Both doses of baricitinib met the primary end point, demonstrating statistically significant improvement in scalp hair regrowth compared with placebo.
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Findings showed that the trial did not meet statistical significance on the primary endpoint.
Results from 2 studies show statistically significant improvement in scalp hair regrowth with baricitinib, a JAK inhibitor.
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.
The applications are supported by data from two 2two phase 3 induction studies and one 1 maintenance study.
Methods to prevent and treat COVID-19 in cancer patients have had to evolve alongside the SARS-CoV-2 virus.
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.