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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
208
Subcutaneous Administration
Subcutaneous Administration
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). 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
Time frame: From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of ISS7 (Itch Severity Score)
ISS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Time frame: From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of HSS7 (Hives Severity Score)
HSS7 is derived by adding up the daily scores over 7 days. The possible range of the weekly score is 0 -21.
Time frame: From baseline to Day 85 (Week 12)
Mean change from baseline to Week 12 of AAS7 (Angioedema Activity Score)
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.
Time frame: From baseline to Day 85 (Week 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Clinical Research Center of Alabama dba Allervie Clinical Research
Birmingham, Alabama, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
Little Rock Allergy & Asthma CRC
Little Rock, Arkansas, United States
Kern Research, Inc
Bakersfield, California, United States
Allergy & Asthma Consultants
Redwood City, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Allergy & Asthma Specialists, PSC
Owensboro, Kentucky, United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States
Chesapeake Clinical Research
White Marsh, Maryland, United States
...and 46 more locations