Janssen Korea has obtained approval for clinical trials on plaque psoriasis treatment Tremfya (ingredient: guselkumab) to assess the drug’s efficacy for Crohn’s disease.

The Ministry of Food and Drug Safety said it gave the green light to Janssen’s plan for phase-2 and phase-3 trials on guselkumab submitted on Aug. 9.

The local trials will evaluate the efficacy and safety of guselkumab in 68 patients with moderate to severely active Crohn’s disease. The global tests will include more than 2,000 patients around the world, the ministry said.

In Korea, the trials will take place at Kyungpook National University Hospital, Kyunghee University Hospital, CHA Bundang Medical Center, Dong-a University Hospital, Samsung Medical Center, Severance Hospital, Kangbuk Samsung Hospital, Ewha Womans University Medical Center, Chung-Ang University Hospital, Catholic University of Korea St. Vincent's Hospital, Korea University Ansan Hospital, and Inje University Haeundae Paik Hospital.

Tremfya won its sales license in April as a psoriasis treatment. Its efficacy has been recognized in plaque psoriasis, and moderate to severe adulthood plaque psoriasis requiring phototherapy or systemic therapy.

The treatment is a long-term drug that is administered once, four weeks after the first dose, and every eight weeks after that.

According to studies VOYAGE1 and VOYAGE2 that involved 2,000 patients with moderate to severe plaque psoriasis, seven out of 10 patients treated with Tremfya achieved PASI (Psoriasis Area and Severity Index) 90 at 16th week.

PASI scores show the severity of psoriasis based on the extent of psoriasis, erythema thickness, and lesions. PASI90 means symptoms have improved by 90 percent and the patient has almost recovered to clean skin. In the studies, nine out of 10 patients who achieved PASI 90 at 28th week still had the therapeutic effect at 48th week.

Tremfya received sales approval in the U.S. and Europe last year, and in Japan in March.

In Korea, the Health Insurance Review and Assessment Service’s drug reimbursement evaluation committee decided in July that Tremfya could benefit from insurance coverage.