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)
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in Chronic Spontaneous Urticaria
- Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension. โ CABA, Buenos Aires
- 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up โ Bakersfield, California
- A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria โ Birmingham, Alabama
- An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib โ Birmingham, Alabama
- Remibrutinib in Real-world Clinical Practice โ Kirksville, Missouri
Explore by condition: All Chronic Spontaneous Urticaria clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.