RECRUITING

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

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-CSU2)

Quick Facts

Study Start:2024-07-19
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06455202

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)

Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd.
Scottsdale, Arizona, 85258
United States
Center for Dermatology & Plastic Surgery
Scottsdale, Arizona, 85260
United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
United States
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
United States
LA Universal Research Center, Inc.
Los Angeles, California, 90057
United States
Clarity Dermatology, PLLC
Castle Rock, Colorado, 80109
United States
Driven Research LLC
Coral Gables, Florida, 33134
United States
Deluxe Health Center
Miami Lakes, Florida, 33014
United States
Revival Clinical Research
Orlando, Florida, 32807
United States
Allergy and Asthma Diagnostic treatment Center - CRN - PPDS
Tallahassee, Florida, 32308
United States
Advanced Clinical Research Institute (ACRI) - Florida
Tampa, Florida, 33607
United States
Lane Dermatology Research - Centricity - PPDS
Columbus, Georgia, 31904
United States
Treasure Valley Medical Research
Boise, Idaho, 83706
United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168
United States
South Bend Clinic
South Bend, Indiana, 46617
United States
Henry J. Kanarek - Allergy,Asthma&Immunology
Overland Park, Kansas, 66211
United States
Velocity Clinical Research - The Dermatology Clinic - Baton Rouge - PPDS
Baton Rouge, Louisiana, 70808
United States
Continental Clinical Research Solutions, LLC - ClinEdge - PPDS
Towson, Maryland, 21204
United States
Derm Institute of Western Michigan
Caledonia, Michigan, 49316
United States
Clarkston Skin Research - Clarkston
Clarkston, Michigan, 48346
United States
Grekin Skin Institute
Warren, Michigan, 48088
United States
Skin Specialists PC
Omaha, Nebraska, 68144
United States
OptiSkin Medical
New York, New York, 10128
United States
Optimed Research Ltd - ClinEdge - PPDS
Columbus, Ohio, 43235
United States
Clinical Partners LLC
Johnston, Rhode Island, 02919
United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
United States
Jordan Valley Dermatology Center-South Jordan
South Jordan, Utah, 84095
United States
Virginia Dermatology and Skin Cancer Center - Norfolk
Norfolk, Virginia, 23502
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 Date2024-07-19
Study Completion Date2027-04

Study Record Updates

Study Start Date2024-07-19
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