AbbVie Announces Positive Topline Results from Phase 3 Affirm Study Evaluating SKYRIZI®? (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease
AbbVie announced positive topline results from the Phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (SKYRIZI®?) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD). The AFFIRM study results show significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remissiona (55% vs. 30%; p. The study consists of three treatment periods: a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients receive blinded or open-label treatments based on their clinical response at week 12, and a 52-week open-label extension Period C where all patients receive the approved risankizumab maintenance treatment.
AbbVie Inc. specializes in therapeutic drug research and development. Its products are intended for treating rheumatoid arthritis, psoriasis, Crohn's disease, thyroid disease, Parkinson's disease, HIV, complications of mucoviscidosis, low testosterone levels, and complications associated with chronic renal disease.
Net sales are distributed geographically as follows: the United States (76.2%), Germany (2.8%), Japan (2.1%), Canada (2%), China (1.6%), France (1.3%), the United Kingdom (1%), Spain (1%), Italy (0.9%), Brazil (0.8%), Australia (0.8%), and Other (9.5%).
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AbbVie Announces Positive Topline Results from Phase 3 Affirm Study Evaluating SKYRIZI®? (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease