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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04548869
Recruitment Status : Active, not recruiting
First Posted : September 16, 2020
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
Celldex Therapeutics

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

Condition or disease Intervention/treatment Phase
Cold Urticaria Cold Contact Urticaria Symptomatic Dermographism Symptomatic Dermatographism Cholinergic Urticaria Drug: CDX-0159 Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 24, 2020
Actual Primary Completion Date : December 16, 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: CDX-0159
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
 Drug: CDX-0159
Administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Safety as assessed by the incidence and severity of adverse events [ Time Frame: From Day 1 through week 12 ]
    Safety of a single dose of CDX-0159 as determined by adverse events


Secondary Outcome Measures :
  1. For patients with Cold Contact Urticaria, Change in Critical Temperature Thresholds (CTT) [ Time Frame: From Day 1 to Day 85 ]
    The change from baseline in critical temperature thresholds over time as determined by provocation testing using the TempTest®

  2. For patients with Symptomatic Dermographism, change in provocation thresholds [ Time Frame: From Day 1 to Day 85 ]
    The change from baseline in provocation thresholds over time as determined by provocation testing using the FricTest®

  3. For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo) [ Time Frame: From Day 1 to Day 85 ]
    Changes from baseline and percentage of responders as measured by UASprovo

  4. Changes from baseline in Urticaria Control Test (UCT) [ Time Frame: From Day 1 to Day 85 ]
    Changes from baseline and percentage of responders for the UCT and modified UCT

  5. Blood Biomarkers [ Time Frame: From Day 1 to Day 85 ]
    Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in Stem Cell Factor

  6. Blood Biomarkers [ Time Frame: From Day 1 to Day 85 ]
    Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase

  7. Pharmacokinetic Evaluation [ Time Frame: From Day 1 to Day 85 ]
    CDX-0159 concentrations will be measured.

  8. Immunogenicity Evaluation [ Time Frame: From Day 1 to Day 85 ]
    Patients will be monitored for the development of anti-drug antibodies.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548869


Locations
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Germany
Charite University
Berlin, Germany, 10117
Sponsors and Collaborators
Celldex Therapeutics
More Information
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Responsible Party: Celldex Therapeutics
ClinicalTrials.gov Identifier: NCT04548869    
Other Study ID Numbers: CDX0159-03
2020-002792-35 ( EudraCT Number )
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases