Janssen Pharmaceutical has reported positive results from the Phase III UNIFI clinical trial of subcutaneous (SC) Stelara (ustekinumab) as a maintenance therapy in adults with moderate to severe ulcerative colitis (UC).
The trial met its primary endpoint, with a significantly greater proportion of patients treated with Stelara achieving clinical remission at one year, compared to placebo.
Janssen noted that patients in the investigational therapy arm were in clinical response eight weeks after treatment with a single intravenous (IV) induction dose.
Stelara is a human IL-12 and IL-23 antagonist. It already has approvals for treating moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn's disease in specific patients.
UNIFI was conducted to assess the safety and efficacy of the drug’s induction and maintenance dosing in moderate to severe UC patients who had an inadequate response to or were unable to tolerate standard or biologic therapies.
Clinical remission at weeks eight and 44 was the primary endpoint for the induction and maintenance study, respectively, among responders to a single IV Stelara infusion.
The drug also achieved significance in key secondary endpoints such as maintenance of clinical response and remission, compared to placebo.
The proportion of subjects with adverse events (AEs), serious AEs, infections and serious infections in the Stelara groups were generally comparable to the placebo arm.
Janssen Research & Development gastroenterology disease area and IL-23 pathway leader Scott Plevy said: “The UNIFI maintenance data further build the case for Stelara as a potential new treatment option for ulcerative colitis and illustrate our ongoing commitment to researching and developing meaningful therapies for people living with inflammatory bowel diseases.”
The company has included the UNIFI results in its submissions seeking approval from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to use the drug for UC treatment.