A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the safety of CDX-0159 in patients with Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celldex Therapeutics

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.