Namilumab for Chronic Pulmonary Sarcoidosis
(RESOLVE-Lung Trial)
Trial Summary
What is the purpose of this trial?
This trial tests namilumab, an injectable medication, on study participants. Namilumab works with the immune system to manage symptoms or treat a disease.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants who are treatment naive (not currently on treatment) are excluded, which suggests that continuing some medications might be allowed. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the drug Namilumab for treating chronic pulmonary sarcoidosis?
Namilumab has shown safety and effectiveness in treating rheumatoid arthritis, a condition involving inflammation, by targeting GM-CSF, a protein involved in immune responses. While not directly tested for sarcoidosis, similar drugs like infliximab have been effective in treating sarcoidosis, suggesting potential for Namilumab.12345
How is the drug namilumab different from other treatments for chronic pulmonary sarcoidosis?
Research Team
Ted Reiss, MD
Principal Investigator
Kinevant Sciences
Eligibility Criteria
Adults over 18 with chronic pulmonary sarcoidosis, a BMI under 40, and difficulty breathing can join this trial. They must have completed their primary COVID-19 vaccination series at least two weeks before joining and have a history of sarcoidosis confirmed by medical records and tests. Pregnant or breastfeeding women, those with severe lung fibrosis or recent serious respiratory illness, high blood pressure extremes, other major diseases, or who are treatment naive cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive namilumab or placebo subcutaneously every 4 weeks for 26 weeks
Open-label Extension
Participants may continue to receive namilumab for an additional 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Namilumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kinevant Sciences GmbH
Lead Sponsor