NCT06513949 is a Phase 2 clinical trial of Atibuclimab in Acute Respiratory Distress Syndrome, sponsored by Implicit Bioscience.

Who is sponsoring NCT06513949?

NCT06513949 is sponsored by Implicit Bioscience.

What drugs are being tested in NCT06513949?

Interventions in NCT06513949: Atibuclimab, Placebo.

What condition does NCT06513949 study?

NCT06513949 studies Acute Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Acute Lung Injury, Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS).

Is NCT06513949 still recruiting?

NCT06513949 is currently recruiting now. Last updated 15 August 2025.

Last reviewed 2025-08-15 · How we verify

NCT06513949

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody (IC14) in Hospitalized Patients With Acute Respiratory Distress Syndrome

Recruiting now Phase 2 Last updated 15 August 2025

What this trial tests

Phase 2 trial testing Atibuclimab in Acute Respiratory Distress Syndrome in 56 participants. Currently enrolling.

Timeline

15 August 2025

Primary endpoint
1 September 2027

1 December 2027

Quick facts

Lead sponsor	Implicit Bioscience
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	56
Start date	15 August 2025
Primary completion	1 September 2027
Estimated completion	1 December 2027
Sites	2 locations across United States

Drugs / interventions tested

Atibuclimab — full drug profile →
Placebo

Conditions studied

Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
Adult Respiratory Distress Syndrome — all drugs for Adult Respiratory Distress Syndrome →
Acute Lung Injury — all drugs for Acute Lung Injury →
Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) — all drugs for Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) →

Sponsor

Implicit Bioscience — full company profile →

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome or Adult Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Day 4 Oxygenation Index
Time frame: Day 1 through Day 4
(mean airway pressure x fraction of inspired oxygen \[FiO2\] x100)/ partial pressure of oxygen \[PaO2\]

Sponsor's own description

Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days. The primary outcome is the day 4 oxygenation index assessed as a continuous measure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Extracellular Vesicles as Drivers of Lung Endothelial Dysfunction in ARDS: Mechanisms and Therapeutic Opportunities.
Al Matni MY, Belvitch P, Dudek SM, Letsiou E. · · 2026 · PMID 42244045 · DOI 10.1002/cph4.70179

Verify or expand the search:

Other recruiting trials for Acute Respiratory Distress Syndrome

Currently open trials in the same condition.

NCT07284888 — Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry- · recruiting
NCT07289711 — Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter C · recruiting
NCT07326215 — A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ · NA · recruiting
NCT06919484 — The Physiological Effect of RCexp on Ventilation/Perfusion Distribution · recruiting
NCT07126964 — Extended Prone Positioning for Intubated ARDS · NA · recruiting

Other Implicit Bioscience trials

Trials by the same sponsor.

NCT06678074 — Pilot Study of IC14 (Atibuclimab), an Anti-CD14 Monoclonal Antibody, to Treat STEMI · Phase 1, PHASE2 · active not recruiting
NCT06556810 — IC14 for Treatment of Acute Decompensated Heart Failure · Phase 1, PHASE2 · active not recruiting
NCT06275893 — IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy · Phase 1, PHASE2 · suspended
NCT03508453 — IC14 for Treatment of Amyotrophic Lateral Sclerosis · Phase 2 · withdrawn
NCT03474263 — IC14 for Rapidly Progressive Amyotrophic Lateral Sclerosis (ALS) · Phase 2 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06513949 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Implicit Bioscience
Last refreshed: 15 August 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06513949.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing