AzTrials
AzTrials

Respiratory Distress Syndrome, AdultPhase 3INTERESTNCT02622724

Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Patients Having Acute Respiratory Distress Syndrome (ARDS)

A Phase 3 study testing Interferon beta-1a in people with Respiratory Distress Syndrome, Adult, run by Faron Pharmaceuticals Ltd at 71 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Distress Syndrome, Adult
What is being tested?
Interferon beta-1a
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
301 participants
Where
71 sitesin 8 countries
Study dates
23 Dec 2015to 23 May 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • All patients must be intubated and mechanically ventilated to diagnose ARDS and be eligible for the study
  • Patient has a diagnosis of moderate or severe ARDS according to the Berlin definition of ARDS:
  • Acute onset of respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
  • Respiratory failure associated with known ARDS risk factors and not fully explained by either cardiac failure or fluid overload (an objective assessment of cardiac failure or fluid overload is needed if no risk factors for ARDS [moderate or severe ARDS] are present)
  • Radiological abnormalities on chest X-ray or on computerised tomography scan, i.e., bilateral opacities that are not fully explained by effusions, nodules, masses or lobar/lung collapse
  • Hypoxaemia:
Show all 13Show fewer
  • Moderate ARDS: PaO2/FiO2 >100 mmHg (>13.3 kPa) to ≤200 mmHg (≤26.6 kPa) with positive end expiratory pressure (PEEP) ≥5 cmH2O
  • Severe ARDS: PaO2/FiO2 ≤100 mmHg (≤13.3 kPa) with positive end expiratory pressure [PEEP] ≥5 centimeter of water [cmH2O]
  • The radiological and hypoxaemia criteria (1.3 and 1.4) must be met within the same 24-hour period. The time of onset of ARDS is when the last of the two specified ARDS criteria is met
  • Administration of the first dose of study drug must be planned to take place within 48 hours of moderate or severe ARDS diagnosis
  • Patient is intubated and mechanically ventilated
  • A signed informed consent form from the patient or the patient's personal legal representative or a professional legal representative must be available
  • Patient is aged ≥18 years

Who cannot join

  • Woman known to be pregnant, lactating or with a positive (urine or serum test) or indeterminate (serum test) pregnancy test
  • Patient is simultaneously taking part in another pharmacotherapy protocol
  • Patient is not expected to survive for 24 hours
  • Patient has an underlying clinical condition where, in the opinion of the Investigator, it would be extremely unlikely that the patient would come off ventilation, e.g., motor neurone disease, Duchenne muscular dystrophy or rapidly progressive interstitial pulmonary fibrosis
  • Patient has severe chronic obstructive pulmonary disease requiring long-term home oxygen therapy or mechanical ventilation (non-invasive ventilation or via tracheotomy) except for continuous positive airway pressure (CPAP) or bi-level positive airway pressure used solely for sleep-disordered breathing
  • Patient has congestive heart failure, defined as New York Heart Association class IV
Show all 14Show fewer
  • Patient has acute left ventricular failure
  • Patient has liver failure (Child-Pugh grade C)
  • Patient has received any prior interferon
  • Patient has known hypersensitivity to natural or recombinant IFN beta or to any of the excipients
  • Patient is receiving renal dialysis therapy for chronic renal failure
  • Patient is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support
  • Patient has had any form of mechanical ventilation (invasive or non-invasive, excluding CPAP alone) for longer than 48 hours prior to the diagnosis of ARDS. Non-invasive ventilation has to be continuously applied for at least 12 hours per day in these 48 hours
  • Patient has burns to ≥15% of their total body surface area

Trial locations and contacts

71 sites in 8 countries.

71 sites in 8 countries

France15 sites

  • CHU D'Angers

    Angers, Pays de la Loire Region, 49100

  • CHU Cavale Blanche

    Brest, 29609

  • Centre Hospitalier Universitaire de Bicêtre

    Le Kremlin-Bicêtre, 94270

  • Centre Hospitalier Le Mans

    Le Mans, 35033

  • Hôpital de la Croix Rousse

    Lyon, Rhône, 69004

  • Hôpital Nord AP-HM

    Marseille, 13015

  • CHRU Nancy

    Nancy, 54000

  • Centre Hospitalier Régional d'Orléans

    Orléans, Loiret, 45067

  • Pitié-Salpêtrière Hospital

    Paris, 75013

  • Hôpital Cochin, Réanimation Médicale Hospitalisation

    Paris, Île-de-France Region, 75014

  • CHU De Poitiers

    Poitiers, Poitou-Charentes, 86021

  • CHU Pontchaillou

    Rennes, 35033

  • Hôpital Charles-Nicolle

    Rouen, Seine-Maritime, 76038

  • Nouvel Hôpital Civil

    Strasbourg, Alsace, 67091

  • CHU Bretonneau

    Tours, 37044

Other trials in France

Spain15 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08026

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario del Henares

    Coslada, 28822

  • Hospital Universitario de Getafe

    Getafe, 28905

  • Hospital Universitario de Gran Canaria Dr Negrin

    Las Palmas de Gran Canaria, 35010

  • Hospital Universitario La Paz

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Corporació Sanitària Parc Taulí

