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For Clinicians

PACT Update

As with everything since early 2020, pulmonary fibrosis clinical trials and PACT activities have been majorly impacted by the global pandemic. We are continuing to operate as normally as possible during this challenging time. 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.

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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
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

Trial Summary 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. Recruiting

Trial Summary ID: NCT03832946
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

Trial Summary ID: NCT04308681
TELO-SCOPE Attenuating Telomere Attrition with Danazol. Is there Scope to Dramatically Improve Health Outcomes for Adults and Children with Pulmonary Fibrosis. Recruitment pending

Trial Summary ID: NCT04638517
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

Trial Summary ID: NCT03955146
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 ID: NCT04318704

PFOX PFOX: Pulmonary Fibrosis Ambulatory Oxygen Trial Recruiting Trial Summary ID: NCT03737409
HIIT High intensity interval training in fibrotic interstitial lung disease Recruiting Trial Summary ID: NCT03800914

GRIPF Genetic research in Idiopathic Pulmonary Fibrosis (GRIPF) Recruiting Trial Summary

Not applicable

Trials in Follow Up

Trial Title Status More Information
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 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 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 ID: NCT02808871

Completed Trials

Trial Title Status More Information
HHF-ILD Handheld fan for breathlessness in interstitial lung disease Recruiting Trial Summary ID: ACTRN12618001838202

COLDICE Cryobiopsy versus Open Lung biopsy in the Diagnosis of Interstitial lung disease allianCE Study completed Trial Summary 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 ID: NCT03573505

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.

Trial Summary 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.

Trial Summary ID: NCT0371l-162 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 ID: NCT03559166

PACT is funded by the NHMRC Centre of Research Excellence in Pulmonary Fibrosis and generously supported by: