For Clinicians
Over the past decade high quality trials have transformed treatment approaches for patients with PF both by ensuring patients are not exposed to potentially harmful treatments and by supporting access to treatments with proven efficacy. Find out more in the Treatment of idiopathic pulmonary fibrosis in Australia and New Zealand: A position statement from the Thoracic Society of Australia and New Zealand and the Lung Foundation Australia, here.
Enrollment in clinical trails is now considered standard of care for patients with pulmonary fibrosis, much as it is for patients with cancer. Clinicians – be they PF ‘experts’ or not – have a vital role to play in encouraging enrollment in high quality clinical trials, especially since PF is an uncommon disease impeding recruitment to very large trials. Below are links to Pulmonary Fibrosis trials currently recruiting in Australasia.
Recruiting Trials
| Trial | Title | Status | More Information |
|---|---|---|---|
| Avalyn AP01 | A Study Evaluating the Safety and Efficacy of AP01 in Participants With Progressive Pulmonary Fibrosis (PPF) | Not recruiting | Clinicaltrials.gov ID: NCT06329401 |
| REBUILD-SM | A Randomised Clinical Trial of a digital Self-Management package for people with Interstitial Lung Disease (REBUILD-SM trial) | Not yet recruiting | Clinicaltrials.gov ID: NCT06122233 |
| CORAL | CORAL: Cough Reduction in IPF with nalbuphine ER | Recruiting | Clinicaltrials.gov ID: NCT05964335 |
| BEACON- IPF | A Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy and Safety of Bexotegrast (PLN-74809) for the Treatment of Idiopathic Pulmonary Fibrosis (BEACON-IPF) | Recruiting | Clinicaltrials.gov ID: NCT06097260 |
| Novartis LTP001 | A participant and investigator-blinded, randomized, placebo-controlled, multicentre, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis | Recruitment temporarily paused | Clinicaltrials.gov ID: NCT05497284 |
| SNDX-6352-0506 | A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects with Idiopathic Pulmonary Fibrosis (IPF) | Recruiting | Clinicaltrials.govID: NCT06132256 |
| SINFONIA | A clinical trial examining the benefits of SingINg For breathing in COPD aNd ILD pAtients | Recruiting | Trial Summary anzctr.org.au ID: Phase III -ACTRN12621001280897 |
| SHIELD | The SHIELD Whole Lung Lavage Observational Cohort Study | Recruiting | Trial Summary Clinicaltrials.gov ID: NCT05402176 |
| TELO-SCOPE | Attenuating Telomere Attrition with Danazol. Is there Scope to Dramatically Improve Health Outcomes for Adults and Children with Pulmonary Fibrosis. | Recruiting | Clinicaltrials.gov ID: NCT04638517 |
| GRIPF | Genetic research in Idiopathic Pulmonary Fibrosis (GRIPF) | Recruiting | Trial Summary Clinicaltrials.gov ID: Not applicable |
Trials Closed to Recruitment
| Trial | Title | Status | More Information |
|---|---|---|---|
| Lassen Therapeutics 1 LASN01 | A Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine the safety, tolerability, immunogenicity and pharmacokinetic properties of LASN01 in healthy subjects and in patients with idiopathic pulmonary fibrosis or thyroid eye disease | Closed to Recruitment | Clinicaltrials.gov ID: NCT05331300 |
| PFOX | PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial | Closed to Recruitment | Clinicaltrials.gov ID: NCT03737409 |
| HIIT | High intensity interval training in fibrotic interstitial lung disease | Closed to Recruitment | Clinicaltrials.gov ID: NCT03800914 |
| Boehringer Ingelheim BI 1305-0023 | A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1305-0023 over at least 52 weeks in patients with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) | Closed to Recruitment | Clinicaltrials.gov ID: NCT05321082 |
| Endeavor Biomedicines ENV-101 | A phase 2, multi-center study evaluating the safety and efficacy of ENV-101 (taladegib) in subjects with idiopathic pulmonary fibrosis (IPF) | Closed to Recruitment | Clinicaltrials.gov ID: NCT04968574 |
