What next?
What next?
About this study
Treatments remain limited for people with pulmonary sarcoidosis. Initial treatment often involves taking corticosteroids which can help to reduce inflammation in the body. Some people are also prescribed immunosuppressant drugs. These treatments aren't always effective and can lead to unwanted side effects. Better and more effective treatments are needed.
The RESOLVE-Lung study is looking at a potential new drug, called namilumab. This drug is a human monoclonal antibody (mAB) that researchers think could help to treat the underlying cause of the disease. It works by stopping one of the key proteins that forms sarcoidosis granulomas. The study aims to find out how the body responds to the drug and if it is effective for helping people with pulmonary sarcoidosis.
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 two groups.
- Group 1 will receive the study drug, namilumab, through an injection. The injections are every month for six months.
- Group 2 will receive a placebo injection. This is something that looks exactly like the drug, but there are no active drug ingredients in the injections.
You will not know which group you have been assigned to until the end of the study. After the study has finished, regardless of which group you were in, you will be given the option to take namilumab for an additional six months, if you would like to.
The researchers will measure your lung function at different points in the study, take blood tests and ask you to complete questionnaires to see if there are any benefits for taking the drug and potential side effects.
Summary of involvement
Monthly injections for 6 months
Lung function tests
Other medical assessments
Questionnaires
Can I take part?
You may be able to take part if you are over the age of 18 years and have a diagnosis of pulmonary sarcoidosis.
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.
Diagnosis of pulmonary sarcoidosis at least 6 months ago
Aged 18 years and over
Body Mass Index (BMI) of less than 40 kg/m2
Vaccinated against COVID-19 at least 2 weeks before the start of the study
If taking corticosteroid medication, such as prednisone, you must be on a stable dose of 25 mg/day or less. Or willing to reduce the dose when taking part in the study
You cannot take part if you have been in hospital due to respiratory illness 30 days before the study starts
Women who are pregnant or breastfeeding
Extremely low or high blood pressure
Receiving immunosuppressant therapy, such as methotrexate. However, you may be able to take part if willing to stop this during the study
What difference could taking part make?
Taking part in this study will help researchers to understand if the new drug, namilumab, has the potential to help people with pulmonary sarcoidosis.
Taking part in research not only helps researcher now, but it helps those affected by the disease in the future. All research leads us to finding better and more effective treatment options, by figuring out what does and doesn't work.
Where does the study take place?
Study locations
Cambridge
Cottingham
London
You may be able to take part in the study if you do not live close to the study locations, but are willing and able to travel to the sites. Travel and other expenses may be covered by the sponsors of the study, but this must be discussed with the research team.
How to take part
If you would like to find out more about taking part or what research opportunities are available for you, we would encourage you to ask your healthcare team.
You can also find out more about the study on the Sarcoidosis Trial website, where you can also answer a set to questions to see if you may qualify taking part in the 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.
kinevant.resolve-lung@kinevant.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