RESOLVE-Lung Study for Pulmonary Sarcoidosis

 

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



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

Co-Investigators


Request More Information

By completing this form, you agree to learn more about this study and see if you qualify.


*
*
*
*
 I would also like to receive periodic emails with health information, news and clinical research updates from National Jewish Health: