Landscape（CSU ／CIndU ）
〜Novartis vs Celldex（CLDX）〜
KEY WORD：CLDX・①CSU ・mast cell・DMT・2026-10・Phase3
◆Novartis
1. Xolair®（omalizumab）
①CSU（marketed product）
MoA：A humanized anti-IgE"monoclonal antibody" that binds circulating IgE, reducing FcεRI expression and"lowering mast cell activation" in"IgE-dependent" disease.
2. Remibrutinib (LOU064：Rhapsido™）
MoA：A highly selective,"oral" BTK inhibitor that blocks FcεRI-mediated signaling pathways,"suppressing mast cell and basophil degranulation".
①CSU
FDA approved（"2025-09"）
❷CIndU
Phase3（NCT05976243）
・Primary Completion＊2026-03-30
・Study Completion＊2028-08-01
・Enrollment 364
◆CLDX
barzolvolimab（CDX‑0159）
MoA：selective KIT inhibitor"monoclonal antibody" that disrupts SCF/KIT survival signaling, inducing"mast cell depletion in tissue".
①CSU
Phase 3（NCT06455202）
・Primary Completion＊"2026-10"
→enrolled by summer 2026（PR）
・Study Completion＊2027-04
・Enrollment＊915
❷ CIndU（ColdU／SD）
Phase 3（NCT07266402）
・Primary Completion＊2028-06
・Study Completion＊2028-10
・Enrollment＊240
◆My view (CLDX＞Novartis）
・Novartis：Remibrutinib（Rhapsido™）
“Functional suppression of mast cell activation”— requires ongoing dosing.
・CLDX：barzolvolimab（CDX‑0159）
“Mast cell depletion”— potential durability and a theoretical"DMT" profile, pending long‑term safety confirmation.
Supplement
Other study（CDX‑0159）
Phase 2：NCT06366750
PN may provide"supportive high‑dose safety signals", but CSU/CIndU still requires dedicated long‑term safety confirmation.
• Primary Completion："2026‑06"
• Enrollment：140
＊Estimated
abbreviations
CSU：Chronic Spontaneous Urticaria
CIndU：Chronic Inducible Urticaria
ColdU：cold induced urticaria
SD：symptomatic Dermographism
SCF：Stem Cell Factor
"DMT"：Disease Modifying Therapy
PN：Prurigo Nodularis
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