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 (NCT05677451)
A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment
Who can join: Review the eligibility criteria below.
Location: Kern Research — Bakersfield, California
Age range: 12 Years to 17 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 (50 Sites)
Showing the first 25 of 50 sites.
- Kern Research — Bakersfield, California
- Allergy and Asthma Medical Group and Research Center — San Diego, California
- Pediatric Dermatology of Miami at the Pediatric CoE — Miami, Florida
- Treasure Valley Medical Research — Boise, Idaho
- Endeavor Health — Glenview, Illinois
- Allergy and Asthma Specialist P S C — Owensboro, Kentucky
- Toledo Institute of Clinical Research — Toledo, Ohio
- Allergy Asthma and Clinical Research — Oklahoma City, Oklahoma
- Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania
- RFSA Dermatology — San Antonio, Texas
- Allergy Associates of Utah — Sandy City, Utah
- Novartis Investigative Site — CABA, Buenos Aires
- Novartis Investigative Site — Rosario, Santa Fe Province
- Novartis Investigative Site — CABA,
- Novartis Investigative Site — San Miguel de Tucumán,
- Novartis Investigative Site — Montreal, Quebec
- Novartis Investigative Site — Santiago, Santiago Metropolitan
- Novartis Investigative Site — Guangzhou, Guangdong
- Novartis Investigative Site — Chengdu, Sichuan
- Novartis Investigative Site — Beijing,
- Novartis Investigative Site — Beijing,
- Novartis Investigative Site — Frankfurt am Main, Hesse
- Novartis Investigative Site — Berlin,
- Novartis Investigative Site — Tübingen,
- Novartis Investigative Site — Hong Kong, Hong Kong
💰 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
- A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria — 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 — 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.