Risankizumab is marketed as SKYRIZI, an interleukin-23 antagonist used across plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults. It is a humanized IgG1 monoclonal antibody that selectively binds the p19 subunit of IL-23 and inhibits downstream pro-inflammatory signaling. U.S. initial approval was in 2019.
Risankizumab data in Crohn’s disease showed 55% clinical remission at week 12 in AFFIRM, durable efficacy through 148 weeks in SEQUENCE, and the lowest 24-month switch rate in a U.S. claims analysis.
The FDA has approved icotrokinra, the first oral IL-23 therapy for moderate-to-severe plaque psoriasis. Meanwhile, real-world research shows IL-23 inhibitors produce site-specific responses in high-impact areas like scalp and nails, and combination therapy with ixekizumab and tirzepatide shows superior results for psoriasis patients with obesity.
AbbVie has received a "Moderate Buy" consensus rating from analysts with an average price target of $253.15. The company reported strong quarterly earnings of $2.71 EPS and $16.62 billion revenue, beating estimates. Recent clinical progress includes positive Phase 1 results for an obesity drug candidate showing 7.8-9.8% weight loss.
AbbVie reported Q4 earnings that beat consensus estimates with $16.62 billion in revenue, while facing competitive setbacks in psoriatic arthritis and Medicare pricing challenges for Botox.
AbbVie announced positive topline results from the Phase 3 AFFIRM study showing risankizumab subcutaneous induction achieved superior clinical remission and endoscopic response rates versus placebo in adults with moderately to severely active Crohn's disease.
Eli Lilly's Omvoh demonstrated durable efficacy in Crohn's disease, with over 90% of patients maintaining steroid-free clinical remission through three years of monthly treatment in the Phase III VIVID-2 extension study.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07499232 |
A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease |
RECRUITING | PHASE3 |
| NCT07466550 |
A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants |
NOT_YET_RECRUITING | PHASE1 |
| NCT07352566 |
Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
NOT_YET_RECRUITING | PHASE4 |
| NCT07177118 |
Risankizumab for Fibrostenotic Crohn's Disease Treatment |
NOT_YET_RECRUITING | PHASE3 |
| NCT07138898 |
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
NOT_YET_RECRUITING | PHASE2 |
| NCT07071519 |
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis |
RECRUITING | PHASE3 |
| NCT07007091 |
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants |
COMPLETED | PHASE1 |
| NCT06946524 |
A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants |
COMPLETED | PHASE1 |
| NCT06937619 |
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants |
COMPLETED | PHASE1 |
| NCT06880744 |
A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab |
RECRUITING | PHASE3 |
