What is Sarcoidosis?
Sarcoidosis is a rare inflammatory disease characterized by the presence of tiny clumps of immune cells, called granulomas, that can occur in any organ or tissue. The cause of sarcoidosis is unknown. It is believed to be the result of an uncontrolled immune response, and it may also have a genetic (inherited) component. Sarcoidosis typically gets better with little or no treatment, but in about half of all patients, the granulomas do not go away, leading to poor quality of life, organ dysfunction, and potentially organ failure.
Sarcoidosis most commonly affects the lungs and lymph nodes, but it can also affect the eyes, skin, heart, and other organs. Sarcoidosis that primarily affects the lungs is called pulmonary sarcoidosis. Symptoms of pulmonary sarcoidosis may include fatigue, shortness of breath, coughing, and decreased lung function. These symptoms develop gradually, and for some people may continue over time and get worse despite treatment (chronic pulmonary sarcoidosis).
There is a significant need for more effective and better tolerated therapies for treating pulmonary sarcoidosis.
Initial treatment for pulmonary sarcoidosis is usually an oral corticosteroid, such as prednisone, which works to decrease inflammation throughout the body. Immunosuppressive and immune- modulatory therapies (IST) are also used to treat sarcoidosis. However, these treatments do not work for everyone and are often poorly tolerated.
About the RESOLVE-Lung Study
The RESOLVE-Lung study is evaluating the safety and effectiveness of the investigational medicine namilumab for the treatment of pulmonary sarcoidosis. Up to 100 participants will be enrolled at study sites in the United States and Europe.
Participants will initially receive once monthly injections of namilumab or placebo (injection with no active ingredient) for about 6 months. Participants will be randomly assigned to one of two groups, and neither participants nor the study doctor will know which has been assigned.
After the initial treatment period, all participants will have the option to receive namilumab in a 6-month open-label extension, regardless of whether they were initially assigned namilumab or placebo.
About Namilumab
Namilumab is a human monoclonal antibody (mAb) believed to treat the underlying cause of sarcoidosis by inhibiting one of the key proteins responsible for the formation of sarcoidosis granulomas. Namilumab has been studied previously in over 300 people and was found to be well-tolerated. It is considered investigational because it is not yet approved by the US Food and Drug Administration (or any other health authority) for any disease or condition.
Namilumab is given as a subcutaneous (under the skin) injection by a trained healthcare professional.
Who Can Participate?
This study may be an option for adults 18 years of age and older who meet the following requirements:
- Diagnosed with pulmonary sarcoidosis at least 6 months ago, and experiencing symptoms related to your pulmonary sarcoidosis.
- Vaccinated for COVID-19 at least 2 weeks ago (defined as completion of the primary series).
- If taking a corticosteroid (e.g. prednisone): On a stable dose of 25 mg/day or less for at least 4 weeks and are willing to reduce their dose under medical supervision throughout the study.
- If taking immunosuppressant therapy (e.g. methotrexate): Willing to stop immunosuppressant therapy if enrolled in the study.
For a complete list of criteria and more information about participating in the RESOLVE-Lung Study, please answer a few questions to connect with a study site near you.
What To Expect
If this study is a good fit for you, and you decide to participate, you will be randomly assigned to one of two groups. Neither you nor the study doctor will know which group you have been assigned to. One group will receive the study medicine namilumab, and the other group will receive a placebo.
Although namilumab has been well-tolerated in studies so far, it is possible that you may experience side effects such as influenza- like illness, runny nose, or headache. The study doctor will discuss all possible side effects with you and will closely monitor your health throughout the study.
If you are currently taking a corticosteroid for your pulmonary sarcoidosis, the study doctor will attempt to decrease your dose to 5 mg or less throughout the course of the study. If you are taking immunosuppressive therapy (IST), you will be asked to stop at the start of the study.
After 2 initial subcutaneous (under the skin) injections of namilumab or placebo on Day 1 and Day 15 of the study, you will receive once monthly injections for the next 6 months. During this 6-month treatment period, you will need to attend regular study visits. The study team will discuss with you the best location to complete these visits, which may be a combination of in the clinic, telephone/telemedicine, or at your home.
A complete list of visits and study assessments will be provided to you by the study team.
Why Participate?
Clinical trials offer opportunities for patients to partner with researchers to help develop new treatments for serious diseases.
Possible benefits from taking part in the RESOLVE-Lung study may include:
- Access to the study medicine namilumab
- Relief of, or lessening of, the signs and symptoms of your pulmonary sarcoidosis
- Increased monitoring of your pulmonary sarcoidosis with a specialist provider
- Contributing to research which may help others with pulmonary sarcoidosis in the future
- There is no guarantee that you will experience any benefit
If you are a member of a racial or ethnic group historically underrepresented in clinical trials, participating in a clinical trial will help ensure the results better reflect the effectiveness and safety of a new therapy for everyone with pulmonary sarcoidosis.
Open-Label Extension
After the initial treatment period, all participants will have the option to receive namilumab in a 6-month open-label extension, regardless of whether they were initially assigned namilumab or placebo.
If you decide to participate in the open-label extension, the study team will provide more information and an updated study visit schedule.
Frequently Asked Questions
What is the purpose of the RESOLVE-Lung study?
The purpose of this study is to determine if namilumab is safe and effective for the treatment of pulmonary sarcoidosis.
What are the chances of receiving namilumab versus placebo?
There is an equal chance of receiving namilumab or placebo during the 6-month double-blind period. All participants who complete the 6-month double-blind treatment period are eligible to receive namilumab during a 6-month open-label extension period.
What are the possible side effects?
Namilumab has been well-tolerated in studies so far, with the most common side effects reported being influenza-like illness, runny nose, headache, temporary increases in liver function tests, and decreases in white blood cell count.
Because of the way namilumab works in the body, other possible side effects that could occur include infection, allergic reactions, and injection site soreness. A rare lung condition called pulmonary alveolar proteinosis is possible, but this has not been seen in any patients or volunteers to date.
There may be other side effects of namilumab that are not known at this time. Your study doctor will discuss with you the full list of potential risks of participating in the RESOLVE-Lung study.
How long will I be in the study?
If you are not participating in the open-label extension: About 11 months
If you are participating in the open-label extension: About 18 months
What if I change my mind about participating?
You can choose to leave the study at any time, for any reason. Choosing to leave the study will not impact your regular sarcoidosis treatment or future medical care.
Can I continue taking my sarcoidosis medication(s) during the RESOLVE-Lung study?
If you are taking a corticosteroid, the study doctor will attempt to decrease your dose to 5 mg or less throughout the course of the study. If you are taking immunosuppressive therapy (IST), you will be asked to stop at the start of the study. Other medications may be allowed. Please speak with the study doctor about your current medications and any concerns you may have.
Is there a cost to participate in the RESOLVE-Lung study?
No. Participants will not have to pay for the study medicine, study visits, or for the procedures or tests that are needed as part of this study.
Does the study sponsor offer any financial assistance for trial participation?
Travel and other study-related expenses may be covered by the study sponsor. The process for reimbursement may vary by study site. Please speak with a member of your study team for more information.