New Oral Psoriasis Drug Icotrokinra Outperforms Existing Treatment in Phase 3 Trials
Oral peptide targeting IL-23 receptor shows superior efficacy vs placebo and deucravacitinib in moderate-to-severe plaque psoriasis.
Summary
Two phase 3 trials tested icotrokinra, a new oral peptide drug targeting the interleukin-23 receptor, against placebo and deucravacitinib in adults with moderate-to-severe plaque psoriasis. The studies enrolled 1,505 participants across multiple countries. At 16 weeks, 68-70% of icotrokinra patients achieved clear or almost clear skin compared to 9-11% on placebo. Similarly, 55-57% reached 90% improvement in psoriasis severity scores versus 1-4% on placebo. Icotrokinra also showed better results than deucravacitinib with fewer adverse events. The most common side effects were mild respiratory infections. This represents a potential breakthrough as an effective oral alternative to injectable psoriasis treatments.
Detailed Summary
Psoriasis treatment has long relied on injectable biologics targeting inflammatory pathways, but a new oral option may change that landscape. Two large phase 3 trials tested icotrokinra, an oral peptide that selectively binds the interleukin-23 receptor, against both placebo and the existing oral drug deucravacitinib.
The ICONIC-ADVANCE trials enrolled 1,505 adults with moderate-to-severe plaque psoriasis across 13 countries. Participants received once-daily icotrokinra 200mg, placebo, or deucravacitinib 6mg for 16-24 weeks. The primary endpoints measured clear or almost clear skin and 90% improvement in psoriasis severity.
Results were striking: 68-70% of icotrokinra patients achieved clear or almost clear skin at 16 weeks versus only 9-11% on placebo. For the 90% improvement threshold, 55-57% of icotrokinra patients succeeded compared to 1-4% on placebo. Importantly, icotrokinra also outperformed deucravacitinib while causing fewer adverse events (57% vs 65% through 24 weeks).
Safety appeared favorable, with the most common side effects being nasopharyngitis and upper respiratory infections at rates similar to placebo. This suggests icotrokinra could offer psoriasis patients an effective oral alternative to injectable treatments, potentially improving adherence and quality of life. However, longer-term safety data and real-world effectiveness remain to be established.
Key Findings
- 68-70% of patients achieved clear/almost clear skin vs 9-11% on placebo at 16 weeks
- 55-57% reached 90% psoriasis improvement vs 1-4% on placebo
- Outperformed existing oral drug deucravacitinib with fewer side effects
- Most common adverse events were mild respiratory infections
- First oral peptide targeting IL-23 receptor to show phase 3 efficacy
Methodology
Two randomized, double-blind, placebo-controlled phase 3 trials enrolled 1,505 adults with moderate-to-severe plaque psoriasis across 149-114 sites in 11-13 countries. Participants were randomized to icotrokinra 200mg daily, placebo, or deucravacitinib 6mg daily.
Study Limitations
Summary based on abstract only. Long-term safety and durability data beyond 24 weeks not available. Real-world effectiveness and comparative cost-effectiveness versus established biologics remain unknown. Johnson & Johnson funding may introduce bias.
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