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Potential of FX06 to improve disease severity in Acute Respiratory Distress Syndrome patients (Ixion 2.0)
EU CTIS ID: 2024-519104-27-00
What this study is testing
The primary objective is to demonstrate a difference in the time to initial unassisted breathing (UAB) in patients receiving FX06 compared to patients receiving placebo until day 28. Time to initial unassisted breathing (UAB) until day 28 in both treatment groups.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Hospitalised patients with mild to moderate ARDS according to the Berlin Definition of ARDS or patients with assisted breathing (without the use of PEEP) and high oxygen demand (e.g., HFNO ≥ 30 L/min) who fulfil the other criteria of the Berlin Definition of ARDS (modified Berlin criteria) (for clarification see Table 1) (Note: Patients requiring PEEP will be eligible if they fulfil the criteria of the Berlin Definition as long as they are not defined as severe ARDS according to exclusion criterion 2.)
- Patients ≥ 18 years
- Randomization within 48h of ARDS diagnosis
- Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient or his/her legal representative
- Patients or their legal representatives able to understand the requirements of the study and give written informed consent
You likely can't join if
- 1. >48 hours of invasive mechanical ventilation before randomization
- History of or current acohol or drug abuse (*1) (*1: text are additions only available in the protocol in France version FR V2.3 dated 15.01.2024)
- Protected patients (i.e. those patients under guardianship and/or curatorship) (*1) (*1: text are additions only available in the protocol in France version FR V2.3 dated 15.01.2024)
- 2. Severe ARDS according to the Berlin Definition
- Evidence of other significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases with a bad prognosis that are likely to interfere with the evaluation of the patient’s safety and with the study outcome as judged by the treating physician, e.g.: o Other severe advanced or chronic lung diseases (e.g., COPD Gold ≥ 3, severe silicosis) o Acute respiratory failure due to cardiac failure (NYHA ≥ III) or fluid overload o Pre-existing haematological disease with severe leukopenia, severe thrombocytopenia or severe anaemia (*1) o Severe renal impairment (*1) o Advanced hepatic insufficiency or severe liver disease (e.g., liver cirrhosis CHILD C) o Use of chronic (> 3 months) long-term oxygen therapy before randomization o Exacerbation of asthma o Septic shock
- Any contraindications to use the IMP (e.g., allergy or intolerance against the IMP or its ingredients)
See the full eligibility criteria
Who can join
- Hospitalised patients with mild to moderate ARDS according to the Berlin Definition of ARDS or patients with assisted breathing (without the use of PEEP) and high oxygen demand (e.g., HFNO ≥ 30 L/min) who fulfil the other criteria of the Berlin Definition of ARDS (modified Berlin criteria) (for clarification see Table 1) (Note: Patients requiring PEEP will be eligible if they fulfil the criteria of the Berlin Definition as long as they are not defined as severe ARDS according to exclusion criterion 2.)
- Patients ≥ 18 years
- Randomization within 48h of ARDS diagnosis
- Written informed consent obtained prior to the initiation of any protocol-required procedures by the patient or his/her legal representative
- Patients or their legal representatives able to understand the requirements of the study and give written informed consent
What rules you out
- 1. >48 hours of invasive mechanical ventilation before randomization
- History of or current acohol or drug abuse (*1) (*1: text are additions only available in the protocol in France version FR V2.3 dated 15.01.2024)
- Protected patients (i.e. those patients under guardianship and/or curatorship) (*1) (*1: text are additions only available in the protocol in France version FR V2.3 dated 15.01.2024)
- 2. Severe ARDS according to the Berlin Definition
- Evidence of other significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases with a bad prognosis that are likely to interfere with the evaluation of the patient’s safety and with the study outcome as judged by the treating physician, e.g.: o Other severe advanced or chronic lung diseases (e.g., COPD Gold ≥ 3, severe silicosis) o Acute respiratory failure due to cardiac failure (NYHA ≥ III) or fluid overload o Pre-existing haematological disease with severe leukopenia, severe thrombocytopenia or severe anaemia (*1) o Severe renal impairment (*1) o Advanced hepatic insufficiency or severe liver disease (e.g., liver cirrhosis CHILD C) o Use of chronic (> 3 months) long-term oxygen therapy before randomization o Exacerbation of asthma o Septic shock
- Any contraindications to use the IMP (e.g., allergy or intolerance against the IMP or its ingredients)
- Is currently being detained in an institution by a governmental or judicial order
- Do not intubate order
- Women pregnant or breastfeeding
- Males or females of reproductive potential not willing to use effective contraception for the duration of the study period (defined as PEARL index –1 - e.g., contraceptive pill, IUD or true sexual abstinence, bilateral tubal occlusion or male partner with vasectomy; also see chapter 19.2 for guidance)
- Current participation in another interventional clinical trial with IMP or participation within the last 30 days
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.