J&J : Phase 3 Study Of Icotrokinra Shows Significant Skin Clearance & Safety In Plaque Psoriasis

(RTTNews) - Johnson & Johnson (JNJ) announced new icotrokinra (JNJ-2113) data from its Phase 3 clinical program and the start of the first-ever head-to-head study in plaque psoriasis (PsO) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab.

Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.

The company noted that data from the Phase 3 ICONIC-LEAD study showed once daily icotrokinra demonstrated significant skin clearance and a favorable safety profile in adults and adolescents 12 years of age and older with moderate-to-severe plaque plaque psoriasis or PsO.

In the ICONIC-LEAD study, nearly two-thirds (65%) of patients treated with once daily icotrokinra achieved an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) and 50% achieved a Psoriasis Area and Severity Index (PASI) 90 response, compared to 8% and 4% receiving placebo, respectively at Week 16.

According to the company, continued skin clearance improvement was reported at Week 24 with 74% of patients treated with icotrokinra achieving IGA 0/1 and 65% achieving PASI 90. At Week 24, nearly half of patients treated with icotrokinra achieved completely clear skin - 46% reached IGA 0 and 40% reached PASI 100. Similar proportions of patients experienced adverse events (AEs) between icotrokinra (49%) and placebo groups (49%), with no new safety signals identified.

Results from a subgroup analysis of the ICONIC-LEAD study evaluating icotrokinra in the adolescent population will be presented at a forthcoming medical meeting.

In addition, topline results show that the Phase 3 ICONIC-ADVANCE 1&2e studies met their co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.

Based on the positive outcomes of the ADVANCE studies, Johnson & Johnson is initiating the Phase 3 ICONIC-ASCEND study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab representing an important step forward in psoriasis research.

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