RECRUITING

A Phase 3 Study of Barzolvolimab in Participants with Chronic Spontaneous Urticaria

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Conditions

Chronic Spontaneous UrticariaCDX-0159barzolvolimabCSUurticaria activity scoreitch severity scorehives severity score

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to establish the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) inadequately controlled by non-sedating second generation H1-antihistamines in comparison to placebo.

Official Title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab in Patients with Chronic Spontaneous Urticaria Who Remain Symptomatic Despite H1 Antihistamine Treatment (EMBARQ-CSU1)

Quick Facts

Study Start:2024-07-11
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06445023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males and females, \>/= 18 years of age.
  2. 2. Diagnosis of chronic spontaneous urticaria (CSU) \>/= 6 months.
  3. 3. CSU despite the use of a stable regimen of second generation non-sedating H1-antihistamine as defined by:
  4. 1. The presence of hives for \>/= 6 weeks at any time prior to Visit 1 despite the use of non-sedating H1-antihistamines.
  5. 2. Must be on a stable regimen of second generation non-sedating H1-antihistamine for \>/= 4 weeks prior to study treatment.
  6. 3. UAS7 of \>/= 16 and ISS7 of \>/= 8 during the 7 days prior to treatment.
  7. 4. Normal blood counts and liver function tests.
  8. 5. Both males and females of child-bearing potential must agree to use highly effective contraceptives during the study and for 150 days after treatment.
  9. 6. Willing and able to complete a daily symptom electronic diary and comply with study visits.
  10. 7. Participants with and without prior biologic experience are eligible.
  1. 1. Women who are pregnant or nursing.
  2. 2. Chronic inducible urticaria that would confound the study endpoints.
  3. 3. Other diseases associated with urticaria.
  4. 4. Active pruritic skin condition in addition to CSU.
  5. 5. Medical condition that would cause additional risk or interfere with study procedures.
  6. 6. Known HIV, hepatitis B or hepatitis C infection.
  7. 7. Vaccination of a live vaccine within 2 months prior to study treatment (subjects must agree to avoid live vaccinations during the study). Inactivated vaccines are allowed such as seasonal influenza injection or COVID-19 vaccine.
  8. 8. History of anaphylaxis
  9. 9. Prior treatment with barzolvolimab

Contacts and Locations

Study Contact

Celldex Therapeutics
CONTACT
844-723-9363
clinicaltrials@celldex.com

Study Locations (Sites)

Cahaba Dermatology Skin Health Center
Birmingham, Alabama, 35244
United States
Clear Dermatology & Aesthetics Center Scottsdale
Scottsdale, Arizona, 85255
United States
First OC Dermatology - Fountain Valley
Fountain Valley, California, 92708
United States
Dermatology Research Associates
Los Angeles, California, 90045
United States
Cura Clinical Research
Oxnard, California, 93030
United States
Allergy and Asthma Consultants
Redwood City, California, 94063
United States
West Dermatology Research Center
San Diego, California, 92121
United States
Therapeutics Clinical Research
San Diego, California, 92123
United States
Integrated Research of Inland, Inc.
Upland, California, 91786
United States
Western States Clinical Research Inc
Wheat Ridge, Colorado, 80033
United States
Encore Medical Research Boynton Beach
Boynton Beach, Florida, 33436
United States
Florida Academic Centers Research
Coral Gables, Florida, 33134
United States
Direct Helpers Research Center
Hialeah, Florida, 33012
United States
GSI Clinical Research
Margate, Florida, 33063
United States
International Dermatology Research Inc - Miami
Miami, Florida, 33144
United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176
United States
GCP Global Clinical Professionals, LLC
Saint Petersburg, Florida, 33705
United States
Sarasota Clinical Research
Sarasota, Florida, 34239
United States
Alliance Clinical Research of Tampa
Tampa, Florida, 33615
United States
DS Research - 1005 E. Lewis & Clark Pkwy Indiana Location
Clarksville, Indiana, 47129
United States
Dawes Fretzin Clinical Research Group-7910 N Shadeland Ave
Indianapolis, Indiana, 46250
United States
DS Research of Kentucky, LLC
Louisville, Kentucky, 40241
United States
Allergy and Asthma Specialists PSC
Owensboro, Kentucky, 42301
United States
Clinical Trials Management LLC - Southshore Office
Metairie, Louisiana, 70006
United States
Institute For Asthma and Allergy
Wheaton, Maryland, 20902
United States
David Fivenson MD Dermatolgy PLLC
Ann Arbor, Michigan, 48103
United States
Oakland Hills Dermatology
Auburn Hills, Michigan, 48326
United States
Resp Medicine Research Institute of MI
Ypsilanti, Michigan, 48197
United States
Dermatolgy and Skin Cancer Center
Lee's Summit, Missouri, 64064
United States
MediSearch, LLC
Saint Joseph, Missouri, 64506
United States
Montana Medical Research
Missoula, Montana, 59808
United States
Smith Allergy & Asthma Specialists of Central New York
Cortland, New York, 13045
United States
Sadick Research Group
New York, New York, 10075
United States
Bexley Dermatology Research
Bexley, Ohio, 43209
United States
Auni Allergy
Findlay, Ohio, 45840
United States
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
United States
Toledo Institute of Clinical Research
Toledo, Ohio, 43617
United States
Southern Plains Medical Center - Chickasha
Oklahoma City, Oklahoma, 73112
United States
Portland Allergy and Asthma
Clackamas, Oregon, 97015
United States
Oregon Medical Research Center
Portland, Oregon, 97201
United States
Clinical Research Philadelphia, LLC
Philadelphia, Pennsylvania, 18114
United States
National Allergy and Asthma Research, LLC - CRN - PPDS
North Charleston, South Carolina, 29420
United States
Alina Clinical Trials
Dallas, Texas, 75225
United States
VAST Clinical Research - Plano
Plano, Texas, 75033
United States
Allergy and Asthma Care of Waco
Waco, Texas, 76712
United States
Premier Clinical Research
Spokane, Washington, 99202
United States

Collaborators and Investigators

Sponsor: Celldex Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-11
Study Completion Date2027-04

Study Record Updates

Study Start Date2024-07-11
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • CDX-0159
  • barzolvolimab
  • chronic spontaneous urticaria
  • CSU
  • urticaria activity score
  • itch severity score
  • hives severity score

Additional Relevant MeSH Terms

  • Chronic Spontaneous Urticaria