As with everything since early 2020, pulmonary fibrosis clinical trials and PACT activities have been majorly impacted by the global pandemic. We are returning to normal activities as we can.
Thank you to all involved in the ongoing clinical response to COVID-19. We are excited to continue supporting important pulmonary fibrosis trials in Australasia. To stay up to date, become a member.
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.
|Roche 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.||Recruiting|
|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.||Recruiting|
|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.||Recruiting|
|TELO-SCOPE||Attenuating Telomere Attrition with Danazol. Is there Scope to Dramatically Improve Health Outcomes for Adults and Children with Pulmonary Fibrosis.||Recruitment pending|
|Zephyrus||FGCL-3019-091 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF).||Recruiting|
|AGN120-1||An Open Label Study of the Efficacy, Safety and Tolerablity of Np-120 on Idiopathic Pulmonary Fibrosis and its Associated Cough||Recruiting||Trial Summary
Clinicaltrials.gov ID: NCT04318704
|PFOX||PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial||Recruiting||Trial SummaryClinicaltrials.gov ID: NCT03737409|
|HIIT||High intensity interval training in fibrotic interstitial lung disease||Recruiting||Trial Summary
Clinicaltrials.gov ID: NCT03800914
|GRIPF||Genetic research in Idiopathic Pulmonary Fibrosis (GRIPF)||Recruiting||Trial Summary
Trials in Follow Up
|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||Trial Summary
Clinicaltrials.gov ID: NCT04419506
|ATLAS||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||Trial Summary
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||Trial Summary Clinicaltrials.gov ID: NCT02808871|
|HHF-ILD||Handheld fan for breathlessness in interstitial lung disease||Recruiting||Trial Summary
Clinicaltrials.gov ID: ACTRN12618001838202
|COLDICE||Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease allianCE||Study completed||Trial Summary
Clinicaltrials.gov ID: ACTRN12615000718549
|SPIRIT||A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis (IPF)||Study completed||Trial Summary
Clinicaltrials.gov ID: NCT03573505
|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.
|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. Detailed data of the ISABELA studies will be presented at future medical meetings.
Clinicaltrials.gov ID: NCT03733444