A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
- Conditions
- Chronic Spontaneous Urticaria
- Interventions
- Biological: Matching placebo
- Registration Number
- NCT06445023
- Lead Sponsor
- Celldex Therapeutics
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 915
-
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.
Key
- 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.
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo then barzolvolimab 150 mg barzolvolimab Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks. barzolvolimab 150 mg barzolvolimab barzolvolimab given once as a 300 mg subcutaneous injection followed by 150 mg administered every 4 weeks for 52 weeks barzolvolimab 300 mg barzolvolimab barzolvolimab given once as a 450 mg subcutaneous injection followed by 300 mg administered every 8 weeks for 52 weeks Placebo then barzolvolimab 150 mg Matching placebo Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 300 mg followed by 150 mg administered every 4 weeks for 28 weeks. Placebo then barzolvolimab 300 mg Matching placebo Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks. Placebo then barzolvolimab 300 mg barzolvolimab Placebo injection subcutaneous every 4 weeks for 24 weeks and then barzolvolimab 450 mg followed by 300 mg administered every 8 weeks for 28 weeks.
- Primary Outcome Measures
Name Time Method Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) 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.
- Secondary Outcome Measures
Name Time Method Percentage of participants with UAS7 = 0 at Week 12 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.
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score) 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.
Percentage of participants with UAS7 ≤ 6 at Week 12 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.
Mean change from baseline in UAS7 at Week 4 From Day 1 (first dose) to Day 29 (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.Proportion of participants with UAS7 = 0 in participants refractory to omalizumab treatment at Week 12 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.
Mean change from baseline in UAS7 in participants refractory to omalizumab treatment at Week 12 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.Mean change from baseline in UAS7 at Week 24 From Day 1 (first dose) to Day 169 (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.Incidence of Treatment-Emergent Adverse Events From Day 1 (first dose) to Day 477 (Week 68) Occurrence of treatment emergent adverse events and serious adverse events during the study.
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score) 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.
Percentage of participants with UAS7 = 0 at Week 24 From Day 1 (first dose) to Day 169 (Week 24) Proportion of participants who achieve complete absence of hives and itch (UAS7 = 0) at Week 24.
Trial Locations
- Locations (195)
Cahaba Dermatology Skin Health Center
🇺🇸Birmingham, Alabama, United States
Clear Dermatology & Aesthetics Center Scottsdale
🇺🇸Scottsdale, Arizona, United States
First OC Dermatology - Fountain Valley
🇺🇸Fountain Valley, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Cura Clinical Research
🇺🇸Oxnard, California, United States
Allergy and Asthma Consultants
🇺🇸Redwood City, California, United States
West Dermatology Research Center
🇺🇸San Diego, California, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Integrated Research of Inland, Inc.
🇺🇸Upland, California, United States
Western States Clinical Research Inc
🇺🇸Wheat Ridge, Colorado, United States
Scroll for more (185 remaining)Cahaba Dermatology Skin Health Center🇺🇸Birmingham, Alabama, United StatesJennifer PerryContactjperry@cahabaderm.com