What next?
What next?
About this study
A new drug, called Efzofitimod, is being studied in people affected by pulmonary sarcoidosis. The drug dampens immune responses with the aim of reducing inflammation and potentially preventing lung scarring from developing.
This study aims to investigate in a larger group of people whether the drug Efzofitimod could help reduce the progression of pulmonary sarcoidosis and what the side effects are.
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 assigned to one of three groups.
- Group 1 and 2 will receive a higher or lower dose of the study drug, Efzofitimod, through an intravenous infusion. This is a drip where the drug is provided directly into the bloodstream, in the form of fluids. The infusions are every 4 weeks and there are a total of 12 doses in total.
- Group 3 will receive a placebo. This is something that looks exactly like the drug, but there are no active drug ingredients in the infusions.
You will not know which group you have been assigned to until the end of the study.
The researchers will measure your lung function at different points in the study, take blood tests and ask you to complete questionnaires.
Summary of involvement
Duration up to 49 weeks
Infusions every 4 weeks, with a total of 12 doses
Infusions will either be with the study drug or a placebo
Blood tests
Questionnaires
Lung function tests
Can I take part?
You may be able to take part if you are aged between 18 and 75 years, and have a diagnosis of pulmonary sarcoidosis. You must have been receiving a stable dose of oral corticosteroids medication for at least 3 months. Your body weight must be between 40 and 160 kg.
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 research 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.
Aged 18-75 years
Diagnosis of pulmonary sarcoidosis
Experiencing symptoms of disease
Stable dose of oral corticosteroids for at least 3 months
Body weight between 40 - 160 kg
You can't be taking more than 1 oral immunosuppressant therapy
Significant pulmonary fibrosis that has increased by more than 20% within the last 12 months
Severe pulmonary hypertension
There are other specific exclusion criteria. These will be discussed with you by the research team
What difference could taking part make?
Taking part in this study will help researchers to understand if the new drug, Efzofitimod, has the potential to help people with pulmonary sarcoidosis.
Where does the study take place?
Study locations
Birmingham
Cambridge
Cottingham
Coventry
London
You may be able to take part in the study, if you do not live close to a research site, but are prepared to travel in order to take part. This will not affect you current standard treatment that you receive.
How to take part
If you would like to take part in this study or find out more information, please speak to your healthcare team to express your interest in research. You can also visit the Efzo-fit website to find out more and see if you Pre-Qualify to take part.
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.
clinicaltrials@atyrpharma.comThis study is supported by
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