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ICONIC-LEAD PHASE3 COMPLETED n=600
Drug: Icotrokinra · JNJ
Study Design
DesignRandomized, double-blind, placebo-controlled
Randomization2:1
BlindingDouble-blind
Enrollment600
Duration52 weeks
Treatment Arms
Icotrokinra 25mg QD 25mg oral once daily n=400
Placebo Matching oral placebo once daily n=200
Primary Endpoints
[{"id":"iga01-w16","name":"IGA 0/1 at Week 16","type":"PRIMARY","unit":"%","results":[{"value":64.7,"arm_id":"ico-arm","p_value":0.001,"vs_placebo":"vs placebo"},{"value":8.3,"arm_id":"pbo-arm"}],"timepoint":"Week 16","description":"Clear or almost clear skin by physician global assessment at 16 weeks."}]
Assessment
LANDMARK: First oral drug to approach injectable biologic-level efficacy in psoriasis. PASI 90 deepens from 50% Wk16 to 65% Wk24 to 84% Wk52. IGA 0/1 65% Wk16 is competitive with injectable biologics. Safety nearly identical to placebo. Published NEJM Nov 2025. NDA filed Jul 2025, PDUFA expected Q2 2026. If approved, will disrupt the entire psoriasis treatment paradigm — biologic efficacy in a pill with placebo-like safety.
Data from Supabase · Updated 2026-03-24