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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
REBUILD-SM A Randomised Clinical Trial of a digital Self-Management package for people with Interstitial Lung Disease (REBUILD-SM trial) Not yet recruiting

Trial Summary

Clinicaltrials.gov ID: NCT06122233
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

Trial Summary

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 Recruiting

Trial Summary

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

Trial Summary

Clinicaltrials.govID: NCT06132256
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 Recruiting

Trial Summary

Clinicaltrials.gov ID: NCT05331300
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

Trial Summary

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
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: