AJM300 (carotegrast methyl), an oral alpha4-integrin antagonist, for patients with moderate ulcerative colitis: a phase 3 trial

The Lancet: Gastroenterology & HepatologyScott Cunningham MD PhD, et al. | April 26, 2022



The long-term management of UC is often complicated by an inadequate response to mesalazine and treatment failure with TNFis.   Effective and safe oral immune cell trafficking inhibitors, such as AJM300, are accepted and well-tolerated by patients and have low immunogenicity.

This phase 3 trial was conducted at 82 hospitals and clinics in Japan.  Two hundred three patients with a Mayo Clinic score of 6-10, an endoscopic score > 2, a rectal bleeding subscore > 1, and an inadequate or lack of response to mesalazine were enrolled and received AJM300 or placebo for 8 weeks. 

A clinical response occurred by week 8 in 46% and 21% of the patients who received AJM300 and placebo, respectively.  The incidence of adverse events, the most frequent of which was nasopharyngitis, was similar in both groups of patients and considered mild-to-moderate in severity.