What next?
What next?
About this study
People affected by pulmonary fibrosis (PF) which is linked to their rheumatic disease, currently have limited treatment options to slow the progression. New research studies are needed to gain valuable knowledge about potentially better treatment options.
This study is a randomised controlled trial which tests the impact of nerandomilast to see how this differs to a placebo, which is a lookalike medication that doesn't contain any active drug ingredients. It can sometimes be referred to as a dummy medicine.
The main aim of this study is to find out how a drug called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
You will be randomly put into one of two groups, which means it will be by chance. One group will take nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. You will take a tablet 2 times a day for 26 weeks. You will be able to continue taking your immunosuppressant treatment for your underlying rheumatic disease.
You will be asked to take part in the study for a total of about 7.5 - 13 months. During this time, you will visit the hospital or research centre (depending on location) 9-10 times. At each of these visits, you will have lung function tests (breathing tests). You will also have chest imaging at certain timepoints throughout the study. You will be asked to fill in questionnaires about your symptoms and quality of life, to understand the impact that the disease is having on you. The results between the 2 groups will be compared to understand more about the drug and see whether the treatment works. The doctors will also regularly check your health and take note of any potential unwanted side effects.
Summary of involvement
Total duration of the study is approximately 7.5 -13months
Taking a tablet twice per day for 26 weeks
Lung function tests (breathing tests)
High-Resolution Computed Tomography (HRCT) scans
Other medical tests/monitoring
Questionnaires
Can I take part?
You may be able to take part if you have systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD).
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 the main criteria list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point without this effecting your usual care or treatment.
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 out more about other research opportunities visit our research finder main page.
You are aged 18 years and older
You have a diagnosis of a systemic autoimmune rheumatic disease such as Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or Mixed connective tissue disease (MCTD)
You have fibrotic interstitial lung disease (pulmonary fibrosis)
You have been on stable treatment with immunosuppressant (IS) therapy for at least 6 months
If you are taking nintedanib, then you must have been on a stable dose for at least 12 weeks
Further inclusion criteria relating to lung function will be assessed by the researchers
You have had an acute exacerbation in the last 3 months
You have had any suicidal behaviour in the last 2 years or thoughts/ideas in the 3 months
You have been prescribed cyclophosphamide within the last 6 months, or pirfenidone within the last 8 weeks
What difference could taking part make?
At the moment there are few ways of slowing down the progression of pulmonary fibrosis. New research studies, such as this clinical trial, are needed to gain valuable knowledge to help find better and more effective treatment options for people with SARD-ILD. Taking part in research has the potential to help future people who face a diagnosis of SARD-ILD. Each research study enables us to learn more and more about the disease.
Where does the study take place?
Study locations
Antrim
Bath
Birmingham
Bristol
Leeds
Londonderry
London
Luton
Preston
Sheffield
Truro
How to take part
If you would like more information about taking part in research, please speak to your healthcare team about the options that are available to you.
Further information
This page is a summary which 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.
unitedkingdom@bitrialsupport.comThis study is supported by
This page provides a lay summary of the research study and does not contain all the information needed to inform decisions about taking part. Please speak to your medical team or the study research team in relation to specific details about the study.
Action for Pulmonary Fibrosis does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators. Every effort is made to ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org