Janssen Pharmaceutical has reported positive eight-week induction data from Phase III Unifi clinical trial of Stelara (ustekinumab) for the treatment of adults with moderate to severe ulcerative colitis (UC).
Results demonstrated that a single intravenous (IV) dose of the investigational drug led to clinical remission and response, compared to placebo, in patients with prior inadequate response or intolerance to standard or biologic therapies.
In addition, certain secondary endpoints such as the proportion of patients in clinical response and endoscopic healing were significantly higher at week 8 in participants treated with Stelara.
Stelara is a human IL-12 and IL-23 antagonist approved in the US for the treatment of adults with moderately to severely active Crohn’s disease or active psoriatic arthritis.
It is also approved for moderate to severe plaque psoriasis in adults and children aged 12 years and older.
The Phase III UNIFI trial is assessing the safety and efficacy of Stelara induction and maintenance dosing in moderate to severe ulcerative colitis patients.
Primary endpoint of the induction study is clinical remission at week 8. Patients achieving the clinical response were eligible for the 44-week maintenance study.
The primary endpoint for the maintenance study is clinical remission at week 44 to a single IV Stelara infusion.
Janssen Research & Development Clinical Development vice-president Philippe Szapary said: “Stelara is the first biologic approved for any indication that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, like ulcerative colitis.
“This induction data from the Phase 3 UNIFI study underscore the potential for this pathway in the treatment of UC, which may lead to a new effective and safe treatment option for UC patients in the future.”
Janssen presented the UNIFI induction data at the American College of Gastroenterology (ACG) Scientific Meeting 2018.
Also, the company presented results from the IM-UNITI open label long-term extension (LTE) study of Stelara for the treatment of adults with moderate to severe Crohn’s disease.