Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): a randomised, double-blinded, multicentre, phase 2 study. - 2026
Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): a randomised, double-blinded, multicentre, phase 2 study.
Van Den Blink, Bernt; Birring, Surinder S; Mogulkoc, Nesrinet al.
2026 • In European Respiratory Journal, 68 (1), p. 2501874
[en] [en] 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.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Van Den Blink, Bernt; Kinevant Sciences, Inc., New York, NY, USA
Birring, Surinder S; Centre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, Faculty of Life Sciences and Medicine, King's College London, London, UK
Mogulkoc, Nesrin; Department of Chest Diseases, University of Ege, Izmir, Turkey
Nayci Atis, Sibel; Department of Pulmonology, University of Mersin, Mersin, Turkey
Gupta, Rohit; Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA
Guiot, Julien ; Université de Liège - ULiège > Département des sciences cliniques > Pneumologie - Allergologie
Hart, Simon P ; Respiratory Research Group, Hull York Medical School/University of Hull, Cottingham, UK
Carmona Porquera, Eva M; Department of Pulmonary Medicine, Mayo Clinic, Rochester, MN, USA
Koeller, Hajira B ; Kinevant Sciences, Inc., New York, NY, USA
Arocho, Natasha; Kinevant Sciences, Inc., New York, NY, USA
Petit, Chantal M; Kinevant Sciences, Inc., New York, NY, USA
Denning, Jill; Kinevant Sciences, Inc., New York, NY, USA
Lin, Min; Roivant Sciences, Inc., New York, NY, USA
Baughman, Robert P; Department of Medicine, University of Cincinnati, Cincinnati, OH, USA
Wijsenbeek-Lourens, Marlies; Center for Interstitial Lung Diseases and Sarcoidosis, Department of Respiratory Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands
Reiss, Theodore F; Kinevant Sciences, Inc., New York, NY, USA ted.reiss@roivant.com
Safety and efficacy of namilumab for the treatment of chronic pulmonary sarcoidosis (RESOLVE-Lung): a randomised, double-blinded, multicentre, phase 2 study.
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