Idiopathic Pulmonary FibrosisPhase 2NCT04318704
Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
A Phase 2 study testing Ifenprodil in people with Idiopathic Pulmonary Fibrosis, run by Algernon Pharmaceuticals at 6 sites in 2 countries.
Trial summary
NP-120 (Ifenprodil) has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of Idiopathic Pulmonary Fibrosis (IPF). In addition, NP-120 significantly reduced both cough frequency and onset in a guinea pig tussive model. Read more about this study
- Who is it for?
- Ages Up to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Ifenprodil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 29 Jul 2020to 10 May 2022
- 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 Up to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects with a diagnosis of IPF established during the previous seven years according to ATS/ERS/Fleischner criteria.
- Score ≥ 40 mm on the Cough Severity VAS at Screening
- Lung function parameters as follows:
- Forced Vital Capacity (FVC) ≥ 45% of the predicted value at screening.
- Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening.
- Any existing Standard of Care (SoC) treatment (e.g. pirfenidone or nintedanib) must be deemed as stable (minimum three months) before enrollment.
- Subjects must sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures.
Who cannot join
- Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.
- Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
- Has a history of malignancy within the last 2 years with the exception of basal cell carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or managed by observation, and squamous cell carcinoma if diagnosed and successfully treated more than 6 months prior to the study. SCC diagnosed with the past 6 months will be exclusionary.
- Patients experiencing cerebral hemorrhage or cerebral infarction at screening/baseline.
- Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
- Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
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- Is likely to receive lung transplantation within the next 12 months.
- Currently receiving high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan), and or investigational therapy for idiopathic pulmonary fibrosis (IPF) or administration of such therapeutics within 4 weeks of initial screening (or 5 half-lives, whichever is longer). A current dose of less than or equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated to remain stable during the study.
- Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous six months, including, but not limited to, the following:
- Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months,
- Congestive heart failure requiring hospitalization,
- Uncontrolled clinically significant arrhythmias.
- If female, the subject is pregnant or lactating or intending to become pregnant before participating in this study during the study and within (5 half- lives plus 30 days) after last dose of the study drug; or intending to donate ova during such time period.
- Women considered to be of childbearing potential who do not use highly effective birth control methods during the study.
- Known or suspected allergy to the trial drug or the relevant drugs given in the trial.
- Involvement in a clinical research study within 4 weeks prior to screening and/or prior enrollment in the study. Participation in registry studies is permitted.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia4 sites
Vale Medical Practice
Brookvale, New South Wales
Cairns Hospital
Cairns, Queensland
Concord Repatriation General Hospital
Concord, New South Wales
Westmead Hospital
Westmead, New South Wales
New Zealand2 sites
The University of Otago
Christchurch, Canterbury
Waikato Hospital
Hamilton, Waikato Region
About this study
Official title: An Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
NP-120 (Ifenprodil) has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of Idiopathic Pulmonary Fibrosis (IPF). In addition, NP-120 significantly reduced both cough frequency and onset in a guinea pig tussive model. The purpose of this proof-of-concept trial is to determine the efficacy of NP-120 in the treatment of IPF and its associated cough.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Ifenprodil
- Keywords
- Cough
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IfenprodilDrug
Ifenprodil 20 mg TID
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Active | Other | Ifenprodil Receives: Drug: Ifenprodil |
What is being measured
The primary outcome is the main question the study is designed to answer.
A ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor
Measured: Baseline and week 12 (≥11 weeks of treatment)
No worsening of force vital capacity (FVC) in either mL or % predicted
Measured: Baseline and week 12 (≥11 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start29 Jul 2020
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algernon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318704
- Sponsor's protocol ID
- AGN120-1
- Status last verified
- Mar 2022
- First submitted
- 20 Mar 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of the Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough
- ClinicalTrials.gov ID
- NCT04318704
- Acronym / sponsor ID
- AGN120-1
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Cough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Algernon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 24 Mar 2020 (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.
NP-120 (Ifenprodil) has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of Idiopathic Pulmonary Fibrosis (IPF). In addition, NP-120 significantly reduced both cough frequency and onset in a guinea pig tussive model. The purpose of this proof-of-concept trial is to determine the efficacy of NP-120 in the treatment of IPF and its associated cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Active | Other | Drug: IfenprodilIfenprodil |
Who may qualify
- Ages
- Up to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects with a diagnosis of IPF established during the previous seven years according to ATS/ERS/Fleischner criteria.
- Score ≥ 40 mm on the Cough Severity VAS at Screening
- Lung function parameters as follows:
- Any existing Standard of Care (SoC) treatment (e.g. pirfenidone or nintedanib) must be deemed as stable (minimum three months) before enrollment.
- Subjects must sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures.
Key exclusion criteria (16 listed)
- Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening.
- Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis.
- Has a history of malignancy within the last 2 years with the exception of basal cell carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or managed by observation, and squamous cell carcinoma if diagnosed and successfully treated more than 6 months prior to the study. SCC diagnosed with the past 6 months will be exclusionary.
- Patients experiencing cerebral hemorrhage or cerebral infarction at screening/baseline.
- Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years.
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 |
|---|---|---|
| IfenprodilIfenprodil 20 mg TID | Drug | Single Arm Active |
Primary outcome
A ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor
Time frame: Baseline and week 12 (≥11 weeks of treatment)
No worsening of force vital capacity (FVC) in either mL or % predicted
Time frame: Baseline and week 12 (≥11 weeks of treatment)
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 19 Jul 2022.
- 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.
6 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 Ifenprodil in people with Idiopathic Pulmonary Fibrosis, run by Algernon Pharmaceuticals at 6 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 7 inclusion and 16 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 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, New Zealand. 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. 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?
A ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor (time frame: Baseline and week 12 (≥11 weeks of treatment)). The study lists 2 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 19 Jul 2022.