Icotrokinra Results Show 75% of Adolescents with Plaque Psoriasis Achieved Completely Clear Skin and Demonstrate Favorable Safety Profile with a Once Daily Pill

84% of adolescents with moderate-to-severe plaque psoriasis treated with investigational icotrokinra achieved clear or almost clear skin (IGA 0/1) at Week 16

ICONIC-LEAD is the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis to assess safety and efficacy of a systemic therapy in adolescents and adults simultaneously

Excerpt from the Press Release:

NEWARK, CA / ACCESS Newswire / April 10, 2025 / Protagonist Therapeutics, Inc. (“Protagonist” or the “Company”) announced new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEAD^a, the first ever Phase 3 registrational study in moderate-to-severe plaque psoriasis (PsO) to assess efficacy and safety of an orally delivered systemic therapy in adolescents and adults simultaneously.

Data from an oral presentation at the 2025 World Congress of Pediatric Dermatology (WCPD) Annual Meeting show adolescents treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo, with no new safety signals identified.¹ 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.

Key findings from the adolescent cohort of the ICONIC-LEAD study:

• At week 16, 84.1% of adolescent patients treated with once daily icotrokinra achieved an Investigator’s Global Assessment (IGA)^b score of 0/1 (clear or almost clear skin) and 70.5% achieved a Psoriasis Area and Severity Index (PASI)^c 90 response, compared to 27.3% and 13.6% receiving placebo, respectively.¹
• Response rates continued to improve through Week 24 where 86.4% of adolescents achieved IGA 0/1 and 88.6% achieved PASI 90.
• At week 24, 75% of adolescents achieved IGA 0 (completely clear skin) and 63.6% achieved PASI 100.
• Icotrokinra demonstrated a favorable safety profile, with 50% of adolescents treated with icotrokinra experienced ≥1 adverse event (AE), compared to 73% of adolescents receiving placebo at 16 weeks. No new safety signals were identified.¹

“We are thrilled with the data from the Phase 3 ICONIC LEAD subgroup analysis, which suggests icotrokinra may provide a novel first line treatment option for moderate-to-severe plaque psoriasis in adolescents who have not yet received an advanced injectable therapy,” said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist.

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