Evaluating SR1375 for treating community-acquired pneumonia in adults

A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SR1375 in Hospitalized Adult Patients With Community-acquired Pneumonia

This study is testing a new medication called SR1375 to see if it helps adults in the hospital with community-acquired pneumonia feel better and recover safely.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. (industry)
• Drugs / interventions: Tocilizumab, Baricitinib, chemotherapy, immunotherapy
• Locations: 29 sites (Fuyang, Anhui and 28 other locations)
• Trial ID: NCT06577558 on ClinicalTrials.gov

What this trial studies

This phase 2 study aims to assess the efficacy and safety of SR1375 in hospitalized adult patients diagnosed with community-acquired pneumonia (CAP). Participants will be randomly assigned to receive either SR1375 at varying doses or a placebo for a duration of 8 weeks, followed by a 14-day safety follow-up. The study will involve around 240 subjects, with treatment assignments kept blinded to ensure unbiased results. Eligibility is determined based on specific clinical criteria, including the severity of pneumonia and the presence of high-risk factors.

Who should consider this trial

Good fit: Ideal candidates include hospitalized adults aged 18 and older with a diagnosis of community-acquired pneumonia and specific clinical severity criteria.

Not a fit: Patients requiring invasive mechanical ventilation or ECMO within 24 hours will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from community-acquired pneumonia.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for pneumonia.

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.

Where this trial is running

Fuyang, Anhui and 28 other locations

• Fuyang People's Hospital — Fuyang, Anhui, China (RECRUITING)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Zhangzhou Hospital — Zhangzhou, Fujian, China (RECRUITING)
• Gaozhou People's Hospital — Gaozhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• The Third Affiliated Hospital of Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
• Nanfang Hospital — Guangzhou, Guangdong, China (RECRUITING)
• The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China (RECRUITING)
• Yulin First People's Hospital — Yulin, Guangxi, China (RECRUITING)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)
• Daqing Longnan Hospital — Daqing, Heilongjiang, China (RECRUITING)
• Daqing People's Hospital — Daqing, Heilongjiang, China (RECRUITING)
• Shangqiu People's Hospital — Shangqiu, Henan, China (RECRUITING)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (RECRUITING)
• Yueyang Central Hospital — Yueyang, Hunan, China (RECRUITING)
• Nanjing First Hospital — Nanjing, Jiangsu, China (WITHDRAWN)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)
• Yanbian University Affiliated Hospital — Yanbian, Jilin, China (WITHDRAWN)
• Dalian Central Hospital — Dalian, Liaoning, China (RECRUITING)
• The Second Hospital of Dalian Medical University — Dalian, Liaoning, China (RECRUITING)
• Weifang Second People's Hospital — Weifang, Shandong, China (RECRUITING)
• Zibo Municipal Hospital — Zibo, Shandong, China (RECRUITING)
• Zhongshan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• Shanghai Tongren Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• The First Affiliated Hospital of Chengdu Medical College — Chengdu, Sichuan, China (RECRUITING)
• Lishui Central Hospital — Lishui, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Weimin Li, MD — West China Hospital
• Study coordinator: Wang, PhD

Conditions: Community-acquired Pneumonia, Community acquired Pneumonia, SR1375