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

Phase 1

Completed

• Conditions: Cold Urticaria; Cold Contact Urticaria; Symptomatic Dermatographism; Symptomatic Dermographism; Cholinergic Urticaria
• Interventions: Drug: CDX-0159

• Registration Number: NCT04548869
• Lead Sponsor: Celldex Therapeutics

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.

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Study Start: 2020-11-24
• Primary Completion: 2022-12-16
• Status Verified: 2023-05
• Study Completion: 2023-05-12
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CDX-0159	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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®
Blood Biomarkers	From Day 1 to Day 85	Pre-treatment and post-treatment blood samples will be collected and analyzed for changes in tryptase
Pharmacokinetic Evaluation	From Day 1 to Day 85	CDX-0159 concentrations will be measured.
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 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
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®
Immunogenicity Evaluation	From Day 1 to Day 85	Patients will be monitored for the development of anti-drug antibodies.

Trial Locations

Locations (1)

Charite University; 🇩🇪 Berlin, Germany