Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough

NCT04318704 | Completed Phase 2

• 1 other identifier: AGN120-1
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 6

Brief 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. 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

Keywords

Cough

Outcome Measures

Primary Outcomes (2)

• A ≥50% reduction in the average number of coughs per hour over 24 hours comparing baseline to treatment period using an ambulatory cough monitor

  Baseline and week 12 (≥11 weeks of treatment)

• No worsening of force vital capacity (FVC) in either mL or % predicted

  Baseline and week 12 (≥11 weeks of treatment)

Study Arms (1)

Single Arm Active

OTHER

Ifenprodil

Drug: Ifenprodil

Interventions

Ifenprodil DRUG

Ifenprodil 20 mg TID

Single Arm Active

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Algernon Pharmaceuticals: lead

Study Sites (6)

Vale Medical Practice

Brookvale, New South Wales, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Location

Westmead Hospital

Westmead, New South Wales, Australia

Location

Cairns Hospital

Cairns, Queensland, Australia

Location

The University of Otago

Christchurch, Canterbury, New Zealand

Location

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Cough

Interventions

ifenprodil

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: July 29, 2020
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4); NZ (2)