    Sabadell, 08208

  • Hospital Universitari Mútua de Terrassa

    Terrassa, 08221

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

Other trials in Spain

United Kingdom14 sites

  • Bristol Royal Infirmary University Hospitals, Bristol Foundation Trust

    Bristol, BS2 8HW

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Royal Infirmary of Edinburgh

    Edinburgh, EH16 4SA

  • University College London Hospitals, NHS Foundation Trust

    London, NW1 2BU

  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 7EH

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

  • St George's University Hospitals, NHS Foundation Trust

    London, SW17 0QT

  • Hammersmith Hospital Imperial College Healthcre NHS Trust

    London, W12 0HS

  • Charing Cross Hospital St Mary's Hospital, Imperial College Healthcare NHS Trust

    London, W21NY

  • Charing Cross Hospital Imperial College Healthcare NHS Trust

    London, W6 8RF

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, NR4 7UY

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Lancashire Treaching Hospitals NHS Foundation Trust

    Preston, PR2 9HT

  • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

Germany8 sites

  • Klinikum Augsburg Klinik für Anästhesiologie

    Augsburg, 86156

  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

    Berlin, 13353

  • Universitätsklinikum Bonn Klinik und Poliklinik für Anästhesiologie

    Bonn, 53127

  • Kliniken der Stadt Köln Klinikum Merheim

    Cologne, 51109

  • Universitätsklinikum Carl Gustav Carus Klinik für Anästhesiologie und Intensivmedizin

    Dresden, 01307

  • Universitätsmedizin Göttingen Klinik für Anästhesiologie

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf Klinik für Intesivmedizin

    Hamburg, 20246

  • Universitätsklinik Leipzig Klinik und Poliklinik für Anäesthesiologie und Intensivtherapie

    Leipzig, 04103

Other trials in Germany

Belgium6 sites

  • Erasmus Hospital

    Brussels, B-1070

  • UZ Brussel

    Brussels, B-1090

  • UZ Antwerpen

    Edegem, B-2650

  • UZ Gent

    Ghent, B-9000

  • CHU Charleroi Site Hôpital Civil Marie Curie

    Lodelinsart, B-6042

  • CHU Dinant Godinne UCL Namur

    Yvoir, B-5530

Other trials in Belgium

Italy6 sites

  • Azienda Ospedaliera Universitaria Sant' Anna

    Cona, 44124

  • IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • ASST Monza

    Monza, 209000

  • Universita degli Studi di Roma "La Sapienza"

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

  • AOU Città della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Finland4 sites

  • Helsinki University Hospital

    Helsinki, FI-00290

  • Kuopio University Hospital

    Kuopio, FI-70210

  • Tampere University Hospital

    Tampere, FI-33521

  • Turku University Central Hospital

    Turku, 20520

Other trials in Finland

Czechia3 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 10034

  • Hospital Usti nad Labem

    Ústí nad Labem, 40011

Other trials in Czechia

About this study

Official title: A Phase III Double-blind, Randomised, Parallel-Group Comparison of the Efficacy and Safety of FP-1201-lyo (Recombinant Human IFN Beta-1a) and Placebo in the Treatment of Patients With Moderate or Severe Acute Respiratory Distress Syndrome

In this study effectiveness and safety of a new drug FP-1201-lyo (recombinant human interferon beta-1a) is compared to placebo. Investigation is conducted with patients who have acute respiratory distress syndrome (ARDS). The new drug is expected to reduce the time which a patient need to be on the ventilator and improve patient's chances of survival. Currently there are no approved drugs for treating moderate or severe ARDS patients.

Read the detailed description

This is a Phase III clinical study to investigate the efficacy and safety of FP-1201-lyo (recombinant human interferon [IFN] beta-1a) compared to placebo in patients diagnosed with moderate or severe acute respiratory distress syndrome (ARDS). Primary objective is to demonstrate the efficacy of FP-1201-lyo in improving the clinical course and outcome based on survival and need for mechanical ventilation. Currently there are no approved drugs for treating moderate or severe ARDS patients.

