Back to resultsA Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
Primary Purpose
Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
CDX-0159
Sponsored by
About this trial
This is an interventional treatment trial for Cold Urticaria
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines
- Diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines
- During screening, in clinic, for Cold Contact Urticaria, patients must have a positive cold stimulation test, for Symptomatic Dermographism, patients must have a positive FricTest®, and for Cholinergic Urticaria, patients must have a positive pulse-controlled ergometry (PCE) provocation test
- On stable dose of antihistamines
- Other than a diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation
- Female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment
- Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires
Key Exclusion Criteria:
- A clearly defined diagnosis of hives or angioedema other than chronic urticaria.
- Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months
- Treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives
- Active COVID-19 infection
- HIV, hepatitis B or hepatitis C infection
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Sites / Locations
- Charite University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CDX-0159
Arm Description
20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159
Outcomes
Primary Outcome Measures
Safety as assessed by the incidence and severity of adverse events
Safety of a single dose of CDX-0159 as determined by adverse events
Secondary Outcome Measures
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®
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®
For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)
Changes from baseline and percentage of responders as measured by UASprovo
Changes from baseline in Urticaria Control Test (UCT)
Changes from baseline and percentage of responders for the UCT and modified UCT
Blood Biomarkers
Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in Stem Cell Factor
Blood Biomarkers
Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase
Pharmacokinetic Evaluation
CDX-0159 concentrations will be measured.
Immunogenicity Evaluation
Patients will be monitored for the development of anti-drug antibodies.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04548869
Brief Title
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
Official Title
An Open Label, Phase 1 Single Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add on Therapy in Patients With Cold Contact Urticaria, Symptomatic Dermographism and Cholinergic Urticaria
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
May 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celldex Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Urticaria, Cold Contact Urticaria, Symptomatic Dermographism, Symptomatic Dermatographism, Cholinergic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CDX-0159
Arm Type
Experimental
Arm Description
20 patients with Cold Contact Urticaria, 10 patients with Symptomatic Dermographism, and 10 patients with Cholinergic Urticaria will be enrolled and treated with a single dose of CDX-0159
Intervention Type
Drug
Intervention Name(s)
CDX-0159
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Safety as assessed by the incidence and severity of adverse events
Description
Safety of a single dose of CDX-0159 as determined by adverse events
Time Frame
From Day 1 through week 12
Secondary Outcome Measure Information:
Title
For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)
Description
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
Title
For patients with Symptomatic Dermographism, change in provocation thresholds
Description
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
Title
For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)
Description
Changes from baseline and percentage of responders as measured by UASprovo
Time Frame
From Day 1 to Day 85
Title
Changes from baseline in Urticaria Control Test (UCT)
Description
Changes from baseline and percentage of responders for the UCT and modified UCT
Time Frame
From Day 1 to Day 85
Title
Blood Biomarkers
Description
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
Title
Blood Biomarkers
Description
Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase
Time Frame
From Day 1 to Day 85
Title
Pharmacokinetic Evaluation
Description
CDX-0159 concentrations will be measured.
Time Frame
From Day 1 to Day 85
Title
Immunogenicity Evaluation
Description
Patients will be monitored for the development of anti-drug antibodies.
Time Frame
From Day 1 to Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria which does not respond to antihistamines
Diagnosis for ≥ 3 months; symptoms of both hive (wheal) and itch/burning/painful sensation despite concurrent use of anti-histamines
During screening, in clinic, for Cold Contact Urticaria, patients must have a positive cold stimulation test, for Symptomatic Dermographism, patients must have a positive FricTest®, and for Cholinergic Urticaria, patients must have a positive pulse-controlled ergometry (PCE) provocation test
On stable dose of antihistamines
Other than a diagnosis of Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria, no other conditions which would introduce additional risk factors or would interfere with the study procedures, as determined by the investigator, based on a medical evaluation
Female and male patients must use highly effective contraception from the time of the screening visit and for at least 150 days after receipt of study treatment
Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires
Key Exclusion Criteria:
A clearly defined diagnosis of hives or angioedema other than chronic urticaria.
Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months
Treatment with immunosuppressives (e.g. systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus and mycophenolate mofetil, hydroxychloroquine or others) within 4 weeks or 5 half lives
Active COVID-19 infection
HIV, hepatitis B or hepatitis C infection
There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.
Facility Information:
Facility Name
Charite University
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria
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