Clinical trial testing new drug for rare lung condition opens at Cambridge

People with pulmonary sarcoidosis are being invited to take part in an international clinical trial at Cambridge University Hospitals NHS Foundation Trust (CUH).

The RESOLVE-Lung study is evaluating the safety and effectiveness of a new drug, namilumab, in the treatment of pulmonary sarcoidosis.

Sarcoidosis is a rare inflammatory disease which causes granulomas, tiny clumps of immune cells, to form in any organ or tissue. When it occurs in the lungs it is known as pulmonary sarcoidosis.

Although it most commonly affects the lungs, it can also affect the skin, eyes, joints, nervous system, heart and other parts of the body.

The main symptoms of pulmonary sarcoidosis are shortness of breath and a persistent dry cough, and some people experience pain and discomfort in their chest.

Namilumab is a targeted drug designed to block a molecule which promotes inflammation, thought to be involved in granuloma formation and maintenance. Namilumab has not yet been approved by any health authority for any disease or condition.

Participants in the RESOLVE-Lung study will initially receive monthly injections of namilumab or a placebo (a substance with no therapeutic effect) for approximately six months.

After the initial treatment period, all participants will have the option to receive namilumab for another six months, regardless of whether they initially received namilumab or a placebo.

Up to 100 participants will be enrolled at study sites in the United Kingdom, Europe and the United States.

Dr Akhilesh Jha and Dr Theresia Mikolasch, Co-Principal Investigators of the RESOLVE-Lung study at CUH, said:

“Sarcoidosis is a disease that can cause inflammation and scarring of the lungs and is often treated with oral steroids, which are known to have significant side effects.

“The RESOLVE-Lung trial aims to investigate a new treatment for sarcoidosis, which will target inflammation more precisely, and if successful, will provide an alternative option to steroids.

“We are grateful if people with sarcoidosis and clinicians looking after them would consider participating in the study.”

Dr Helen Macdonald, Chief Operating Officer at the NIHR Clinical Research Network East of England, said:

“It’s only through research that we can find new treatments for managing long-term conditions such as sarcoidosis. We are hugely grateful to people in the East of England who participate in research, including patients, staff and supporters alike.”

To find out more about the RESOLVE-Lung study, please visit www.sarcoidosistrial.com/en-uk.