A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

NCT06455202
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
976
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Lead sponsor
Celldex Therapeutics
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Start date
2024-07-19
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Number of sites
245
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Summary
The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.
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Acronym
EMBARQ-CSU2
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Short title
A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
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Official title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients With Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU2)
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-04-01
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First posted
2024-06-12
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Registry last updated
2026-03-25
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Primary completion date
2026-10-01
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Start date
2024-07-19
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Actual participants
976
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Participants
976
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
245
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Celldex Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06455202
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ClinicalTrials.gov ID
NCT06455202
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score)

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    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.

  1. Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The ISS7 is the itch severity score for 7 days, the scores range from 0 to 21.

  2. Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    The ISS7 and HSS7 combined together make up the UAS7 scoring system to evaluate urticaria signs and symptoms. The HSS7 score is the wheal/hives severity score for 7 days, the scores range from 0 to 21.

  3. Percentage of patients with UAS7=0 at Week 12

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12.

  4. Percentage of participants with UAS7 ≤ 6 at Week 12

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7≤6) at Week 12.

  5. Percentage of participants with AAS7 > 0 at baseline with AAS7 = 0 at Week 12

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    Proportion of participants with AAS7 \> 0 at Day 1 who achieved complete control (AAS7 = 0) at Week 12 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.

  6. Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS) in participants who did not respond to or did not tolerate omalizumab. 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.

  7. Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12

    Timeframe: From Day 1 (first dose) to Day 85 (Week 12)

    Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12 in participants who did not respond to or did not tolerate omalizumab.

  8. Incidence of Treatment-Emergent Adverse Events

    Timeframe: From Day 1 (first dose) to Day 477 (Week 68)

    Occurrence of treatment emergent adverse events and serious adverse events during the study.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  1. Males and females, >/= 18 years of age.

  2. Chronic spontaneous urticaria (CSU) >/= 6 months prior to Screening (Visit 1).

  3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:

    1. The presence of hives for >/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
    2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for >/= 4 weeks prior to study treatment.
    3. UAS7 of >/= 16 and ISS7 of >/= 8 during the 7 days prior to study treatment.

  4. Normal blood counts and liver function tests.

  5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.

  6. Willing and able to complete a daily symptom electronic diary and comply with study visits.

  7. Participants with and without prior biologic experience are eligible.

Key Exclusion Criteria:

  1. Women who are pregnant or nursing.
  2. Chronic urticaria whose predominant manifestation is due to CIndU.
  3. Other diseases associated with urticaria.
  4. Active pruritic skin condition in addition to CSU.
  5. Medical condition that would cause additional risk or interfere with study procedures.
  6. Known HIV, hepatitis B or hepatitis C infection.
  7. Vaccination of a live vaccine within 30 days prior to Screening (Visit 1) (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or authorized COVID-19 vaccine.
  8. History of anaphylaxis
  9. Prior treatment with barzolvolimab

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Sources for eligibility
clinicaltrials.gov

  • Allervie Clinical Research - CullmanCullman, United States
  • Research Solutions of Arizona PCLitchfield Park, United States
  • Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.Scottsdale, United States
  • Center for Dermatology & Plastic SurgeryScottsdale, United States
  • Kern Research, Inc.Bakersfield, United States
  • UCLA Clinical Trials Contracts & Strategic RelationsLos Angeles, United States
  • California Allergy and Asthma Medical GroupLos Angeles, United States
  • LA Universal Research Center, Inc.Los Angeles, United States
  • Allergy and Asthma Associates of Southern CalMission Viejo, United States
  • Huntington Asthma & Allergy CenterPasadena, United States
  • Apex Clinical ResearchSan Diego, United States
  • WR-MCCRSan Diego, United States
  • University Clinical TrialsSan Diego, United States
  • Clinical Science InstituteSanta Monica, United States
  • Raffi Tachdjian MD, IncSanta Monica, United States
  • Clarity Dermatology, PLLCCastle Rock, United States
  • Asthma and Allergy AssociatesColorado Springs, United States
  • Driven Research LLCCoral Gables, United States
  • Palm Beach Dermatology GroupDelray Beach, United States
  • Dolphin Medical ResearchDoral, United States
  • South FL Clinical Research LLCMiami, United States
  • Dade Florida Clinical Research CenterMiami, United States
  • Deluxe Health CenterMiami Lakes, United States
  • Revival Clinical ResearchOrlando, United States
  • International Clinical Research - FL LLCSanford, United States

And 220 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-513210-36-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)