Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04548869
Other study ID # CDX0159-03
Secondary ID 2020-002792-35
Status Completed
Phase Phase 1
First received
Last updated
Start date November 24, 2020
Est. completion date May 12, 2023

Study information

Verified date May 2023
Source Celldex Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 12, 2023
Est. primary completion date December 16, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Drug:
CDX-0159
Administered intravenously

Locations

Country Name City State
Germany Charite University Berlin

Sponsors (1)

Lead Sponsor Collaborator
Celldex Therapeutics

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety as assessed by the incidence and severity of adverse events Safety of a single dose of CDX-0159 as determined by adverse events From Day 1 through week 12
Secondary 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® From Day 1 to Day 85
Secondary 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® From Day 1 to Day 85
Secondary For patients with Cholinergic Urticaria, changes in baseline Urticaria Activity Score Provocation (UASprovo) Changes from baseline and percentage of responders as measured by UASprovo From Day 1 to Day 85
Secondary Changes from baseline in Urticaria Control Test (UCT) Changes from baseline and percentage of responders for the UCT and modified UCT From Day 1 to Day 85
Secondary Blood Biomarkers Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in Stem Cell Factor From Day 1 to Day 85
Secondary Blood Biomarkers Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase From Day 1 to Day 85
Secondary Pharmacokinetic Evaluation CDX-0159 concentrations will be measured. From Day 1 to Day 85
Secondary Immunogenicity Evaluation Patients will be monitored for the development of anti-drug antibodies. From Day 1 to Day 85
See also
  Status Clinical Trial Phase
Completed NCT04853992 - Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria Phase 2
Completed NCT02012387 - Efficacy Study of Omalizumab in Cholinergic Urticaria Phase 2
Recruiting NCT06201780 - Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria N/A
Completed NCT03749148 - Cholinergic Urticaria - Efficacy of Dupilumab Phase 2
Terminated NCT04513548 - Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria Phase 1