Cholinergic Urticaria, Cold Contact Urticaria, Cold Urticaria, Symptomatic Dermatographism, Symptomatic Dermographism
Conditions
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.
Interventions
DRUGCDX-0159
Administered intravenously
Sponsors
Celldex Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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 2. 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 3. 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 4. Willing and able to comply with all study requirements and procedures including completion of a daily medication diary and questionnaires Key
Exclusion criteria
1. A clearly defined diagnosis of hives or angioedema other than chronic urticaria. 2. Receipt of prior biologic therapy (e.g.: omalizumab, dupilumab, ligelizumab) within past 3 months 3. 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 4. Active COVID-19 infection 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by the incidence and severity of adverse events | From Day 1 through week 12 | Safety of a single dose of CDX-0159 as determined by adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| For patients with Symptomatic Dermographism, change in provocation thresholds | From Day 1 to Day 85 | 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) | From Day 1 to Day 85 | Changes from baseline and percentage of responders as measured by UASprovo |
| Changes from baseline in Urticaria Control Test (UCT) | From Day 1 to Day 85 | Changes from baseline and percentage of responders for the UCT and modified UCT |
| For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT) | From Day 1 to Day 85 | The change from baseline in critical temperature thresholds over time as determined by provocation testing using the TempTest® |
| Pharmacokinetic Evaluation | From Day 1 to Day 85 | CDX-0159 concentrations will be measured. |
| Immunogenicity Evaluation | From Day 1 to Day 85 | Patients will be monitored for the development of anti-drug antibodies. |
| Blood Biomarkers | From Day 1 to Day 85 | Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in Stem Cell Factor |
Countries
Germany
Outcome results
None listed