๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-24

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) (NCT06455202)

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)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Celldex Therapeutics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Allervie Clinical Research - Cullman โ€” Cullman, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (245 Sites)

Showing the first 25 of 245 sites.

  • Allervie Clinical Research - Cullman โ€” Cullman, Alabama
  • Research Solutions of Arizona PC โ€” Litchfield Park, Arizona
  • Medical Research of Arizona a division of Allergy, Asthma, & Immunology, Assoc. Ltd. โ€” Scottsdale, Arizona
  • Center for Dermatology & Plastic Surgery โ€” Scottsdale, Arizona
  • Kern Research, Inc. โ€” Bakersfield, California
  • UCLA Clinical Trials Contracts & Strategic Relations โ€” Los Angeles, California
  • California Allergy and Asthma Medical Group โ€” Los Angeles, California
  • LA Universal Research Center, Inc. โ€” Los Angeles, California
  • Allergy and Asthma Associates of Southern Cal โ€” Mission Viejo, California
  • Huntington Asthma & Allergy Center โ€” Pasadena, California
  • Apex Clinical Research โ€” San Diego, California
  • WR-MCCR โ€” San Diego, California
  • University Clinical Trials โ€” San Diego, California
  • Clinical Science Institute โ€” Santa Monica, California
  • Raffi Tachdjian MD, Inc โ€” Santa Monica, California
  • Clarity Dermatology, PLLC โ€” Castle Rock, Colorado
  • Asthma and Allergy Associates โ€” Colorado Springs, Colorado
  • Driven Research LLC โ€” Coral Gables, Florida
  • Palm Beach Dermatology Group โ€” Delray Beach, Florida
  • Dolphin Medical Research โ€” Doral, Florida
  • South FL Clinical Research LLC โ€” Miami, Florida
  • Dade Florida Clinical Research Center โ€” Miami, Florida
  • Deluxe Health Center โ€” Miami Lakes, Florida
  • Revival Clinical Research โ€” Orlando, Florida
  • International Clinical Research - FL LLC โ€” Sanford, Florida

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—