Effects of Dexamethasone, Tocilizumab, and Anakinra on Immune Response in Healthy Volunteers
Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia
This study is testing how three different medications can affect the immune response in healthy young men when they are exposed to a substance that mimics a severe infection.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Male |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | tocilizumab |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06624436 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the immunomodulatory effects of dexamethasone, tocilizumab, and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. Participants will receive an LPS challenge to induce a sepsis-like inflammatory response, with one of the drugs administered prior to the first challenge. The study aims to assess how these drugs influence the development of immunoparalysis and neuroinflammation by measuring cytokine levels in blood, saliva, tear fluid, and cerebrospinal fluid. The findings could provide insights into managing sepsis-induced immune suppression.
Who should consider this trial
Good fit: Ideal candidates are healthy male volunteers aged 18 to 35 with a BMI between 18 and 30.
Not a fit: Patients with a history of immune deficiency, severe atopic syndrome, or recent cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for sepsis and related conditions by enhancing immune responses.
How similar studies have performed: Other studies have shown promise in using immunomodulatory drugs for sepsis, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male subjects aged ≥18 and ≤35 years * Body mass index (BMI) ≥18 and ≤30 kg/m2 * Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters) * Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study. Exclusion Criteria: * Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs * Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients * History of chronic headache or previous post-dural puncture headache (PDPH) * History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema) * History of any disease associated with immune deficiency * History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ) * History or signs of haematological disease * History or signs of thromboembolic disorders * History of peptic / gastric ulcer disease * History of psychiatric disorders * Thrombocytopenia (\<150\*109/mL) or anaemia (\<8.0 mmol/L) * History, signs or symptoms of cardiovascular disease, in particular: * Prone to vagal collapse * History of atrial or ventricular arrhythmia * Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block * Hypertension (defined as RR systolic \> 160 or RR diastolic \> 90 mmHg) * Hypotension (defined as RR systolic \< 100 or RR diastolic \< 50 mmHg) * Renal impairment (defined as plasma creatinine \>120 μmol/L) * Liver enzyme abnormalities (above 2x the upper limit of normal) * Signs of infection (CRP \> 20 mg/L, white blood cells \> 12x109/L or * lt; 4x109/L) * Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge * Previous (participation in a study with) endotoxin (LPS) administration * Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge * Any vaccination or blood donation within 1 month prior to the first LPS challenge * Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge * Use of recreational drugs within 2 weeks prior to the first LPS challenge * Suspected of not being able to comply with the trial protocol * Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study
Where this trial is running
Nijmegen, Gelderland
- Intensive Care Medicine, Radboud University Nijmegen Medical Centre — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nicole Waalders, MD
- Email: nicole.waalders@radboudumc.nl
- Phone: +31243668420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.