Clinical trial NCT04548869: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cold Urticaria
Cold Contact Urticaria
Symptomatic Dermographism
Symptomatic Dermatographism
Cholinergic Urticaria
Lead sponsor: Celldex Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Safety as assessed by the incidence and severity of adverse events
timeFrame: From Day 1 through week 12
Secondary outcomes:
measure: For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT)
timeFrame: From Day 1 to Day 85
measure: For patients with Symptomatic Dermographism, change in provocation thresholds
timeFrame: From Day 1 to Day 85
measure: For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo)
timeFrame: From Day 1 to Day 85
measure: Changes from baseline in Urticaria Control Test (UCT)
timeFrame: From Day 1 to Day 85
measure: Blood Biomarkers
timeFrame: From Day 1 to Day 85
measure: Blood Biomarkers
timeFrame: From Day 1 to Day 85
measure: Pharmacokinetic Evaluation
timeFrame: From Day 1 to Day 85
measure: Immunogenicity Evaluation
timeFrame: From Day 1 to Day 85
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References: