Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia

Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia (NCT06624436) is a Phase 4 interventional studying Sepsis and Neuroinflammatory Response, sponsored by Radboud University Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are: * What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model? * What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model? Researchers will compare these drugs to a placebo (a look-alike substance that contains no drug). Participants will visit the Intensive Care research department on two or five occasions (screening included): * The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord. * The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group. During an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 52 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Sepsis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form (IC) prior to enrolment in the study. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

Dexamethasone

Dexamethasone 6mg in 10mL NaCl 0.9% i.v. bolus + 100mL NaCl 0.9% placebo infusion in 1 hour on the first LPS challenge.

DRUG

Tocilizumab

Tocilizumab 600mg in 100mL NaCl 0.9% i.v. in 1 hour + a bolus of 10mL NaCl 0.9% placebo infusion on the first LPS challenge.

DRUG

Anakinra

Anakinra 200mg in 100mL NaCl 0.9% i.v. in 1 hour + a bolus of 10mL NaCl 0.9% placebo infusion on the first LPS challenge.

DRUG

Placebo

Bolus of 10mL NaCl 0.9% placebo + 100mL NaCl 0.9% placebo infusion in 1 hour on the first LPS challenge.

BIOLOGICAL

LPS

This is a non-investigational product. It is used as challenge agent to achieve a controlled inflammatory state.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Intensive Care Medicine, Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06624436), the sponsor (Radboud University Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06624436 clinical trial studying?

Who can participate in NCT06624436?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06624436?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06624436. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06624436. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.