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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Celldex Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cold Urticaria
• Cold Contact Urticaria
• Symptomatic Dermographism
• Symptomatic Dermatographism
• Cholinergic Urticaria

Interventions

Type	Name	Description
DRUG	CDX-0159	Administered intravenously

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-12-16
• Completion: 2023-05-12
• First posted: 2020-09-16
• Last updated: 2023-05-17

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study