Abbvie’s new drug Risankizumab, being developed to treat the Crohn’s disease, received a government approval for phase three clinical trials in three areas in Korea.
The Ministry of Food and Drug Safety (MFDS)식품의약품안전처 Tuesday approved the plan for phase three clinical trials that Abbvie Korea applied for.
Risankizumab is the IL(interleukin)-23 inhibitor therapy that Abbvie에브비 and Boehringer Ingelheim베링거인겔하임 jointly developed for the Crohn’s disease, psoriasis, joint inflammation and asthma. Abbvie is in charge of the global sales.
The three approved clinical trials are related to the Crohn’s disease, an inflammatory intestinal disease that affects any part from the end of the small intestine to the large intestine.
One clinical trial will evaluate safety and effectiveness of induction therapy on 30 serious Crohn’s patients whose biological treatments failed in the past. Another will assess the treatment’s effectiveness and safety for another 40 serious Crohn’s patients. The two trials are multi organs, random assignment, double blind and placebo contrast clinical trials.
And they will evaluate safety and effectiveness of the drug on 20 Crohn’s patients whose guided treatments were effective in M16-006 or M15-991 clinical trials. These are 52-week long trials and multi organs, random assignment, double blind, and placebo contrast trials.
Meanwhile, the U.S Food and Drug Administration(FDA) designated Risankizumab as an orphan drug to cure the pediatric Crohn’s disease in December 2016.
Risankizumab is being developed as a psoriasis therapy. According to an interim report of the extended research of phase two trial released in 2016, patients with serious and chronic psoriasis who changed the drug from a IL therapy Stelara (compound: ustekinumab) to Risankizumab(90mg) or got treatment again with Risankizumab(90mg) maintained skin improvement or achieved PASI 90 (90 percent decrease in PASI score against baseline).