Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
- Summary
- 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.
- Short title
- Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Enrolling by invitation
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2028-09-01
- First posted
- 2025-12-01
- Registry last updated
- 2026-08-27
- Primary completion date
- 2028-09-01
- Start date
- 2025-11-25
- Participants
- 1,370
- Participant count basis
- Estimated
- Planned participants
- 1,370
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Celldex Therapeutics
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07256392
- ClinicalTrials.gov ID
- NCT07256392
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Time to disease worsening or treatment failure through Week 52 based on the occurrence of UAS7 (Urticaria Activity Score) of 16 or greater.
Timeframe: From Day 1 (baseline) to Week 52.
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 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.
Timeframe: From Day 1 (baseline) to Week 52.
Evaluate duration of efficacy of barzolvolimab on urticaria activity or to a treatment related adverse event.
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.
Timeframe: From Day 1 (baseline) to Week 52.
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.
Group 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 26.
Timeframe: From Day 1 (baseline) in phase 3 trial to 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.
Group 1: Change from baseline in UAS7 at Week 52/End of Study.
Timeframe: From Day 1 (baseline) in phase 3 trial to 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.
Percentage of Group 1 participants with UAS7 ≤ 6 at week 26.
Timeframe: From Day 1 (baseline) to Week 26.
Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 26.
Percentage of Group 1 participants with UAS7 ≤ 6 at week 52.
Timeframe: From Day 1 (baseline) to Week 52/End of Study.
Group 1: Proportion of participants who maintained at least well-controlled disease (UAS7 ≤ 6) at Week 52.
Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 26.
Timeframe: From Day 1 (baseline) to 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.
Percentage of Group 1 participants with UAS7 = 0 at Day 1 who have UAS7 ≤ 6 at Week 52.
Timeframe: From Day 1 (baseline) to Week 52/End of Treatment.
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.
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.
Timeframe: From Day 1 (baseline) to 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.
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.
Timeframe: From Day 1 (baseline) to Week 52/End of Study.
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.
Group 1: Participants with UAS7 ≤ 6 at Day 1, time to loss of well-controlled disease through Week 52.
Timeframe: From Day 1 (baseline) to Week 52/End of Study.
Group 1: Participants with at least well-controlled disease (UAS7 ≤ 6) at Day 1, time to loss of well-controlled disease through Week 52.
Group 1: Participants with UAS7 = 0 at Day 1, time to loss of complete controlled disease through Week 52.
Timeframe: From Day 1 (baseline) to Week 52/End of Study.
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.
Group 1: Participants with UAS7 = 0 and AAS7 = 0 at Day 1, time to loss of CSU completely controlled through Week 52.
Timeframe: From Day 1 (baseline) to Week 52/End of Study.
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.
Group 2: Change from baseline in UAS7 at Week 12.
Timeframe: From Day 1 (baseline) to Week 12.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Group 2: Change from baseline in UAS7 at Week 24.
Timeframe: From Day 1 (baseline) to Week 24.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Group 2: Change from baseline in UAS7 at Week 52.
Timeframe: From Day 1 (baseline) to Week 52.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Group 2: Change from baseline in UAS7 at Week 68.
Timeframe: From Day 1 (baseline) to Week 68.
Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS7).
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 12.
Timeframe: From Day 1 (baseline) to Week 12.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 12.
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 24.
Timeframe: From Day 1 (baseline) to Week 24.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 24.
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 52.
Timeframe: From Day 1 (baseline) to Week 52.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 52.
Group 2: Percentage of participants with UAS7 ≤ 6 at Week 68.
Timeframe: From Day 1 (baseline) to Week 68.
Group 2: Proportion of participants with at least well-controlled disease (UAS7 ≤ 6) at Week 68.
From Day 1 (baseline) to Week 68.
Timeframe: From Day 1 (baseline) to Week 12.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.
Group 2: Percentage of participants with UAS7 = 0 at Week 24.
Timeframe: From Day 1 (baseline) to Week 24.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24.
Group 2: Percentage of participants with UAS7 = 0 at Week 52.
Timeframe: From Day 1 (baseline) to Week 52.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 52.
Group 2: Percentage of participants with UAS7 = 0 at Week 68.
Timeframe: From Day 1 (baseline) to Week 68.
Group 2: Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 68.
Group 1 Incidence of adverse events.
Timeframe: From Day 1 to Week 52.
Group 1: Proportion of participants experiencing adverse events during the study.
Group 1 Incidence of non-treatment emergent adverse events.
Timeframe: From Day 1 to Week 52.
Group 1: Proportion of participants who never receive barzolvolimab retreatment experiencing non-treatment emergent adverse events.
And 4 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
- Written informed consent
- Must have successfully completed the preceding phase 3 clinical trials (CDX0159-12 or CDX0159-13).
- Both males and females of child-bearing potential must agree to use highly effective contraceptives when receiving barzolvolimab treatment and for 150 days after treatment.
- Willing and able to comply with all study requirements and procedures, including completion of a daily symptom electronic diary.
Key Exclusion Criteria:
- Active pruritic skin condition in addition to CSU.
- Medical condition that would cause additional risk or interfere with study procedures.
- Participants without at least one documented UAS7 score from Weeks 64-68 of the CDX0159-12 or CDX0159-13 trials.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
- Cahaba Dermatology & Skin Health Center, LLCBirmingham, United States
- Medical Research of ArizonaScottsdale, United States
- Center for Dermatology & Plastic Surgery - AvacareScottsdale, United States
- Kern ResearchBakersfield, United States
- Allergy and Asthma Associates of Southern California - Laguna Niguel - CRNLaguna Niguel, United States
- Dermatology Research AssociatesLos Angeles, United States
- LA Universal Research Center, Inc.Los Angeles, United States
- Asthma and Allergy AssociatesColorado Springs, United States
- Encore Medical Research of Boynton Beach LLCBoynton Beach, United States
- Dolphin Medical ResearchDoral, United States
- Direct Helpers Research CenterHialeah, United States
- Miami Dade Medical Research Institute, LLCMiami, United States
- Deluxe Health CenterMiami Lakes, United States
- Sarasota Clinical ResearchSarasota, United States
- GCP, Global Clinical ProfessionalsSt. Petersburg, United States
- Advanced Clinical Research Institute (ACRI) - FloridaTampa, United States
- Centricity Research Columbus DermatologyColumbus, United States
- Endeavor HealthSkokie, United States
- The South Bend Clinic - AvacareSouth Bend, United States
- Allergy and Asthma Specialists PSCOwensboro, United States
- John Hopkins UniversityBaltimore, United States
- Institute for Asthma and AllergyWheaton, United States
- Michigan Center for Research Co., LLCClarkston, United States
- Respiratory Medicine Research Institute of Michigan PLCYpsilanti, United States
- Midwest Clinical ResearchSt Louis, United States
And 106 more, listed on the interactive page.