AbbVie said it would conduct a phase-3 clinical trial on upadacitinib, a treatment for rheumatoid arthritis, to evaluate its efficacy in ulcerative colitis in Korea.
The Ministry of Food and Drug Safety on Thursday approved AbbVie Korea’s plan for the phase-3 study on ABT494 (upadacitinib). The trial will take place in multiple institutions including CHA Bundang Medical Center, Dong-A University Hospital, Samsung Medical Centerm, Asan Medical Center, and Severance Hospital, to evaluate the drug’s safety and efficacy in 70 domestic patients.
Upadacitinib is an autoimmune disease drug that blocks Janus Kinases 1 (JAK1), an enzyme that causes inflammation. AbbVie expects the agent to become a follow-up drug after Humira. The company is having trials on upadacitinib for other indications such as ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and severe Crohn's disease.
In Korea, the company obtained approval for all the phase-3 studies involving upadacitinib.
According to the global phase-2b trial, U-ACHIEVE in patients with moderately to severely active ulcerative colitis, the eight-week treatment with a once-daily dosage of upadacitinib showed superiority to reach higher clinical remission, compared to the placebo.
The placebo group had zero clinical remission, but the upadacitinib group had 14 percent clinical remission in 15mg dosage, 14 percent in 30mg, and 20 percent in 45mg.