On June 20th, Johnson & Johnson (JNJ.US) announced that the Phase III GRAVITI study of Guselkumab subcutaneous injection (SC) induction therapy for moderate to severe active Crohn's disease (CD) in adults has achieved positive results.
According to Zhitong Finance and Economics App, on June 20th, Johnson & Johnson (JNJ.US) announced that the Phase III GRAVITI study of Guselkumab subcutaneous injection (SC) induction therapy for moderate to severe active Crohn's disease (CD) in adults, with the positive results of this study and two head-to-head Phase III studies (GALAXI 2 and GALAXI 3), Johnson & Johnson has submitted the marketing application for Guselkumab to the FDA for treating CD.
According to the data, GRAVITI study is a randomized, double-blind, placebo-controlled clinical trial that evaluated the efficacy and safety of Guselkumab (SC) induction therapy for moderate and severe active CD patients with inadequate response or intolerance to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics (TNF antagonists or vedolizumab). The primary endpoints of the study were the proportion of patients achieving clinical remission at week 12 and the proportion of patients achieving endoscopic response.
The results showed that at the 12th week of treatment, the clinical remission rate and endoscopic response rate of patients in the Guselkumab (SC) group were significantly higher than those in the placebo group.
In April of this year, head-to-head Phase III studies (GALAXI 2 and GALAXI 3) comparing Guselkumab SC formulation with Ustekinumab achieved superiority endpoints.