The European respiratory journal · 2026
Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): a randomised, double-blinded, multicentre, phase 2 study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Van Den Blink Bernt, Birring Surinder S, Mogulkoc Nesrin, Nayci Atis Sibel, Gupta Rohit, Guiot Julien, Hart Simon P, Carmona Porquera Eva M, Koeller Hajira B, Arocho Natasha, Petit Chantal M, Denning Jill, Lin Min, Baughman Robert P, Wijsenbeek-Lourens Marlies, Reiss Theodore F, RESOLVE-Lung investigators
Аннотация
BACKGROUND: Treatment options for chronic pulmonary sarcoidosis are limited in efficacy and by tolerability concerns. Namilumab, an investigational humanised monoclonal antibody inhibiting granulocyte-macrophage colony-stimulating factor, was hypothesised to downregulate the granulomatous response in pulmonary sarcoidosis.
METHODS: RESOLVE-Lung was a double-blind, placebo-controlled trial in participants with chronic active pulmonary sarcoidosis on oral corticosteroids (OCS) and/or immunosuppressive therapies (IST). Participants were randomised (1:1) to receive 150 mg namilumab or placebo via subcutaneous injection every 4 weeks and were required to stop IST and/or taper OCS. End-points were assessed at week 26. The primary end-point was the proportion of participants with a rescue event, such as disease worsening necessitating treatment. Secondary end-points included safety, lung function assessments and corticosteroid burden. The trial was registered at ClinicalTrials.gov (NCT05314517).
RESULTS: Of 209 participants screened, 107 were randomised to receive namilumab (n=53) or placebo (n=54). The proportion of participants with a rescue event was higher for the namilumab group (37.5%) compared with the placebo group (23.5%) (stratified difference 13.6 (90% CI -1.5-28.7) percentage points; p=0.12). The least squares (LS) mean change from baseline in forced vital capacity % predicted was -3.3 (90% CI -5.1- -1.5) percentage points for namilumab and -2.9 (90% CI -4.5- -1.3) percentage points for placebo (LS mean difference -0.4 (90% CI -2.7-2.0) percentage points). The proportion of participants successfully achieving OCS taper was 53.3% for namilumab and 76.9% for placebo (difference -19.4 (90% CI -47.5-8.7) percentage points). Treatment-emergent adverse events were reported in 94% in both groups, most being mild or moderate in severity.
CONCLUSION: In participants with chronic active pulmonary sarcoidosis, namilumab did not provide clinical benefit.
METHODS: RESOLVE-Lung was a double-blind, placebo-controlled trial in participants with chronic active pulmonary sarcoidosis on oral corticosteroids (OCS) and/or immunosuppressive therapies (IST). Participants were randomised (1:1) to receive 150 mg namilumab or placebo via subcutaneous injection every 4 weeks and were required to stop IST and/or taper OCS. End-points were assessed at week 26. The primary end-point was the proportion of participants with a rescue event, such as disease worsening necessitating treatment. Secondary end-points included safety, lung function assessments and corticosteroid burden. The trial was registered at ClinicalTrials.gov (NCT05314517).
RESULTS: Of 209 participants screened, 107 were randomised to receive namilumab (n=53) or placebo (n=54). The proportion of participants with a rescue event was higher for the namilumab group (37.5%) compared with the placebo group (23.5%) (stratified difference 13.6 (90% CI -1.5-28.7) percentage points; p=0.12). The least squares (LS) mean change from baseline in forced vital capacity % predicted was -3.3 (90% CI -5.1- -1.5) percentage points for namilumab and -2.9 (90% CI -4.5- -1.3) percentage points for placebo (LS mean difference -0.4 (90% CI -2.7-2.0) percentage points). The proportion of participants successfully achieving OCS taper was 53.3% for namilumab and 76.9% for placebo (difference -19.4 (90% CI -47.5-8.7) percentage points). Treatment-emergent adverse events were reported in 94% in both groups, most being mild or moderate in severity.
CONCLUSION: In participants with chronic active pulmonary sarcoidosis, namilumab did not provide clinical benefit.