RESOLVE-Lung Study for Pulmonary Sarcoidosis Request More Information Trial Objective 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. Enrollment Active Clinical Trials Currently Recruiting Who Can Participate People diagnosed with chronic pulmonary sarcoidosis for at least six months, who have experienced symptoms related to their pulmonary sarcoidosis in the past 6 months, and are not well controlled by oral corticosteroids and/or immunosuppressive therapy. Study participants are also required to have received vaccination for COVID-19 (defined as completion of the primary series). Age: 18+ Gender: Any Gender Estimated Time Commitment Approximately 36 weeks × Payments are intended to compensate the participant for their time and effort during the study. Payments are typically given to the participant at the end of each completed study visit. Reimbursements are intended to compensate the participant for travel-related expenses. They must be approved by the study staff and require you to turn in receipts. Travel reimbursement will vary from study to study. Payment & Reimbursement Payment: Provided Travel Reimbursement: Available Trial Contact For more information, contact: Kris Eliopoulos 303.270.2622 Request More Information Trial Location National Jewish Main Campus, Denver, CO Trial Sponsors Kinevant Sciences GmbH Principal Investigators Clara Restrepo, MD + × Clara Restrepo, MD Associate Professor Director, Sleep Laboratory Division of Environmental & Occupational Health Sciences Department of Medicine View Full Profile Patient Rating 4.8 out of 5 stars Make an Appoinment Co-Investigators Lisa Maier, MD, MSPH, FCCP + × Lisa Maier, MD, MSPH, FCCP Professor Director, Division of Env & Occ Health Science Core Clinical Lab Chief, Division of Environmental & Occupational Health Sciences Department of Medicine View Full Profile Patient Rating 4.9 out of 5 stars Make an Appoinment Shu-Yi Liao, MD, MPH, ScD + × Shu-Yi Liao, MD, MPH, ScD Assistant Professor Division of Environmental & Occupational Health Sciences Department of Medicine View Full Profile Patient Rating 4.7 out of 5 stars Make an Appoinment Request More Information By completing this form, you agree to learn more about this study and see if you qualify. First Name:* Last Name:* Email Address:* Phone:* I would also like to receive periodic emails with health information, news and clinical research updates from National Jewish Health: YesNo
Trial Objective 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.