Gilead terminates Phase II study of simtuzumab in patients with idiopathic pulmonary fibrosis
The study's Data Monitoring Committee recommended that the study be terminated early due to lack of efficacy.
Gilead Sciences has announced that the company is stopping its Phase II clinical study of the investigational monoclonal antibody simtuzumab among patients with idiopathic pulmonary fibrosis (IPF).
This decision follows an analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC), which recommended that the study be terminated early due to lack of efficacy. Gilead has also reviewed the data and determined the study has not shown evidence of a treatment benefit in the group of patients randomized to receive simtuzumab.
Separately, Phase II studies of simtuzumab are ongoing in patients with non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The DMC for these studies also met and recommended the continuation of the studies, which have a 96-week endpoint.
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