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. (NCT06042478)
A Global, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib 25 mg b.i.d. in Comparison to Placebo With Omalizumab 300 mg Every 4 Weeks as Active Control Over 52 Weeks in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines and an Open-label 52-week Optional Extension to Assess Long-term Efficacy, Safety and Tolerability of Remibrutinib 25 mg b.i.d.
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH). The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.
Who can join: Review the eligibility criteria below.
Location: Novartis Investigative Site — CABA, Buenos Aires
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 (110 Sites)
Showing the first 25 of 110 sites.
- Novartis Investigative Site — CABA, Buenos Aires
- Novartis Investigative Site — Mendoza, Mendoza Province
- Novartis Investigative Site — Rosario, Santa Fe Province
- Novartis Investigative Site — Bahía Blanca,
- Novartis Investigative Site — CABA,
- Novartis Investigative Site — Capital Federal,
- Novartis Investigative Site — Porto Alegre, Rio Grande do Sul
- Novartis Investigative Site — Alphaville Barueri, São Paulo
- Novartis Investigative Site — Santo André, São Paulo
- Novartis Investigative Site — Sorocaba, São Paulo
- Novartis Investigative Site — Sofia,
- Novartis Investigative Site — Sofia,
- Novartis Investigative Site — Varna,
- Novartis Investigative Site — Edmonton, Alberta
- Novartis Investigative Site — Hamilton, Ontario
- Novartis Investigative Site — Hamilton, Ontario
- Novartis Investigative Site — London, Ontario
- Novartis Investigative Site — Niagara Falls, Ontario
- Novartis Investigative Site — Québec, Quebec
- Novartis Investigative Site — Verdun, Quebec
- Novartis Investigative Site — Brno,
- Novartis Investigative Site — Plzen Bolevec,
- Novartis Investigative Site — Prague,
- Novartis Investigative Site — Nice, France
- Novartis Investigative Site — Grenoble,
💰 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
- 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
- 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.