A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)
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.
Study details:
This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Males and females, ">/= 18 years of age.
- Chronic spontaneous urticaria (CSU) ">/= 6 months prior to Screening (Visit 1).
- CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
- The presence of hives for ">/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
- Must be on a stable regimen of second generation non-sedating H1-antihistamine for ">/= 4 weeks prior to study treatment.
- UAS7 of ">/= 16 and ISS7 of ">/= 8 during the 7 days prior to study treatment.
- Normal blood counts and liver function tests.
- Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
- Willing and able to complete a daily symptom electronic diary and comply with study visits.
- Participants with and without prior biologic experience are eligible.
Exclusion criteria
- Women who are pregnant or nursing.
- Chronic urticaria whose predominant manifestation is due to CIndU.
- Other diseases associated with urticaria.
- Active pruritic skin condition in addition to CSU.
- Medical condition that would cause additional risk or interfere with study procedures.
- Known HIV, hepatitis B or hepatitis C infection.
- 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.
- History of anaphylaxis
- Prior treatment with barzolvolimab
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT06455202
Intervention or treatment
BIOLOGICAL: barzolvolimab
BIOLOGICAL: Matching placebo
Conditions
- Chronic Spontaneous Urticaria
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Research sites nearby
Closest Location:
Novatrials
Select from list below to view details:
Novatrials
Charlestown, New South Wales, Australia
Skin and Cancer Foundation - The Skin Hospital
Darlinghurst, New South Wales, Australia
St George Dermatology and Skin Cancer Center
Kogarah, New South Wales, Australia
Momentum Clinical Research Darlinghurst
Sydney, New South Wales, Australia
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Who is running the clinical trial?
Celldex Therapeutics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: barzolvolimab 150 mg
| Biological: barzolvolimab |
EXPERIMENTAL: barzolvolimab 300 mg
| Biological: barzolvolimab |
EXPERIMENTAL: Placebo then barzolvolimab 150 mg
| Biological: barzolvolimab, Biological: Matching placebo |
EXPERIMENTAL: Placebo then barzolvolimab 300 mg
| Biological: barzolvolimab, Biological: Matching placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) | 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. | From Day 1 (first dose) to Day 85 (Week 12) |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to Week 12 of ISS7 (Itch Severity Score) | 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. | From Day 1 (first dose) to Day 85 (Week 12) |
| Mean change from baseline to Week 12 of HSS7 (Hives Severity Score) | 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. | From Day 1 (first dose) to Day 85 (Week 12) |
| Percentage of patients with UAS7=0 at Week 12 | Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 12. | From Day 1 (first dose) to Day 85 (Week 12) |
| Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at 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. | From Day 1 (first dose) to Day 85 (Week 12) |
| Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at 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. | From Day 1 (first dose) to Day 85 (Week 12) |
| Percentage of participants with UAS7 ≤ 6 at Week 12 | Proportion of participants who achieve control of their urticaria signs and symptoms (UAS7 \</=6) at Week 12. | From Day 1 (first dose) to Day 85 (Week 12) |
| Mean change from baseline in UAS7 at Week 4 | 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. | From Day 1 (first dose) to Day 29 (Week 4) |
| Mean change from baseline in UAS7 at Week 24 | 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. | From Day 1 (first dose) to Day 169 (Week 24) |
| Percentage of participants with UAS7 = 0 at Week 24 | Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24. | From Day 1 (first dose) to Day 169 (Week 24) |
| Incidence of Treatment-Emergent Adverse Events | Occurrence of treatment emergent adverse events and serious adverse events during the study. | From Day 1 (first dose) to Day 477 (Week 68) |
References
Clinical Trials Gov: A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)Other trials to consider
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