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Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): A randomized, double-blinded, multicenter, Phase 2 study - PubMed

5 hours ago
  • #monoclonal antibody
  • #clinical trial
  • #sarcoidosis
  • Namilumab, a monoclonal antibody, was tested for treating chronic pulmonary sarcoidosis in the RESOLVE-Lung study.
  • The study was a Phase 2, randomized, double-blinded, placebo-controlled trial involving 107 participants.
  • Participants were required to stop immunosuppressive therapies and/or taper oral corticosteroids during the trial.
  • Primary endpoint was the proportion of participants needing rescue treatment due to disease worsening.
  • Namilumab showed a higher rescue event rate (37.5%) compared to placebo (23.5%), but the difference was not statistically significant (p=0.12).
  • No significant difference was observed in lung function (ppFVC) between namilumab and placebo groups.
  • Participants on namilumab were less successful in tapering oral corticosteroids (53.3%) compared to placebo (76.9%).
  • Treatment-emergent adverse events were common (94% in both groups), mostly mild or moderate.
  • The study concluded that namilumab did not provide clinical benefit for chronic pulmonary sarcoidosis.
  • The study was funded by Kinevant Sciences GmbH.