FP-1201-lyo is a lyophilised powder form of recombinant human IFN beta-1a reconstituted in water for injection and is administered intravenously.

Recombinant human IFN beta-1a is an approved treatment for patients for other indication and its safety profile in such patients is well characterised.

Being tested
Interferon beta-1a, Placebo
Keywords
ARDS, human, Acute Respiratory Distress Syndrome, Respiratory Insufficiency
Medical subject headings
Respiratory Distress Syndrome, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interferon beta-1aDrug

    Also called FP-1201-lyo, Traumakine, ATC code L03AB07

    Investigational drug

  • PlaceboDrug

    Also called FP-1201-lyo Placebo

    Placebo for investigational drug

Study groups in NCT02622724
Study groupRoleWhat they receive
FP-1201-lyo 10 μgExperimentalFP-1201-lyo 10 μg (Interferon beta-1a) will be administered once daily as an intravenous bolus injection for 6 days. Investigational product is lyophilisate for solution for injection which will be reconstituted in water for injection.
Receives: Drug: Interferon beta-1a
FP-1201-lyo PlaceboPlacebo comparatorFP-1201-lyo Placebo will be administered once daily as an intravenous bolus injection for 6 days. Investigational placebo product is lyophilisate for solution for injection which will be reconstituted in water for injection.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28

    VFDsurv is a composite measure of all-cause mortality and the number of days free of mechanical ventilation (VFDsurv) within 28 days among survivors. Ventilator-free days (VFDs) correspond to those days when unassisted breathing (UAB) was possible for a complete calendar day. UAB was defined as: spontaneously breathing with face mask, nasal prong oxygen or room air, T-piece breathing, tracheostomy mask breathing, CPAP less than or equal to 5 cmH2O without pressure support or intermittent mandatory ventilation assistance, use of CPAP or BIPAP solely for sleep apnoea management. A patient was reported as ventilator-free after 2 consecutive calendar days of unassisted breathing (a VFD value of 0 is assigned to patients who die without initiating UAB or who require more than 28 days of mechanical ventilation. All patients who die before Day28 are assigned a VFDsurv value of -1).

    Measured: Day 28

Secondary outcomes (15)

  1. Efficacy Endpoint: All-cause Mortality

    Fatalities, mortality all-causes from randomisation up to Day 28

    Measured: At Day 28

  2. Efficacy Endpoint: Mortality in ICU

    All-cause mortality for subjects who died in Intensive Care Units up to Day 28.

    Measured: Up to Day 28

  3. Efficacy Endpoint: Mortality in Hospital

    This is the number of subjects who died in hospital (i.e. outside of Intensive Care Units) up to Day 28.

    Measured: Up to Day 28

  4. Other Secondary Efficacy Endpoints: Days Free of Organ Failure

    The total number of days free of organ failure by Sequential Organ Failure Assessment (SOFA) methodology. Overall, the median number of days free of organ failure was 0 days in both the treatment groups.

    Measured: Day 28 or last day in intensive care unit [ICU] if patient has left the ICU earlier than Day 28

  5. Other Secondary Efficacy Endpoints: Days Free of Renal Support

    Days without renal support (any renal support was documented). Overall, the median number of days free of renal support was 28 days in the active group and 27 days in the placebo group.

    Measured: Day 28

  6. Other Secondary Efficacy Endpoints: Days Free of Vasoactive Support

    Days without vasoactive support. The vasoactive support included catecholamine and non-catecholamine vasopressors, inotropes and vasodilating agents.

    Overall, the median number of days free of vasoactive support was 20 days in the active group and 21 days in the placebo group.

    Measured: Day 28

  7. Other Secondary Efficacy Endpoint: Days Free of Mechanical Ventilation

    The total number of days free of mechanical ventilation has been derived from the Patient Status report recorded on each day during the 28-day period. Patients who died during this period have been assigned a value of zero. This variable differs from the calculated "Ventilation Free Days (VFD) endpoint, which contribute to the VDFsurv primary efficacy endpoint as it require additional conditions of unassisted breathing (UAB) to be met.

    Measured: Day 28

  8. Other Secondary Efficacy Endpoints: Number of ICU-free Days

    Number of Intensive Care Unit free days up to Day 28, i.e. the patient is no longer receiving care in ICU. Patients who die during this period have been assigned a value of zero for the number of ICU care free days.

    Measured: Day 28

  9. Other Secondary Efficacy Endpoints: Number of Days in Hospital

    Hospitalisation days (including the stay at Intensive Care Units). Patients who died during this period have been assigned a value of 28 for the number of days in ICU or in hospital.

