YD0743 for sepsis-associated ARDS in adults

A Multicenter, Parallel, Randomized, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of YD0743 Injection in the Treatment of Sepsis-Associated Acute Respiratory Distress Syndrome

This trial will test whether YD0743 can shorten the number of days adults in the ICU with sepsis-associated ARDS need a ventilator and whether the drug is safe to use.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 309 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Huilun Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07413094 on ClinicalTrials.gov

What this trial studies

Adults (18–75) with sepsis-associated ARDS admitted to the ICU within 48 hours of ARDS diagnosis will receive either YD0743 injections or a matching placebo for at least seven days. Outcomes include ventilator-using days and monitoring of adverse events, with an in-person follow-up visit on Day 28. Participants (or their legally authorized representatives) must provide informed consent before enrollment. The comparison against placebo is intended to determine both efficacy and safety signals in this phase 2 setting.

Who should consider this trial

Good fit: Adults aged 18 to 75 with sepsis suspected or confirmed to have caused ARDS, who can be enrolled within 48 hours of ARDS diagnosis and provide informed consent (or have a representative do so), are the intended participants.

Not a fit: Patients with expected survival under 48 hours, sepsis primarily from extensive burns, active metastatic cancer or severe uncontrolled organ dysfunction, or known hypersensitivity to the drug are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If effective, YD0743 could reduce the time patients need mechanical ventilation and lower complications related to prolonged ventilator use.

How similar studies have performed: Previous trials of experimental anti-inflammatory or biologic agents in sepsis-related ARDS have produced mixed results, so this specific agent and approach are not yet proven.

Eligibility criteria

Inclusion Criteria:

* Male or female, aged between 18 and 75 years (inclusive).
* Diagnosis of sepsis.
* Diagnosis of Acute Respiratory Distress Syndrome (ARDS) suspected or confirmed to be caused by sepsis.
* Time from ARDS diagnosis to signing the informed consent form (ICF) does not exceed 48 hours.
* The subject (or their legally authorized representative) has fully understood the study's purpose, nature, procedures, and potential adverse events, voluntarily agrees to participate, and provides written informed consent.

Exclusion Criteria:

* Known allergy or hypersensitivity to the active ingredient or any excipients of the investigational product; or a history of allergic disorders.
* Expected survival time is less than 48 hours at the time of screening.
* Sepsis with extensive burns as the primary cause.
* Currently diagnosed with active malignancy; or malignancy with distant metastasis; or cancer patients with cachexia; or patients with severe organ dysfunction or visceral hemorrhage due to tumor obstruction, space-occupying effect, or compression, for whom surgical intervention is difficult or has not yet been performed.
* Currently receiving or requiring Extracorporeal Membrane Oxygenation (ECMO) therapy.
* Presence of chronic severe organ failure or immunodeficiency/immunosuppression.
* Thrombocytopenia at screening, active/uncontrolled bleeding, or patients whom the investigator considers to have a current or prior high risk of bleeding.
* Diagnosis of neutropenia.
* Positive for Hepatitis B surface antigen (HBsAg) with HBV-DNA \> 1000 copies/mL or 200 IU/mL; positive for Hepatitis C virus antibody (HCV-Ab); positive for Human Immunodeficiency Virus antibody (HIV-Ab); or positive for Treponema pallidum antibody.
* Participation in other drug or medical device clinical trials within 3 months prior to this study, or current participation in another clinical trial.
* Pregnant or breastfeeding women, or women planning to become pregnant within the next 6 months.
* Patients whose underlying primary disease cannot be effectively treated.
* Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this study.

Where this trial is running

Beijing

• Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Bin Du, Dr. — Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
• Study coordinator: WenJing Zhang

Conditions Sepsis; Acute respiratory distress syndrome