Efficacy and Safety of SR1375 in Adult Patients With CAP

Launched by SHANGHAI SIMR BIOTECHNOLOGY CO., LTD. · Aug 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SR1375 to see how well it works and how safe it is for adult patients who have community-acquired pneumonia (CAP). Community-acquired pneumonia is an infection in the lungs that people can get outside of a hospital setting. The trial will involve patients who are hospitalized and will last for up to 10 weeks, with participants receiving either SR1375 or a placebo (a treatment that looks the same but has no active medication) for 8 weeks.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with CAP. They should also have a specific level of oxygen saturation and at least one high-risk health condition such as chronic lung disease, diabetes, or being over 65 years old. During the trial, participants can expect regular check-ins to monitor their health and any side effects. It’s important to note that certain people, like those needing immediate invasive breathing support or those with specific severe health issues, will not be able to join the study. This trial is currently recruiting participants, and both men and women are welcome to apply.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • The subject or their legally acceptable representative (LAR) has voluntarily signed the informed consent form (ICF) prior to any study-related procedures, and the subject is willing and able to comply with all study requirements, restrictions, and procedures. If consent is provided by an LAR for a subject with limited or no capacity to consent, re-consenting may be performed if the subject regains capacity.
• • Aged 18 to 85 years.
• • Diagnosis of CAP
• • Prior to screening, the subject has been receiving standard-of-care treatment for pneumonia in a medical institution, including at least 3 days of intravenous (IV) anti-infective therapy, with no clinical improvement.
• • Chest CT showing multi-lobar infiltrates, and for subjects not receiving invasive mechanical ventilation, an oxygenation index (PaO2/FiO2 ratio) between 100 and 300 mmHg.
• • Expected to require continued hospitalization for at least 7 days from the time of signing the ICF.
• • Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygen saturation ≤ 93% without oxygen inhalation, 6 points or 7points. (5 points refer to hospitalization with oxygen therapy; 6 points refer to hospitalization with high flow oxygen therapy or non-invasive mechanical ventilation. 7 points refer to hospitalization with invasive mechanical ventilation).High oxygen flow refers to ≥ 4 L/min.)
• • With ≥ 1 high risk factors including chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, type 2 diabetes, chronic kidney disease, coronary heart disease, age ≥ 65 years, moderate obesity (body mass index\>32.5kg/m2), etc.
• • Participants of women of childbearing potential(WOCBP) and male participants with WOCBP partners must agree to use one or more effective contraceptive methods during the treatment period and until 90 days after the last administration.
• Key Exclusion Criteria:
• • Patients who are currently receiving or are expected to require ECMO treatment within 24 hours.
• • Presence of active tuberculosis (TB) or severe asthma.
• • History of unstable angina or acute myocardial infarction within 3 months prior to screening, or stroke within 4 weeks prior to screening.
• • Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeks prior to randomization, or are planned to receive such treatment during the study period; presence of a hematological malignancy not in complete remission; or a lung tumor with concurrent obstructive pneumonia.
• • Presence of any concomitant disease that is expected to result in death within 12 weeks after randomization.
• • Prior use of JAK inhibitors (e.g., Baricitinib), interleukin receptor inhibitors (e.g., Tocilizumab), or any investigational drug in another clinical trial, where the last dose was administered less than 5 half-lives before the first dose of the study drug in this trial.
• • ALT) or AST \> 3 times the upper limit of normal (ULN).
• • eGFR \< 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula); however, patients undergoing dialysis may be included upon the investigator's assessment of their suitability for the trial.
• • Presence of clinically significant abnormalities on ECG that may seriously affect subject safety, e.g., QTcF \> 480 ms.
• • Female subjects who are pregnant, lactating, or have a positive serum β-HCG pregnancy test.
• • Presence of any severe systemic disease or clinical condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.