    Measured: Day 28

  10. Evaluation of Safety: Adverse Events and Deaths

    Adverse events (AE) up to Day 28. Per protocol, AEs occurring after Day 28 if the investigator considered a causal relationship with the study drug as well as all deaths up to Day 360 were reported. Treatment-emergent AEs (TEAEs) were defined as AEs that begins or worsens in intensity after at least one dose of study drug has been administered. Serious AEs (SAEs) were defined as any untoward medical occurrence that at any dose resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was an important medical event.

    Measured: AEs up to Day 28, only related after Day 28 and deaths up to Day 360

  11. Efficacy Endpoint: Presence of Neutralising Antibodies to IFN Beta-1a

    The immunological response to FP-1201-lyo was assessed by monitoring presence of anti-drug binding antibodies (BAbs) and neutralising antibodies (NAbs) to IFN beta-1a on pre-dose Day 1 and at Day 28, the last day in ICU or early termination (if earlier). The BAbs were determined first, and if present, the NAbs were also determined. Presence of BAbs and NAbs were summarised categorically, using positive/negative classification.

    Measured: Baseline and Day 28 (or last day in intensive care unit [ICU] or at withdrawal, if earlier)

  12. Efficacy Endpoint: Evaluation of Pharmacodynamic (PD) Using Myxovirus Resistance Protein A (MxA) Biomarker

    Evaluation of MxA biomarker change from baseline to D14 between treatments arms over time.

    Measured: From baseline to Day 14

  13. Long-term Efficacy Endpoint: Change in Quality of Life From Baseline to Day 180

    Quality of Life was assessed through EQ-5D-3L (EuroQol 5-Dimensions 3-Levels questionnaire). An EQ Visual Analogue Scale (VAS) total score (ranging from 0-100) was measured (0= Worst imaginable health state, 100= Best imaginable health state). The EQ-5D-3L VAS scores are numerically summarised as change from pre-dose (Day 1) to long term follow-up (Day 180 visit).

    Measured: Change from baseline to Day 180

  14. Long-term Efficacy Endpoints Relating to Respiratory Functioning (FEV1)

    Measuring FEV1 (forced expiratory volume in 1 second) assessed pulmonary function (airway obstruction, bronchoconstriction or bronchodilation). FEV1 is the volume exhaled during the first second of a forced expiratory manoeuvre, starting from the level of total lung capacity.

    Measured: Day 180

  15. Long-term Efficacy Endpoints Relating to Neurological Functioning (6MWT)

    The 6-minute walk test (6MWT) measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. According to the ERS/ATS technical standard to which the 6MWT was done, the walk test is done twice and the best result is used. It is an evaluation of the global and integrated responses of all systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood and neuromuscular units and muscle metabolism. The self-paced 6MWT assesses the sub- maximal level of functional capacity and will better reflect the functional exercise level for daily activities. ANOVA parameters estimates (LS Means and 90 % conf.interval) for the overall treatment difference was analysed.

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2015 (estimated)
  2. Study start23 Dec 2015
  3. Primary completion17 May 2018
  4. Study completion23 May 2018

Why it stopped: Day 90 results indicate IMP did not reduce mortality or ventilator free days

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02622724
Sponsor's protocol ID
FPCLI002
Other IDs
2014-005260-15, 2014
Acronym
INTEREST
Status last verified
Mar 2020
First submitted
24 Nov 2015
Last updated
30 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jalkanen J, Khan S, Elima K, Huttunen T, Wang N, Hollmen M, Elo LL, Jalkanen S. Polymorphism in interferon alpha/beta receptor contributes to glucocorticoid response and outcome of ARDS and COVID-19. Crit Care. 2023 Mar 16;27(1):112. doi: 10.1186/s13054-023-04388-8.

    PubMed 36927455

  • Ranieri VM, Pettila V, Karvonen MK, Jalkanen J, Nightingale P, Brealey D, Mancebo J, Ferrer R, Mercat A, Patroniti N, Quintel M, Vincent JL, Okkonen M, Meziani F, Bellani G, MacCallum N, Creteur J, Kluge S, Artigas-Raventos A, Maksimow M, Piippo I, Elima K, Jalkanen S, Jalkanen M, Bellingan G; INTEREST Study Group. Effect of Intravenous Interferon beta-1a on Death and Days Free From Mechanical Ventilation Among Patients With Moderate to Severe Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2020 Feb 25;323(8):725-733. doi: 10.1001/jama.2019.22525.

    PubMed 32065831

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon beta-1a in people with Respiratory Distress Syndrome, Adult, run by Faron Pharmaceuticals Ltd at 71 sites in 8 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: stopped early, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in France, Spain, United Kingdom, Germany, Belgium and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02622724, which also lists 2 linked publications.

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 30 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in