Zephyrus II: Phase 3 study investigating the safety and effectiveness of a new drug, Pamrevlumab, for patients with IPF

Upcoming study
Expected to open September 2020
This study is currently recruiting
Expected to close April 2023
This study is closed
This study closed in April 2023
We will update this page with study results when available.
Information on study results are included below
This study closed in April 2023

What next?

FibroGen have announced the topline results for their Phase 3 clinical trial, ZEPHYRUS-1, which was the study of Pamrevlumab for the treatment of IPF. Sadly, the study did not meet the primary endpoints of a change in lung function in patients taking the trial drug.

ZEPHYRUS-1 was a phase 3 clinical trial which was testing whether a potential new drug, called Pamrevlumab, could help treat IPF. The study was a randomised control trial, where 2 groups of participants were given different treatments over a 48 week period. Group 1 were given the study drug, whereas group 2 were given a placebo, which did not contain any of the active medication.

This news is disappointing for the PF community, but knowing which drugs do not work is also important progress.  We want to extend our thanks to the people who took part in the study, along with the researchers and clinicians.  

The study found that the drug was generally safe and well tolerated, but it did not improve lung function or patient’s symptoms. The study compared Forced Vital Capacity (FVC) between both groups, and found that both groups got worse over time in a similar way.  

Based on the results, FibroGen have made the decision to stop the study.

We are deeply disappointed that these results do not support pamrevlumab as a new treatment for IPF. FibroGen would like to thank the patients and clinical trial investigators for their dedication to participating in this study.

Mark D. Eisner, MD, MPH, Chief Medical Officer, FibroGen.

Around the world researchers are trying to find better treatments for patients with PF and many exciting projects are happening now.

If you would like to help scientists find potential new treatments, you can talk to your clinical team about opportunities to take part in research today.

Original listing:

What next?

FibroGen have announced the topline results for their Phase 3 clinical trial, ZEPHYRUS-1, which was the study of Pamrevlumab for the treatment of IPF. Sadly, the study did not meet the primary endpoints of a change in lung function in patients taking the trial drug.

ZEPHYRUS-1 was a phase 3 clinical trial which was testing whether a potential new drug, called Pamrevlumab, could help treat IPF. The study was a randomised control trial, where 2 groups of participants were given different treatments over a 48 week period. Group 1 were given the study drug, whereas group 2 were given a placebo, which did not contain any of the active medication.

This news is disappointing for the PF community, but knowing which drugs do not work is also important progress.  We want to extend our thanks to the people who took part in the study, along with the researchers and clinicians.  

The study found that the drug was generally safe and well tolerated, but it did not improve lung function or patient’s symptoms. The study compared Forced Vital Capacity (FVC) between both groups, and found that both groups got worse over time in a similar way.  

Based on the results, FibroGen have made the decision to stop the study.

We are deeply disappointed that these results do not support pamrevlumab as a new treatment for IPF. FibroGen would like to thank the patients and clinical trial investigators for their dedication to participating in this study.

Mark D. Eisner, MD, MPH, Chief Medical Officer, FibroGen.

Around the world researchers are trying to find better treatments for patients with PF and many exciting projects are happening now.

If you would like to help scientists find potential new treatments, you can talk to your clinical team about opportunities to take part in research today.

Original listing:

About this study

The Zephyrus II study is randomised control trial where patients will receive a drip (intravenous infusion) of either the drug, Pamrevlumab, or a placebo, every 3 weeks. There are a total of up to 17 infusions over a period of 48 weeks.

The aim of the study is to understand if the effect of the new drug for people with IPF, and if there is an impact on lung function over time.

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What is involved?

You will be randomly assigned to one of two groups. One group will receive the study drug, Pamrevlumab. Whereas the other group will receive a placebo, which does not contain any active drug ingredients and is a lookalike medications. Both treatments are given as fluids through a drip, every 3 weeks.

You will have a total of up to 17 infusions over 48 weeks. Participants will know if they are receiving the drug or the placebo. For those who complete the 48 week study, they will be eligible for an optional extension phase of the study to continue accessing the study drug including those who initially received the placebo.

Throughout the study, various parameters will be measured. Lung function tests, hospitalisation, exacerbation and mortality data will be monitored.

Summary of involvement

Intravenous infusion every 3 weeks

Initial study duration 48 weeks, with the option for a further 48 week extension

Lung function tests

Medical assessments

Can I take part?

You may be able to take part in the study if you have a diagnosis of IPF and are not currently receiving treatment for IPF with an approved therapy.

In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.

If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.

To find our more about other research opportunities visit our research finder main page.

You may be able to join this study if all of these apply:

Aged 40 to 85 years

Diagnosis of IPF

Not currently receiving treatment for IPF with an approved therapy (pirfenidone or nintedanib)

There is a set criteria for lung function requirements, which will be assessed by the researchers

You will not be able to join the study of any of the following applies:

Previous use of pamrevlumab

Female participants who are pregnant or breast feeding

Current or previous smoker within the previous 3 months

Interstitial lung disease other than IPF

Sustained improvement of IPF in the past 12 months

Other respiratory diseases

Acute exacerbation within the last 4 weeks

History of an allergic reaction to human, chimeric or murine monoclonal antibodies

What difference could taking part make?

People affected by idiopathic pulmonary fibrosis (IPF) currently have limited treatment options to slow the progression of disease. New research studies, such as this one, are needed to gain valuable knowledge about potentially better treatment options.

Taking part in this study will help researchers to understand if Zamrevlumab could be an effective treatment for patients with IPF. The study will help to gain greater understanding of the medication and if it has the potential to help reduce the progression of lung scarring.

Taking part in research has the potential to make a difference for people who have PF now and for future generations.

Where does the study take place?

Study locations

Kent

Birmingham

Cambridge

Harlow

London

Manchester

Southampton

How to take part

To take part, please speak to your medical team regarding this study.

Further information

The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.

If you have any questions about this research study, please speak to your medical team and contact the researchers directly via:

zephyrus@fibrogen.com

This study is supported by

FibroGen
Study ID number:
NCT04419558

APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.

Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org