Policy & Regulation
Janssen Pharmaceutical's Stelara single dose succeeds in phase three ulcerative colitis study
11 October 2018 -

Johnson & Johnson's subsidiary, Janssen Pharmaceutical Companies' single dose of Stelara has induced clinical remission and response in adults with moderate to severe ulcerative colitis, it was reported yesterday.

The trial indicated that Stelara induced clinical remission in a significantly greater proportion of UC patients at week eight compared to placebo at both doses studied. Major secondary endpoints such as the proportion of patients in clinical response, endoscopic healing and improvement in health-related quality of life were also higher at week eight among patients securing Stelara compared to patients receiving placebo.

The Unifi phase three study was designed to evaluate the safety and efficacy of Stelara induction and maintenance dosing to treat moderate to severe ulcerative colitis in adults who showed an inadequate response to or were unable to tolerate conventional or biologic therapies. The eight-week duration is compulsory for each participant in the induction study. Participants achieving clinical response in the induction study are eligible for the maintenance study, which is 44 weeks duration. The primary endpoint of the induction study is clinical remission at week 8, while the primary endpoint for the maintenance study is clinical remission at week 44 among responders to a single IV Stelara infusion.

It is also approved to treat adult patients 18 years or older with active psoriatic arthritis, as well as moderately to severely active Crohn's disease who have failed or were intolerant to immunomodulators or corticosteroids.



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