An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib (NCT05513001)
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 Studies
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this extension study is to collect long-term efficacy, safety and tolerability data on remibrutinib in a selected group of participants with Chronic Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib preceding Phase 3 core studies. This study will also fulfill the Novartis commitment to provide post-trial access to participants who have completed the preceding Phase 3 studies, where applicable.
Who can join: Review the eligibility criteria below.
Location: Allervie Clinical Research — Birmingham, Alabama
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (208 Sites)
Showing the first 25 of 208 sites.
- Allervie Clinical Research — Birmingham, Alabama
- Cahaba Derm and skin hlth ctr 27 — Birmingham, Alabama
- Research Solutions of Arizona — Litchfield Park, Arizona
- Acuro Research Inc — Little Rock, Arkansas
- Arkansas Research Trials — North Little Rock, Arkansas
- Kern Research — Bakersfield, California
- Antelope Valley Clinical Trials — Lancaster, California
- Allergy and Asthma Consultants — Redwood City, California
- Asthma and Allergy Associates P C — Colorado Springs, Colorado
- Colorado Allergy and Asthma Ctr PC — Denver, Colorado
- UCONN Health Dermatology — Farmington, Connecticut
- Florida Ctr Allergy Asthma Research — Aventura, Florida
- Finlay Medical Research — Greenacres City, Florida
- Miami Dade Medical Research — Miami, Florida
- Sarasota Clinical Research — Sarasota, Florida
- Allergy and Asthma Diagnostic Treatment Center — Tallahassee, Florida
- Aeroallergy Research Laboratories — Savannah, Georgia
- Treasure Valley Medical Research — Boise, Idaho
- Endeavor Health — Glenview, Illinois
- Asthma and Allergy Center of Chicago S C — River Forest, Illinois
- Deaconess Clin Allerg Res Inst — Evansville, Indiana
- The Indiana Clinical Trials Center — Plainfield, Indiana
- Allergy and Asthma Specialist P S C — Owensboro, Kentucky
- John Hopkins University — Baltimore, Maryland
- Institute for Asthma and Allergy PC — Chevy Chase, Maryland
💰 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 § 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. — CABA, Buenos Aires
- A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU) — Cullman, Alabama
- 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 — Bakersfield, California
- A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria — Birmingham, Alabama
- Remibrutinib in Real-world Clinical Practice — Kirksville, Missouri
Explore by condition: All Chronic Spontaneous Urticaria clinical trials
💡 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.