NCT04538794

A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of CDX-0159 as Add-on Therapy in Patients With Chronic Spontaneous Urticaria

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (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 multiple doses of CDX-0159 in patients with Chronic Spontaneous Urticaria.

Detailed description

The purpose of the study is to explore the safety, pharmacodynamics, and pharmacokinetics of ascending doses of CDX-0159 in patients with Chronic Spontaneous Urticaria who remain symptomatic despite treatment with antihistamines. There is a screening period of up to 2 weeks, a 12-week double-blind treatment period and a 12-week follow-up period after treatment. Patients will receive multiple doses of CDX-0159 or placebo as add on therapy to their antihistamine.

Conditions

• Chronic Spontaneous Urticaria

Interventions

Type	Name	Description
DRUG	CDX-0159	Administered intravenously
DRUG	Normal Saline	Administered intravenously

Timeline

• Start date: 2020-09-24
• Primary completion: 2023-01-17
• Completion: 2023-01-17
• First posted: 2020-09-04
• Last updated: 2023-07-19

Locations

14 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study