A Study of CDX-0159 in Patients With Chronic Inducible Urticaria
- Conditions
- Chronic Inducible Urticaria
- Interventions
- Biological: barzolvolimabDrug: Matching Placebo
- Registration Number
- NCT05405660
- Lead Sponsor
- Celldex Therapeutics
- 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 Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.
- 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 Inducible Urticaria (Cold Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) who remain symptomatic despite the use of H1-antihistamines.
There is a screening period of up to 4 weeks, followed by a 20-week treatment period where patients will receive either barzolvolimab 150mg, 300mg or placebo, and then a 24-week follow up period where all patients are observed.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 196
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description barzolvolimab 150 mg in patients with Symptomatic Dermographism barzolvolimab barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks barzolvolimab 300 mg in patients with Symptomatic Dermographism barzolvolimab barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks Placebo Comparator in patients with Symptomatic Dermographism Matching Placebo Placebo injection subcutaneous every 4 weeks for 20 weeks barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria barzolvolimab barzolvolimab 150 mg injection subcutaneous every 4 weeks for 20 weeks barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria barzolvolimab barzolvolimab 300 mg injection subcutaneous every 8 weeks for 20 weeks Placebo Comparator in patients with Chronic Inducible Cold Urticaria Matching Placebo Placebo injection subcutaneous every 4 weeks for 20 weeks
- Primary Outcome Measures
Name Time Method Percentage of patients with a negative provocation test at week 12 From baseline to week 12 Percentage of patients with a negative provocation test for Cold Inducible Urticaria \[ColdU\] or Symptomatic Dermographism \[SD\]) at week 12
* For ColdU patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at ≤ 4°C after provocation using TempTest®
* For SD patients, a negative provocation test is defined as absence of wheals at the provocation site within 10 min at 0 pins after provocation using the FricTest®
- Secondary Outcome Measures
Name Time Method Change in worst itch reported after provocation in both SD and ColdU From baseline to week 12 Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD and ColdU combined
Change in provocation threshold for SD From baseline to week 12 Mean change from baseline to Week 12 in Critical Friction Threshold (CFT) in patients with SD
CFT is the threshold pin number at which wheals are triggered, assessed at the 10-minute markChange in worst itch reported after provocation for ColdU From baseline to week 12 Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with ColdU
Change in provocation threshold and itch for ColdU From baseline to week 12 Mean change from baseline to week 12 in critical temperature threshold (CTT) in patients with ColdU
CTT is defined as threshold temperature at which wheals are triggered (highest temperature for cold), assessed at the 10-minute markCombined patients with a negative provocation test at week 12 From baseline to week 12 Percentage of combined patients with a negative TempTest (ColdU) or FricTest (SD) at week 12
Change in worst itch reported after provocation for SD From baseline to week 12 Mean change in worst itch reported by numerical rating scale after provocation testing from baseline to week 12 in patients with SD
Percentage of patients experiencing adverse events From baseline to week 20 Percentage of patients experiencing treatment-emergent adverse events (TEAE) examined by ColdU patients, SD patients and in combination. A TEAE is any untoward medical occurrence in a patient administered a study treatment.
Trial Locations
- Locations (75)
Clinical Research Center of Alabama
🇺🇸Birmingham, Alabama, United States
Allervie Clinical Research
🇺🇸Montgomery, Alabama, United States
One of a Kind Clinical Research Center, LLC
🇺🇸Paradise Valley, 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
Sarasota Clinical Research
🇺🇸Sarasota, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Dawes Fretzin Dermatology Group, LLC
🇺🇸Indianapolis, Indiana, United States
Scroll for more (65 remaining)Clinical Research Center of Alabama🇺🇸Birmingham, Alabama, United States