| Boehringer Ingelheim BI 1305-0014 | A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of Boehringer Ingelheim BI 1305-0014 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF) | Closed to Recruitment | Clinicaltrials.gov ID: NCT05321069 |
| STARSCAPE WA42293 | A phase III randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of PRM-151 in patients with Idiopathic Pulmonary Fibrosis. | Closed to Recruitment | ClinicalTrials.gov ID: NCT04552899 |
| GALACTIC-1 | A randomised, double-blind, multicentre, parallel, placebo-controlled Phase 2b study in participants with idiopathic pulmonary fibrosis (IPF) investigating the efficacy and safety of GB0139, an inhaled galectin-3 inhibitor administered via a dry powder inhaler (DPI) over 52 weeks. | Closed to Recruitment | Clinicaltrials.gov ID: NCT03832946 |
| BI 1305-0013 | A randomised, double-blind, placebo-controlled parallel group study in IPF patients over 12 weeks evaluating efficacy, safety and tolerability of BI 1015550 taken orally. | Closed to Recruitment | Clinicaltrials.gov ID: NCT04419506 |
| ATLAS AP01-002 | A Randomized Open-Label, Phase 1b Study of the Safety of Pirfenidone Solution for Inhalation (AP01) in Patients with Idiopathic Pulmonary Fibrosis | Closed to Recruitment | Clinicaltrials.gov ID: ACTRN12618001838202 |
| Trail1 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease (RAILD) | Closed to recruitment The TRAIL1 study continued enrolment through the planned timeline, but was somewhat impacted by COVID and did not meet enrolment goals. | Clinicaltrials.gov ID: NCT02808871 |
| AGN120-1 | An Open Label Study of the Efficacy, Safety and Tolerablity of Np-120 on Idiopathic Pulmonary Fibrosis and its Associated Cough | Closed to Recruitment | Clinicaltrials.gov ID: NCT04318704 |
| Zephyrus FGCL-3019-091 | FGCL-3019-091 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF). | Closed to recruitment | Clinicaltrials.gov ID: NCT03955146 |
| BMS IM027-040 | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants with Pulmonary Fibrosis. | Closed to recruitment |
Completed Trials
| Trial | Title | Status | More Information |
|---|---|---|---|
| HHF-ILD | Handheld fan for breathlessness in interstitial lung disease | Recruiting | Clinicaltrials.gov ID: ACTRN12618001838202 |
| COLDICE | Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease allianCE | Study completed | Clinicaltrials.gov ID: ACTRN12615000718549 |
Discontinued Trials
| Trial | Title | Status | More Information |
|---|---|---|---|
| SCENIC | Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial | Discontinued The SCENIC study was terminated due to the impact of COVID-19. The study was being conducted across 11 countries and while the impact was minimal in Australasia this was not the case in the other regions. |
Clinicaltrials.gov ID: NCT03864328 |
| Isabela 1&2 | A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Two Doses of GLPG1690 in Addition to Local Standard of Care for Minimum 52 Weeks in Subjects With ldiopathic Pulmonary Fibrosis | Discontinued The decision to discontinue the ISABELA Phase 3 clinical studies was based on the recommendations of the Independent Data Monitoring Committee (IDMC) which, following a regular review of unblinded data, concluded that ziritaxestat’s benefit-risk profile no longer supported continuing these studies. |
Clinicaltrials.gov ID: NCT0371l-162 Clinicaltrials.gov ID: NCT03733444 |
| Blade Therapeutics | A Phase 1a/1b, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BLD-2660 in Healthy Volunteers and Subjects with Lung Fibrosis or Liver Fibrosis | Discontinued | Clinicaltrials.gov ID: NCT03559166 |
| SPIRIT | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis (IPF) | Discontinued | Clinicaltrials.gov ID: NCT03573505 |
PACT is funded by the NHMRC Centre of Research Excellence in Pulmonary Fibrosis and generously supported by:
