Title: Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn’s disease: a randomized, double-blind, placebo-controlled phase 2 study

Feagan, BG et al.


What You Need to Know:

Risankizumab (BI 655066) more effectively induced clinical remission in patients with active Crohn’s disease compared to placebo, suggesting that selective blockade of interluekin-23 via p19 inhibition may be a potential therapeutic target in Crohn’s disease.

Trial Design:

  • Phase 2, randomized, double-blind, placebo-controlled study across North America, Europe, and southeast Asia
  • Patients aged 18-75 years with moderate-to-severe Crohn’s disease for ≥3 months (CDAI 220-450 with mucosal ulcers in ileum and/or colon, and CDEIS ≥7 [≥4 if isolated ileitis])
  • 121 patients randomized 1:1:1 to risankizumab 200mg, risankizumab 600mg, or placebo at Weeks 0, 4, 8
  • Primary outcome: clinical remission (CDAI <150) at Week 12 (intent-to-treat population)

Key Outcomes:

  • At baseline, 93% of patients were previously treated with ≥1 TNF antagonist (failed in 79%)
  • At Week 12, 31% of risankizumab patients had clinical remission vs. 15% of placebo patients (difference from placebo 15.0%, 95% CI: 0.1-30.1; P=0.0489)
  • 24% of patients in the risankziumab 200mg group (difference 9.0%, 95% CI: -8.3 to 26.2; P=0.31) and 37%  of patients in the risankizumab 600mg group (difference 20.9% , 95% CI: 2.6-39.2; P=0.252) had clinical remission
  • Adverse events occurred in 95 (79%) patients: 32 in the 200mg group, 31 in the 600mg group, and 32 in placebo
  • Most common adverse event was nausea; most serious adverse event was worsening of Crohn’s disease