Johnson & Johnson announces results from ICONIC-LEADa Phase 3 study

Johnson & Johnson announced positive topline results from ICONIC-LEADa, a pivotal Phase 3 investigational study of icotrokinra, or JNJ-2113, the first targeted oral peptide that selectively blocks the IL-23 receptor, in adults and adolescents 12 years of age and older with moderate to severe plaque psoriasis, or PsO. The Phase 3 study met its co-primary endpoints of Psoriasis Area and Severity Index, or PASI, 90b and Investigator’s Global Assessment, or IGA, of 0/1c response at week 16 and response rates continued to improve through week 24. Once daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. At week 16, nearly two-thirds of patients treated with icotrokinra achieved IGA scores of 0/1, and 49.6% achieved PASI 90, compared to 8.3% and 4.4% on placebo, respectively. Further increases in response rates continued to be observed at week 24, with 74.1% of patients treated with icotrokinra achieving IGA scores of 0/1, and 64.9% achieving PASI 90.1 Safety data was found to be consistent with the Phase 2 FRONTIER 1 and 2 studies. A similar proportion of patients experienced adverse events between icotrokinra and placebo, with 49.3% and 49.1% of participants experiencing a treatment emergent adverse event at week 16.