Pfizer Reports Positive Top-Line Results From XELJANZ Phase 3 Maintenance Trial

(RTTNews) - Pfizer Inc. (PFE) announced top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis Sustain, the third Phase 3 study of XELJANZ (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis. The company said top-line results from the OCTAVE Sustain study showed that the proportion of patients in remission at week 52, the primary efficacy endpoint, was significantly greater in both the tofacitinib 5 and 10 mg BID groups compared to placebo.

The OCTAVE global clinical development program includes three Phase 3 studies, OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain, as well as a long-term extension trial, OCTAVE Open. Pfizer expects these four studies will form the submission package to regulatory authorities for a potential ulcerative colitis indication.