Shots:
- The P-II trial assessed barzolvolimab (Q4W: 75 or 150mg; Q8W: 300mg) vs PBO for 16wks. in 208 CSU pts unresponsive to antihistamines, followed by 36wks. of active treatment, where 75mg & PBO pts were re-randomized to 150 or 300mg; pts were then followed for 24wks. Enrolment to P-III (EMBARQ-CSU1 & EMBARQ-CSU2) trials is ongoing
- Trial met its 1EP of significant mean UAS7 reduction at Wk. 12 across all doses, with rapid improvements by Wk. 1, sustained or deepened through Wk. 76 (mean change: -20.42 for 150mg; -21.10 for 300mg); 41% (150mg) & 35% pts (300mg) achieved CR (UAS7=0) at Wk. 76
- At Wk. 76, 56% (150mg) & 47% (300mg) had well-controlled disease (UAS7≤6), with 48% & 40% reporting no QoL impact (DLQI=0/1), regardless of prior Xolair use
Ref: GlobeNewswire | Image: Celldex| Press Release
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