Trial of namilumab for pulmonary sarcoidosis now fully enrolled
Topline results from Phase 2 RESOLVE-Lung study expected by year's end
The Phase 2 clinical trial RESOLVE-Lung, which is testing namilumab as a treatment for people with chronic pulmonary sarcoidosis, is now fully enrolled.
According to Kinevant Sciences, the therapy’s developer, 107 patients with hard-to-treat pulmonary sarcoidosis — disease that’s “not well-controlled despite currently available treatment” — have been recruited for the study. The first trial findings are expected by the end of the year.
“People living with pulmonary sarcoidosis clearly need new therapeutic options that can more safely and effectively control or resolve their disease,” Bill Gerhart, CEO of Kinevant, said in a company press release. “We are very hopeful about the outcome, and we look forward to reporting topline results by the end of the year.”
RESOLVE-Lung (NCT05314517), which began dosing in November, is underway across multiple sites in the U.S. and Europe. Patients are randomly assigned to receive a placebo or namilumab, administered as a subcutaneous or under-the-skin injection once monthly for about six months.
With 107 participants onboard, Kinevant’s trial is fully enrolled
The main goal of RESOLVE-Lung is to assess the proportion of patients who require rescue treatment for worsening sarcoidosis during the trial.
Additional goals include assessing the therapy’s safety and efficacy, by measuring changes in forced vital capacity, a lung function measure of how much air a person can forcibly exhale, as well as patient-reported outcomes, and corticosteroid use.
Participants who complete the study will be able to join an open-label extension in which all will be treated with namilumab for 28 weeks, or slightly longer than half a year.
The Foundation for Sarcoidosis Research, a U.S. nonprofit, supported Kinevant in its efforts to get the trial fully enrolled, according to Mary McGowan, the foundation’s CEO, who noted that “there is a need for new and better therapies to be developed.”
“Pulmonary sarcoidosis is a complex and challenging condition, with limited treatment options, and many unacceptable side effects,” McGowan said. “We are proud to have worked with Kinevant on the successful enrollment of this clinical trial. We are grateful to the sarcoidosis patient community who embraced this opportunity to lead us toward a potential new therapy as well as a deeper understanding of sarcoidosis.”
In pulmonary sarcoidosis, small clumps of immune cells, called granulomas, are found in the lungs, leading to symptoms such as shortness of breath, coughing, and decreased lung function.
While corticosteroids, such as prednisone, are standard therapies, not all patients benefit from such treatment, with symptoms worsening as the disease progresses.
Namilumab is an antibody that blocks a signaling molecule called granulocyte-macrophage colony-stimulating factor (GM-CSF) that drives the formation of granulomas and their maintenance.
Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis.
In preclinical studies with animal models, elevated levels of GM-CSF levels led to granuloma formation, scar tissue buildup, and tissue damage. By blocking GM-CSF, namilumab may be able to treat pulmonary sarcoidosis with fewer side effects compared with other therapies.
To date, more than 350 people have received namilumab, with the treatment deemed well-tolerated, per Kinevant.
“Completing enrollment for this study is an important milestone in our journey to develop a new therapy for those living with pulmonary sarcoidosis,” Gerhart said.
“I am grateful for the patients who volunteered to participate in the study, as well as for the extraordinary efforts of the Kinevant team, our industry partners, clinical trial site staff, and patient advocacy groups, all of whom came together to overcome the unique challenges of this disease to successfully enroll this study,” Gerhart added.
Kinevant is a subsidiary company of Roivant Sciences.
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