Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on FX06 for Improving Acute Respiratory Distress Syndrome in Patients

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called FX06 on patients with Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition that affects the lungs, making it difficult for patients to breathe on their own. The treatment being tested, FX06, is a solution for injection that contains a substance known as glutenin. The study will compare the effects of FX06 with a placebo to see if it can help improve the severity of the disease.

The main goal of the study is to determine if FX06 can reduce the time it takes for patients to start breathing without assistance. Participants in the study will receive either FX06 or a placebo, and their progress will be monitored over a period of 28 days. The study will look at various factors, including how the disease progresses or improves, lung function, and overall survival. Other aspects such as inflammation levels, hospital stay duration, and safety will also be assessed.

Throughout the study, participants will undergo regular check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable insights into whether FX06 can be an effective treatment for ARDS, potentially leading to better outcomes for patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must have a confirmed diagnosis of mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin Definition.

    The patient must be at least 18 years old and provide written informed consent, either personally or through a legal representative.

    Randomization into the study occurs within 48 hours of the ARDS diagnosis.

  2. Step 2

    Treatment administration

    The patient receives either the investigational drug FX06 or a placebo.

    FX06 is administered as a solution for injection through an intravenous injection.

    The treatment aims to improve the time to initial unassisted breathing (UAB) until day 28.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's lung function is assessed at various time points: baseline, day 3, day 6, day 10, and day 28.

    Systemic inflammation markers such as troponin, procalcitonin, CRP, leukocyte count, ferritin, D-dimers, lactate, lactate dehydrogenase, albumin, and IL-6 are monitored.

    Other assessments include capillary refill time, duration of hospital and ICU stay, and survival/mortality rates.

  4. Step 4

    Data analysis

    Data collected from the study is analyzed to compare disease progression and improvement between the FX06 and placebo groups.

    Subgroup analyses are conducted based on factors such as concomitant medication, age, sex, and the cause of ARDS.

    Safety parameters are evaluated to ensure the safety of the treatment.

  5. Step 5

    Study conclusion

    The study is estimated to conclude by December 31, 2025.

    The primary objective is to demonstrate a difference in the time to initial unassisted breathing in patients receiving FX06 compared to those receiving placebo.

Who can join the trial?

5 criteria

  • Patients must be hospitalized with mild to moderate **Acute Respiratory Distress Syndrome (ARDS)**. This is a condition where the lungs cannot provide enough oxygen to the body's organs.
  • Patients must be at least 18 years old.
  • Patients must be randomized, which means assigned to a treatment group by chance, within 48 hours of being diagnosed with ARDS.
  • Patients or their legal representatives must provide written informed consent before any study procedures begin. This means they agree to participate after understanding the study details.
  • Patients or their legal representatives must be able to understand what the study involves and agree to participate by signing a consent form.

Who cannot join the trial?

4 criteria

  • Patients who are not experiencing Acute Respiratory Distress Syndrome (ARDS). ARDS is a serious condition where the lungs can't provide enough oxygen to the body's organs.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who are not able to breathe on their own without assistance.
  • Patients who are part of a vulnerable population, which means they might have additional health or social challenges.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

FX06 is a medication being studied for its potential to improve the condition of patients with Acute Respiratory Distress Syndrome (ARDS). The main goal of the trial is to see if FX06 can help patients start breathing on their own without assistance sooner than those who do not receive the medication. The trial will monitor patients up to 28 days to compare the effectiveness of FX06 in achieving this outcome.

What is already known about the treatment

FX06 – FX06 is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its potential to improve outcomes in patients with Acute Respiratory Distress Syndrome (ARDS). The main therapeutic indication for FX06 is to help patients with ARDS breathe without assistance sooner. At the molecular level, FX06 works by stabilizing the endothelial barrier, which helps reduce inflammation and fluid leakage in the lungs. It is classified as a peptide-based therapeutic agent.

Investigated diseases

Acute Respiratory Distress Syndrome (ARDS) – ARDS is a severe lung condition that occurs when fluid builds up in the tiny, elastic air sacs in the lungs. This fluid prevents the lungs from filling with enough air, which means less oxygen reaches the bloodstream. As a result, organs may not get the oxygen they need to function properly. The condition typically develops quickly, often within a few hours to a few days after the initial injury or infection. Common causes include pneumonia, sepsis, trauma, and inhalation of harmful substances. ARDS can lead to rapid breathing, shortness of breath, and a feeling of suffocation.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519104-27-00Protocol codeTMP-2204-2021-47Estimated enrolment263 patientsSponsorF4-Pharma Ges.m.b.H.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).