Chronic Spontaneous Urticaria
Conditions
Keywords
CDX-0159, barzolvolimab
Brief summary
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Spontaneous Urticaria
Detailed description
The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab in patients with Chronic Spontaneous Urticaria. There is a screening period of up to 4 weeks, followed by a 16-week placebo-controlled treatment period (Placebo-Controlled Treatment Phase) where patients will receive either barzolvolimab at a dose level of 75mg, 150mg, or 300mg, or placebo, and then a 36-week treatment period where all patients will receive barzolvolimab. Patients who receive barzolvolimab 75mg or placebo in the placebo-controlled treatment phase will be re-randomized to receive either barzolvolimab 150mg or 300mg in the active treatment phase.
Interventions
BIOLOGICALbarzolvolimab
Subcutaneous Administration
DRUGMatching Placebo
Subcutaneous Administration
Sponsors
Celldex Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria: 1. Males and females, \>/= 18 years of age. 2. Diagnosis of chronic spontaneous urticaria (CSU) \>/= 6 months. 3. Diagnosis of 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 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 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. Key
Exclusion criteria
1. Women who are pregnant or nursing. 2. Clearly defined cause for chronic urticaria. 3. Active, pruritic skin condition in addition to CSU. 4. Medical condition that would cause additional risk or interfere with study procedures. 5. Known active HIV, hepatitis B or hepatitis C infection. 6. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid vaccination during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine. 7. History of anaphylaxis 8. Prior treatment with barzolvolimab There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline to Week 12 of UAS7 (Urticaria Activity Score) | From baseline to Day 85 (Week 12) | Evaluate efficacy of barzolvolimab on urticaria activity as measured by urticaria activity score (UAS). UAS7 is the sum of the itch severity score measured over 7 days (ISS7) and the hives severity score measured over 7 days (HSS7). The possible range of UAS7 is 0 - 42. Itch severity score (ISS) is on a scale of 0 - 3. 0 = None 1. = mild (present, but not annoying or troublesome) 2. = moderate (troublesome, but does not interfere with normal daily activity or sleep) 3. = intense (severe itch, which is sufficiently troublesome to interfere with normal daily activity or sleep) Hives severity score (HSS) is on a scale of 0 - 3. 0 = None 1. = less than 20 hives 2. = between 20 and 50 hives 3. = greater than 50 hives |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline to Week 12 of ISS7 (Itch Severity Score) | From baseline to Day 85 (Week 12) | ISS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21. |
| Mean change from baseline to Week 12 of HSS7 (Hives Severity Score) | From baseline to Day 85 (Week 12) | HSS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21. |
| Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score) | From baseline to Day 85 (Week 12) | AAS captures the presences of swelling over the last 24 hours and rates the severity with 5 questions. The possible range of the weekly score is 0 - 105. |
Countries
Bulgaria, Estonia, Georgia, Germany, Hungary, Poland, South Africa, Spain, United States
Outcome results
None listed