RESOLVE-Lung Study for Pulmonary Sarcoidosis

Trial Objectives

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, that works to decrease inflammation throughout the body.  Immunosuppressive and immune-modulatory therapies (IST) also are used to treat sarcoidosis.  However, these treatments do not work for everyone and are often poorly tolerated.

The RESOLVE-Lung study is evaluating the safety and effectiveness of the investigational medicine namilumab for the treatment of pulmonary sarcoidosis.  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.

Study participants will be randomly assigned to one of two groups.  Half of participants will receive the study medicine namilumab, and the other half will receive a placebo (an injection with no active ingredient).  After 2 initial doses, participants will receive subcutaneous (under the skin) injections of namilumab or placebo once monthly for 6 months.  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.  A full schedule of required study visits will be provided by the study team.