Johnson & Johnson Announced Topline Results From ICONIC-LEAD, A Pivotal Phase 3 Investigational Study Of Icotrokinra, 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; Met Its Co-Primary Endpoints In Patients With Moderate To Severe Plaque Psoriasis; 74% Of Patients Achieved Clear Or Almost Clear Skin At Week 24

Icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, met its co-primary endpoints in patients with moderate to severe plaque psoriasis

74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24

Comprehensive results are being prepared for presentation at upcoming medical congresses

SPRING HOUSE, Pa., Nov. 18, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced positive topline results from ICONIC-LEADa, a pivotal Phase 3 investigational study of icotrokinra (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 (PsO). The Phase 3 study met its co-primary endpoints of Psoriasis Area and Severity Index (PASI) 90b and Investigator's Global Assessment (IGA) of 0/1c response at week 16 and response rates continued to improve through week 24.1

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 (64.7%) of patients treated with icotrokinra achieved IGA scores of 0/1 (clear or almost clear skin), and 49.6% achieved PASI 90, compared to 8.3% and 4.4% on placebo, respectively.1 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 (AEs) between icotrokinra and placebo, with 49.3% and 49.1% of participants experiencing a treatment emergent adverse event (TEAE) at week 16.1,2,3

Furthermore, positive topline results from the Phase 3 ICONIC-TOTALd study showed once daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo.4 Comprehensive results from ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at upcoming medical congresses and will be shared with health authorities in planned submissions.