ARDSPhase 2NCT03567577
Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS
A Phase 2 study testing Solnatide 25 mg powder for reconstitution for solution for inhalation and 0.9% Saline Solution in people with ARDS, run by Apeptico Forschung und Entwicklung GmbH at 15 sites in 2 countries.
Trial summary
This phase IIb, randomized, placebo-controlled, double-blind, dose escalation study will assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS and review potential efficacy endpoints for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- Solnatide 25 mg powder for reconstitution for solution for inhalation and 0.9% Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 23 May 2018to 27 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Male or female ≥18 years of age.
- Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol in Appendix I) and stable in this condition for at least 8 hours.
- Moderate-to-severe ARDS diagnosis as defined by the Berlin Definition:
- Onset of ARDS within 1 week of a known clinical insult or new or worsening respiratory symptoms.
- Bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules.
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- Respiratory failure not fully explained by cardiac failure or fluid overload (origin of oedema).
- PaO2/FiO2 ≤ 200 mm Hg with Positive End-Expiratory Pressure (PEEP) ≥5 cm H2O.
- ARDS diagnosis not older than 48 hours.
- Extravascular lung water index (EVLWI) ≥ 10 ml/PBW as assessed with a validated bedside measurement (single indicator transpulmonary thermodilution measurement with the PiCCO® system).
- Patient who meets criteria for extensive hemodynamic monitoring as per international intensive care medicine standards.
- For patients that are temporarily unable to consent (e.g. comatose patients) a subsequent informed consent has to be provided.
- Male and Female (WOCBP) patients using adequate contraception.
Who cannot join
- History of clinically relevant allergies or idiosyncrasies to solnatide.
- Known use of any other investigational or non-registered drug within 30 days prior to study enrolment.
- Severe state of septic shock with a Mean Arterial Pressure (MAP) ≤ 65 mm Hg and a serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation.
- An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g. severe malnutrition, severe neurological diseases, pulmonary fibrosis or COPD).
- Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support. In no way are patients to be denied or delayed these procedures to avoid exclusion from the study.
- Neutrophil count < 0.3 x 109/L.
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- Cancer treatment (chemotherapy or biological) or therapy with other immunosuppressive agents for organ transplantation within 2 weeks.
- Cachexia (BMI < 18.5 kg/m2).
- Cardiogenic pulmonary oedema diagnosed by echocardiography or pulmonary artery catheter.
- Severe skin burns involving more than 15% of body surface.
- Subjects who are extremely unlikely to survive more than 48 hours due to the acute conditions of the patient in the opinion of the Investigator.
- Subjects transferred from a hospital not participating in this study who are already planned to be re-transferred during the observation period.
- Subjects who are not expected to survive the next month because of an underlying uncorrectable medical condition or a do not resuscitate order.
- Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
Germany12 sites
Klinik für Operative Intensivmedizin und Intermediate Care
Aachen, North Rhine-Westphalia, 52074
Universitätsklinikum Bonn, Operative Intensivmedizin, Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin
Bonn, 53127
Klinik und Poliklinik für Anästhesiologie und Intensivtherapie / Universitätsklinikum Carl Gustav Carus
Dresden, Saxony, 01307
Georg-August-Universität Göttingen
Göttingen, 37075
Klinik für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel,
Kiel, 24105
Klinik für Anästhesiologie / Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Klinik für Anästhesiologie und operative Intensivmedizin; Universitätsmedizin Mannheim
Mannheim, 68167
Klinik für Anaesthesiologie, Klinikum der Universität München, Campus Großhadern
München, Bavaria, 81377
Klinik für Anästhesiologie und Intensivmedizin; Klinikum rechts der Isar der TU München
München, 81675
Klinik und Poliklinik für Innere Medizin II; Klinikum rechts der Isar der TU München
München, 81675
Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie; Universitätsklinikum Münster
Münster, 48149
Universitätsklinikum Würzburg, Klinik und Poliklinik für Anästhesiologie
Würzburg, 97080
Austria3 sites
Univ.-klinik f. Herz-, Thorax-, Gefäßchirurgische Anästhesiologie und lntensivmedizin, Medizinische Universität Graz
Graz, Styria, 8036
Univ. Klinik für Innere Medizin / Gem. Einrichtung für Intensiv- und Notfallmedizin/GE Medizinische Universität Innsbruck
Innsbruck, 6020
Department of Anesthesia, General Intensive Care and Pain Control,Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS - a Randomised, Placebo-controlled, Double-blind Trial
This phase IIb, randomized, placebo-controlled, double-blind, dose escalation study will assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS and review potential efficacy endpoints for a future phase III pivotal trial.
- Conditions
- ARDS
- Being tested
- Solnatide 25 mg powder for reconstitution for solution for inhalation, 0.9% Saline Solution
- Keywords
- Peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solnatide 25 mg powder for reconstitution for solution for inhalationDrug
Also called AP301
Inhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days.
