Include more govt sites: CDSCO Panel to Parexel on Clinical Trial of Guselkumab

Guselkumab is a fully human IgG1 lambda monoclonal antibody that selectively inhibits the p19 subunit of IL-23. The binding of guselkumab to IL-23 blocks interaction between extracellular IL-23 to the cell surface IL-23R receptor, inhibiting IL-23–specific intracellular signaling and subsequent activation of cytokine production.

Guselkumab is currently approved for and has demonstrated efficacy and safety in the short- and long-term treatment of other inflammatory diseases, including moderate-to-severe plaque psoriasis and active psoriatic arthritis.

The aim of GALAXI study is to evaluate the efficacy and safety of guselkumab in patients with moderately to severely active Crohn's disease with inadequate response or intolerance to conventional or biologic therapy.

Crohn's disease is a type of inflammatory bowel disease (IBD). It causes inflammation of your digestive tract, which can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition.

GALAXI-1 is an ongoing phase 2, randomized, double-blind, placebo- and active-controlled, multicenter study with participants randomized at 128 sites in 32 countries. The primary objective of the study was to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease who had an inadequate response or intolerance to conventional therapy or biologic therapy.

The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.

At recent SEC meeting for gastroenterology and hepatology, the global clinical research organization Parexel presented the proposal to conduct Phase II/III clinical trial (GALAXI study) protocol no: CNTO1959CRD3001, amendment 4 dated 21-JUL-2021 before the committee.

In addition, the firm also mentioned that India will be participating in the Phase III part (i.e. GALAXI 2 and GALAXI 3) of the trial.

After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial with condition that the firm should include more number of Govt. sites to have the sites geographically distributed in the country.