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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT04538794

Public ClinicalTrials.gov record NCT04538794. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 3:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT04538794
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Celldex Therapeutics
Industry
Enrollment
45 participants

Conditions and interventions

Interventions

  • CDX-0159 Drug
  • Normal Saline Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 23, 2020
Primary completion
Jan 16, 2023
Completion
Jan 16, 2023
Last update posted
Jul 18, 2023

2020 – 2023

United States locations

U.S. sites
13
U.S. states
12
U.S. cities
13
Facility City State ZIP Site status
Clinical Research Center of Alabama Birmingham Alabama 35209
Arizona Allergy & Immunology Research Gilbert Arizona 85234
Sarasota Clinical Research Sarasota Florida 34239
ForCare Clinical Research Tampa Florida 33613
Treasure Valley Medical Research Boise Idaho 83706
Midwest Allergy, Sinus and Asthma, SC Normal Illinois 61761
Dawes Fretzin Clinical Research Indianapolis Indiana 46250
Kanarek Allergy Asthma & Immunology Overland Park Kansas 66211
Bernstein Clinical Research Center, LLC Cincinnati Ohio 45231
Vital Prospects Clinical Research Institute, PC Tulsa Oklahoma 74136-7028
Asthma, Nasal Disease & Allergy Research Center of New England East Providence Rhode Island 02914
National Allergy and Asthma Research, LLC North Charleston South Carolina 29420
AARA Research Dallas Texas 75231

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04538794, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 18, 2023 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04538794 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →