A Phase 3b Long-term Efficacy and Safety Extension Study of Barzolvolimab in Participants with Chronic Spontaneous Urticaria Who Have Completed CDX0159-12 or CDX0159-13 (EMBARQ-CSU LTE)

Chronic Spontaneous Urticaria

Time to disease worsening or treatment failure through Week 52 based on the first of the following events: 1. Urticaria Activity Score over 7 days (UAS7) ≥ 16*, 2. Discontinuation of barzolvolimab in Group 2 (Barzolvolimab Retreatment Group) due to lack of efficacy or to a treatment related adverse event (AE), 3. First use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1

1. In participants in Group 1 (Observation Group): Change from baseline (CDX0159-12 or CDX0159-13) in UAS7 at Week 26; at EOS, 2. In participants in Group 1 (Observation Group) with at least well-controlled disease (UAS7 ≤ 6) at baseline of Long-term Extension (LTE): Percentage of participants with at least well-controlled disease at Week 26; at EOS, 3. In participants in Group 1 (Observation Group) with complete control (UAS7 = 0) at baseline of LTE: Percentage of participants with at least well-controlled disease at Week 26; at EOS, 4. In participants in Group 1 (Observation Group) with chronic spontaneous urticaria (CSU) completely controlled (UAS7 = 0 and Angioedema Activity Score over 7 days [AAS7] = 0) at baseline of LTE: Percentage of participants with CSU completely controlled at Week 26; at EOS, 5. In participants in Group 1 (Observation Group) with at least well-controlled disease (UAS7 ≤ 6) at baseline of LTE: Time to loss of well-controlled disease through EOS, 6. In participants in Group 1 (Observation Group) with complete control of disease (UAS7 = 0) at baseline of LTE: Time to loss of complete control through EOS, 7. In participants in Group 1 (Observation Group) with CSU completely controlled (UAS7 = 0 and AAS7 = 0) at baseline of LTE: Time to loss of CSU completely controlled through EOS, 8i. In participants in Group 2 (Barzolvolimab Retreatment Group): • Change from LTE baseline UAS7 at Week 12; at Week 24; at Week 52; at EOS, 8ii. Percentage of participants with UAS7 ≤ 6 at Week 12; at Week 24; at Week 52; at EOS, 9i. In participants in Group 1 (Observation Group): Percentage of participants experiencing AEs from baseline through EOS, 9ii. In participants in Group 1 (Observation Group): Percentage of participants experiencing serious AEs from baseline through EOS, 9iii. In participants in Group 1 (Observation Group) who never receive barzolvolimab retreatment during the LTE: Percentage of participants experiencing non-treatment emergent AEs from baseline through EOS, 10i. In participants in Group 1 (Observation Group) who never receive barzolvolimab retreatment during the LTE: Percentage of participants experiencing non-treatment emergent serious AEs from baseline through EOS, 10ii. In participants in Group 1 (Observation Group) who receive barzolvolimab retreatment during the LTE: Percentage of participants experiencing treatment emergent adverse events (TEAEs) from baseline through EOS, 11i. In participants in Group 1 (Observation Group) who receive barzolvolimab retreatment during the LTE: Percentage of participants experiencing treatment emergent serious AEs from baseline through EOS, 11ii. In participants in Group 1 (Observation Group) who receive barzolvolimab retreatment during the LTE: Percentage of participants experiencing TEAEs leading to treatment discontinuation from baseline through EOS, 12. In participants in Group 2 (Barzolvolimab Retreatment Group): • Percentage of participants experiencing TEAEs from baseline through EOS • Percentage of participants experiencing treatment-emergent serious AEs from baseline through EOS • Percentage of participants experiencing TEAEs leading to treatment discontinuation from baseline through EOS

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