance Publique-Hopitaux de Paris (AP-HP)Paris
- Nouvel Hôpital CivilStrasbourg
- CHRU de Tours Hôpital BretonneauTours
- Hôpital Nord Franche ComtéTrévenans
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 18, 2026. Always confirm current availability with the study team.