The purpose of this extension study is to collect long-term efficacy and safety data on barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods of the Phase 3 clinical trials. This study will also fulfill the Celldex commitment to provide post-trial access to participants who have completed the phase 3 studies, where applicable.
This is a global, multicenter, long-term extension phase 3b study to determine the time to disease worsening or treatment failure in adult participants with Chronic Spontaneous Urticaria (CSU) who completed the treatment and follow-up periods the phase 3 clinical trials. The study will consist of 2 Groups: Group 1 (Observation Group), comprising participants whose UAS7 score is less than 16 at entry and Group 2 (Barzolvolimab Retreatment Group) comprising participants whose UAS7 score is 16 or greater. Participation in this trial will last for approximately 52 weeks for participants assigned to Group 1 (Observation Group) and who do not receive barzolvolimab during the trial. Participants assigned to Group 1 who require barzolvolimab rescue during the trial will be in the trial for up to 68 weeks. Participants assigned to Group 2 (Barzolvolimab Retreatment Group), trial participation will last for approximately 68 weeks from the start of treatment (Day 1).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,370
Subcutaneous Administration
Observational/Standard of Care
Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.
The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Time frame: From Day 1 (baseline) to Week 52.
Time to disease worsening or treatment failure through Week 52 based on the occurrence of the discontinuation of barzolvolimab in Group 2 due to lack of efficacy or to a treatment related adverse event.
Evaluate duration of efficacy of barzolvolimab on urticaria activity or to a treatment related adverse event.
Time frame: From Day 1 (baseline) to Week 52.
Time to disease worsening or treatment failure through Week 52 based on the occurrence of first use of strongly confounding prohibited medication (Group 1 or 2) or use of barzolvolimab in Group 1.
Evaluate duration of efficacy of barzolvolimab on urticaria activity leading to initiation of either a confounding prohibited medication (Group 1 or 2) or barzolvolimab in Group 1.
Time frame: From Day 1 (baseline) to Week 52.
Group 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 26.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7). The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
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Time frame: From Day 1 (baseline) in phase 3 trial to Week 26.
Group 1: Change from baseline in UAS7 at Week 52/End of Study.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) The UAS7 is a simple scoring system to evaluate urticaria signs and symptoms. It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
Time frame: From Day 1 (baseline) in phase 3 trial to Week 52/End of Study.
Percentage of Group 1 participants with UAS7 ≤ 6 at week 26.
Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 26.
Time frame: From Day 1 (baseline) to Week 26.
Percentage of Group 1 participants with UAS7 ≤ 6 at week 52.
Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 52.
Time frame: From Day 1 (baseline) to Week 52/End of Study.
Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 26.
Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0) at Day 1 who have well controlled CSU (UAS7 ≤ 6) at Week 26.
Time frame: From Day 1 (baseline) to Week 26.
Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 52.
Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0) at Day 1 who have well-controlled disease (UAS7 ≤ 6) at Week 52.
Time frame: From Day 1 (baseline) to Week 52/End of Treatment.
Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 26.
Angioedema Activity Score over 7 days \[AAS7\] describes the effect of angioedema on five categories with 0 being none and 3 being most severe. The final score is calculated by adding together daily scores which can range from 0-15 for 7 days. The resulting maximum score is then 105.
Time frame: From Day 1 (baseline) to Week 26.
Group 1: Proportion of participants with complete absence of hives and itch (UAS7 = 0 AAS7 = 0) at Day 1 who maintained complete control at Week 52.
Angioedema Activity Score over 7 days \[AAS7\] describes the effect of angioedema on five categories with 0 being none and 3 being most severe. The final score is calculated by adding together daily scores which can range from 0-15 for 7 days. The resulting maximum score is then 105.
Time frame: From Day 1 (baseline) to Week 52/End of Study.
Group 1: Participants with UAS7 ≤ 6 at Day 1, time to loss of well-controlled disease through Week 52.
Group 1: Participants with at least well-controlled disease (UAS7 ≤ 6) at Day 1, time to loss of well-controlled disease through Week 52.
Time frame: From Day 1 (baseline) to Week 52/End of Study.
Group 1: Participants with UAS7 = 0 at Day 1, time to loss of complete controlled disease through Week 52.
Group 1: Participants with complete absence of hives and itch (UAS7 = 0) at Day 1, time to loss of complete controlled disease through Week 52.
Time frame: From Day 1 (baseline) to Week 52/End of Study.
Group 1: Participants with UAS7 = 0 and AAS7 = 0 at Day 1, time to loss of CSU completely controlled through Week 52.
Group 1: Participants with complete controlled CSU (UAS7 = 0 and AAS7 = 0) at Day 1, time to loss of CSU completely controlled through Week 52.
Time frame: From Day 1 (baseline) to Week 52/End of Study.
Group 2: Change from baseline in UAS7 at Week 12.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Time frame: From Day 1 (baseline) to Week 12.
Group 2: Change from baseline in UAS7 at Week 24.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Time frame: From Day 1 (baseline) to Week 24.
Group 2: Change from baseline in UAS7 at Week 52.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Time frame: From Day 1 (baseline) to Week 52.
Group 2: Change from baseline in UAS7 at Week 68.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Time frame: From Day 1 (baseline) to Week 68.
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 12.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 12.
Time frame: From Day 1 (baseline) to Week 12.
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 24.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 24.
Time frame: From Day 1 (baseline) to Week 24.
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 52.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 52.
Time frame: From Day 1 (baseline) to Week 52.
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 68.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 68.
Time frame: From Day 1 (baseline) to Week 68.
From Day 1 (baseline) to Week 68.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.
Time frame: From Day 1 (baseline) to Week 12.
Group 2: Percentage of participants with UAS7 = 0 at Week 24.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24.
Time frame: From Day 1 (baseline) to Week 24.
Group 2: Percentage of participants with UAS7 = 0 at Week 52.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 52.
Time frame: From Day 1 (baseline) to Week 52.
Group 2: Percentage of participants with UAS7 = 0 at Week 68.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 68.
Time frame: From Day 1 (baseline) to Week 68.
Group 1 Incidence of adverse events.
Group 1: Proportion of participants experiencing adverse events during the study.
Time frame: From Day 1 to Week 52.
Group 1 Incidence of non-treatment emergent adverse events.
Group 1: Proportion of participants who never receive barzolvolimab retreatment experiencing non-treatment emergent adverse events.
Time frame: From Day 1 to Week 52.
Group 1 Incidence of treatment emergent adverse events in participants receiving barzolvolimab retreatment.
Group 1: Proportion of participants who receive barzolvolimab retreatment experiencing treatment emergent adverse events.
Time frame: From Day 1 to Week 68.
Group 1 Incidence of treatment emergent adverse events leading to treatment discontinuation.
Group 1: Proportion of participants who receive barzolvolimab retreatment experiencing treatment emergent adverse events leading to treatment discontinuation during the study.
Time frame: From Day 1 to Week 68.
Group 2 Incidence of treatment emergent adverse events.
Group 2: Proportion of participants experiencing treatment emergent adverse events during the study.
Time frame: Time Frame: From Day 1 to Week 68.
Group 2 Incidence of treatment emergent adverse events leading to treatment discontinuation.
Group 2: Proportion of participants experiencing treatment emergent adverse events leading to treatment discontinuation during the study.
Time frame: From Day 1 to Week 68.