This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
This study is an open label Phase 1 study evaluating the safety, pharmacokinetics, and pharmacodynamics of a single dose of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria who remain symptomatic despite treatment with antihistamines. Twenty patients with Cold Contact Urticaria, ten patients with Symptomatic Dermographism, and ten patients with Cholinergic Urticaria will be enrolled in four separate cohorts for a total of 40 patients. Prospective patients will be screened with tests in clinic as well as daily at home diaries for 2 weeks prior to enrollment. CDX-0159 will be administered intravenously on Day 1. Post-treatment, patients will be followed for 12 weeks with an optional longer term follow up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Administered intravenously
Charite University
Berlin, Germany
Safety as assessed by the incidence and severity of adverse events
Safety of a single dose of CDX-0159 as determined by adverse events
Time frame: From Day 1 through week 12
For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)
The change from baseline in critical temperature thresholds over time as determined by provocation testing using the TempTest®
Time frame: From Day 1 to Day 85
For patients with Symptomatic Dermographism, change in provocation thresholds
The change from baseline in provocation thresholds over time as determined by provocation testing using the FricTest®
Time frame: From Day 1 to Day 85
For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)
Changes from baseline and percentage of responders as measured by UASprovo
Time frame: From Day 1 to Day 85
Changes from baseline in Urticaria Control Test (UCT)
Changes from baseline and percentage of responders for the UCT and modified UCT
Time frame: From Day 1 to Day 85
Blood Biomarkers
Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in Stem Cell Factor
Time frame: From Day 1 to Day 85
Blood Biomarkers
Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Day 1 to Day 85
Pharmacokinetic Evaluation
CDX-0159 concentrations will be measured.
Time frame: From Day 1 to Day 85
Immunogenicity Evaluation
Patients will be monitored for the development of anti-drug antibodies.
Time frame: From Day 1 to Day 85