Eli Lilly plans to conduct a phase-3 clinical trial on baricitinib (under the trade name of Olumiant, LY3009104) to treat atopic dermatitis in Korea. Baricitinib is an autoimmune disease treatment agent.

The Ministry of Food and Drug Administration on Monday approved the plan for the trial, submitted by the company’s Korean unit, Lilly Korea.

The global trial will test the baricitinib’s long-term safety and efficacy in adult patients with atopic dermatitis. The study will be phase-3, multicenter, and double-blind.

A total of 1,170 patients worldwide will participate in the study, which is scheduled to be completed by March 9, 2021, according to Lilly Korea.

In Korea, 37 patients with moderate to severe atopic dermatitis will participate in the trial at Catholic University of Korea Seoul St. Mary’s Hospital, Ajou University Hospital, Severance Hospital, Chung-Ang University Hospital, and Hallym University Kangnam Sacred Heart Hospital.

In the global trials, the company is checking the drug’s efficacy in patients with moderate to severe atopic dermatitis, as well as its treatment effect on eczema in patients with moderate to severe atopic dermatitis.

Baricitinib received the local sales approval on Dec. 11 as an oral treatment for rheumatoid arthritis.

The drug treats moderate to severe rheumatoid arthritis in adults who either do not respond to disease-modifying antirheumatic drugs (DMARDs) or do not have tolerability to DMARDs.

Pfizer Korea’s Xeljanz, launched in 2015 in Korea, is in the same class as baricitinib.

Sold as Olumiant in Europe, baricitinib showed better efficacy than existing rheumatoid arthritis treatments Humira (ingredient: adalimumab) and Methotrexate (MTX) in four clinical trials on more than 3,000 patients including 500 from Asia with rheumatoid arthritis.

The drug’s efficacy was also observed in a variety of patients, including those without MTX treatment experience, those who did not respond well to MTX, those who did not respond sufficiently to at least one existing antirheumatic drug, and those who did not show adequate response to at least one TNF (tumor necrosis factor) inhibitor.

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