A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study of Barzolvolimab in Participants with Cold Induced Urticaria and Symptomatic Dermographism (EMBARQ-COLDU and SD)

Cold-Induced Urticaria and Symptomatic Dermographism

• ColdU: Proportion of participants with complete response in Critical Temperature Threshold (CTT) following the TempTest® 4.0 at Week 12 • SD: Proportion of participants with complete response in Critical Friction Threshold (CFT) following the FricTest® 4.0 at Week 12

• ColdU: Change from baseline in CTT following the TempTest® at Week 12 • SD: Change from baseline in CFT following the FricTest® at Week 12, • ColdU: Proportion of participants with complete response in CTT following the TempTest® at Week 24 • SD: Proportion of participants with complete response in CFT following FricTest® at Week 24, • ColdU: Change from baseline in CTT following the TempTest® at Week 24 • SD: Change from baseline in CFT following the FricTest® at Week 24", • ColdU: Change from baseline in worst itch-numeric rating scale (WI-NRS) at Week 12 • SD: Change from baseline in worst itch-numeric rating scale (WI-NRS) at Week 12, • ColdU: Change from baseline in WI-NRS at Week 24 • SD: Change from baseline in WI-NRS at Week 24, • ColdU: Change from baseline in WI-NRSprovo following the TempTest® at Week 12 • SD: Change from baseline in WI-NRSprovo following the FricTest® at Week 12, • ColdU: Proportion of participants with complete response in CTT following the TempTest® at Week 4 • SD: Proportion of participants with complete response in CFT following FricTest® at Week 4, • ColdU: Change from baseline in CTT following the TempTest® at Week 4 • SD: Change from baseline in CFT following the FricTest® at Week 4, • ColdU: Change from baseline in worst hives-numeric rating scale (WH-NRS) at Week 12 • SD: Change from baseline in WH-NRS at Week 12, • ColdU: Change from baseline in WH-NRS at Week 24 • SD: Change from baseline in WH-NRS at Week 24, • ColdU: Proportion of participants with DLQI = 0-1 at Week 12 • SD: Proportion of participants with DLQI = 0-1 at Week 12, • Safety endpoints will include but not be limited to: • Incidence of treatment-emergent adverse events • Incidence of treatment-emergent serious adverse events • Incidence of treatment-emergent adverse events of special interest

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