American journal of respiratory and critical care medicine
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Am. J. Respir. Crit. Care Med. · Nov 2022
Randomized Controlled TrialA Phase IIb Randomized Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis.
Rationale: Treatment options for idiopathic pulmonary fibrosis (IPF) are limited. Objectives: To evaluate the efficacy and safety of BG00011, an anti-αvβ6 IgG1 monoclonal antibody, in the treatment of patients with IPF. Methods: In a phase IIb randomized, double-blind, placebo-controlled trial, patients with IPF (FVC ⩾50% predicted, on or off background therapy) were randomized 1:1 to once-weekly subcutaneous BG00011 56 mg or placebo. ⋯ Conclusions: The results do not support the continued clinical development of BG00011. Further research is warranted to identify new treatment strategies that modify inflammatory and fibrotic pathways in IPF. Clinical trial registered with www.clinicaltrials.gov (NCT03573505).
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Am. J. Respir. Crit. Care Med. · Nov 2022
Letter Randomized Controlled TrialRandomized Phase IIa Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis.