This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
136
oral; tablet
oral; tablet
Change from baseline in the urticaria activity score (UAS7)
Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity.
Time frame: 12 Weeks
Proportion of participants who achieve UAS7 ≤ 6 (controlled disease) at Week 12
Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity.
Time frame: 12 Weeks
Time to first achievement of UAS7 ≤ 6 (controlled disease) during the PC period
Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS. UAS scores range from 0-42; with higher scores reflecting greater disease activity.
Time frame: 12 Weeks
Proportion of participants with UAS7 = 0 at Week 12.
Defined as the 7-day sum of the individual, daily recorded scores for HSS and ISS, at week 12. UAS scores range from 0-42; with higher scores reflecting greater disease activity.
Time frame: 12 Weeks
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