0.9% Saline SolutionDrug
Inhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Solnatide 5mg | Experimental | Solnatide 25 mg powder for reconstitution for solution for inhalation. 5mg administered Receives: Drug: Solnatide 25 mg powder for reconstitution for solution for inhalation |
| Solnatide 60mg | Experimental | Solnatide 25 mg powder for reconstitution for solution for inhalation. 60mg administered Receives: Drug: Solnatide 25 mg powder for reconstitution for solution for inhalation |
| Solnatide 125mg | Experimental | Solnatide 25 mg powder for reconstitution for solution for inhalation. 125mg administered Receives: Drug: Solnatide 25 mg powder for reconstitution for solution for inhalation |
| Placebo | Placebo comparator | 0,9% saline solution Receives: Drug: 0.9% Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint: Any cause death
Primary Safety Endpoint: Composite endpoint including any cause death at day 28
Measured: Randomisation - day 28
Safety endpoint: Drug-related adverse events
Primary Safety Endpoint: Composite endpoint including drug-related adverse events through day 14
Measured: Randomisation - day 14
Safety endpoint: All adverse events
Primary Safety Endpoint: Composite endpoint including all adverse events through day 28
Measured: Randomisation - day 28
Secondary outcomes (8)
EVLWI
Change in extravascular lung water index (EVLWI) as assessed with a validated bedside measurement (measurement with the PiCCO® system)
Measured: baseline - day 7
PVPI
Change in pulmonary vascular permeability index (PVPI) as assessed with a validated bedside measurement (measurement with the PiCCO® system)
Measured: baseline - day 7
Change of ventilatory settings
Composite endpoint including ventilation mode, ventilation pressures (ventilatory plateau pressure, positive end expiratory pressure, peak inspiratory pressure, mean airway pressure, peak airway pressure, driving pressure), tidal volume
Measured: baseline - day 14
Murray lung injury score
Murray lung injury score is composed of four components: 1) chest radiograph; 2) hypoxaemia score; 3) PEEP and 4) static compliance of respiratory system. The values of the total score may range from 0 to 4. Lower values indicate a better outcome.
Measured: baseline - day 7
Oxygenation ratio (PaO2 / FiO2 ratio)
Measured: baseline - day 7
Time to extubation
Measured: baseline - day 28
Ventilator-free days (VFD)
Measured: baseline - day 28
Days of hospitalization and in ICU
Measured: baseline - day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start23 May 2018
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apeptico Forschung und Entwicklung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567577
- Sponsor's protocol ID
- AP301-II-002
- Status last verified
- May 2025
- First submitted
- 23 Apr 2018
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS - a Randomised, Placebo-controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT03567577
- Acronym / sponsor ID
- AP301-II-002
- Conditions
- ARDS
- Keywords
- Peptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Apeptico Forschung und Entwicklung GmbHIndustry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIb, randomized, placebo-controlled, double-blind, dose escalation study will assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS and review potential efficacy endpoints for a future phase III pivotal trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Solnatide 5mg | Experimental | Drug: Solnatide 25 mg powder for reconstitution for solution for inhalationSolnatide 25 mg powder for reconstitution for solution for inhalation. 5mg administered |
| Solnatide 60mg | Experimental | Drug: Solnatide 25 mg powder for reconstitution for solution for inhalationSolnatide 25 mg powder for reconstitution for solution for inhalation. 60mg administered |
| Solnatide 125mg | Experimental | Drug: Solnatide 25 mg powder for reconstitution for solution for inhalationSolnatide 25 mg powder for reconstitution for solution for inhalation. 125mg administered |
| Placebo | Placebo comparator | Drug: 0.9% Saline Solution0,9% saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Informed consent
- Male or female ≥18 years of age.
- Patient has been admitted to an ICU, is mechanically ventilated (according to the ventilation and weaning protocol in Appendix I) and stable in this condition for at least 8 hours.
- Moderate-to-severe ARDS diagnosis as defined by the Berlin Definition:
- ARDS diagnosis not older than 48 hours.
Key exclusion criteria (14 listed)
- History of clinically relevant allergies or idiosyncrasies to solnatide.
- Known use of any other investigational or non-registered drug within 30 days prior to study enrolment.
- Severe state of septic shock with a Mean Arterial Pressure (MAP) ≤ 65 mm Hg and a serum lactate level > 4 mmol/L (36 mg/dL) despite adequate volume resuscitation.
- An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g. severe malnutrition, severe neurological diseases, pulmonary fibrosis or COPD).
- Extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support. In no way are patients to be denied or delayed these procedures to avoid exclusion from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solnatide 25 mg powder for reconstitution for solution for inhalationAlso: AP301Inhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days. | Drug | Solnatide 125mg, Solnatide 5mg, Solnatide 60mg |
| 0.9% Saline SolutionInhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days. | Drug | Placebo |
Primary outcome
Safety endpoint: Any cause death
Time frame: Randomisation - day 28
Primary Safety Endpoint: Composite endpoint including any cause death at day 28
Safety endpoint: Drug-related adverse events
Time frame: Randomisation - day 14
Primary Safety Endpoint: Composite endpoint including drug-related adverse events through day 14
Safety endpoint: All adverse events
Time frame: Randomisation - day 28
Primary Safety Endpoint: Composite endpoint including all adverse events through day 28
8 secondary outcomes
EVLWI
Time frame: baseline - day 7
PVPI
Time frame: baseline - day 7
Change of ventilatory settings
Time frame: baseline - day 14
Murray lung injury score
Time frame: baseline - day 7
Oxygenation ratio (PaO2 / FiO2 ratio)
Time frame: baseline - day 7
Time to extubation
Time frame: baseline - day 28
Ventilator-free days (VFD)
Time frame: baseline - day 28
Days of hospitalization and in ICU
Time frame: baseline - day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Solnatide 25 mg powder for reconstitution for solution for inhalation and 0.9% Saline Solution in people with ARDS, run by Apeptico Forschung und Entwicklung GmbH at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoint: Any cause death (time frame: Randomisation - day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.